Openings are listed for the following disciplines:
Clinical Applications (1) Engineering and Validation (5) Management (3) Materials / Supply Chain (2) Production / Packaging Management (4) Quality Assurance / Quality Control (8) Regulatory Affairs and Clinical Affairs (3) Research & Development (4) SALES and MARKETING (1)
Clinical Applications
Clinical Application Specialist
	The person we are looking for shall: See that our customers can make maximum use of their ScandiDos systems and ensure that ScandiDos meets customer satisfaction goals. Plan, schedule, and execute installations including organizing shipping of equipment. Handle incoming support issues and report into the customer complaint system. Participate in pre-sales demos and pre-sale presentations. Participate in trade shows and relevant meetings in radiation therapy and medical physics. Act as an interface between customers, product management, and sales withconsistent updates to all involved parties of activities. Have a background in support of equipment for radiation therapy or alternatively be an experienced end-user. The person shall be familiar with treatment planning systems, dosimetry systems and medical dosimetry. Have a background in medical physics, biomedical engineering or medical dosimetry. Be self-starting, structured and able to work as a team member both with colleagues in the US and with the main office in Sweden. Travel at least 100 days per year. Preferably located Central part of the USA. For more information about ScandiDose, you may visit their website at http://www.scandidos.se/?page_id=3&f=1_2_3 In addition to the CAS position you will see in the jobs tab that the company is also hiring a Regional Sales Executive for the West Coast. The compensation for both opportunities will be competitive and include benefits.
	Location  Central part of USA Consultant  Scott McCay
Engineering and Validation
Validation Specialist
	Job Description Support and maintain a validation program that meets regulatory requirements. Write validation protocols and reports. Evaluate validation data that is included in validation reports. Must have knowledge of the validation approach for IQ/OQs and PQs.  Must also have knowledge of Process Validation, Packaging Validation and Cleaning Validation and Computer Validation. Requires a bachelor's degree in Science or Engineering with 1 to 3 years of validation experience or associates degree with 5-7 years of validation experience in a pharmaceutical and/or nutraceutical industry.
	Location  SC Consultant  Lee Douglas
Director / Sr. Director Engineering
	Must have ASEPTIC (NO EXCEPTIONS) Pharmaceutical background with experience in building new facilities with focus on the parenteral & injectables rather than solid dosage, etc. Direct Engineering, Facilities Maintenance, Freeze Dryer Maintenance, Metrology and Sanitation departments. Reports: 4 Direct; 120 indirect ... MUST be a strong LEADER. Bachelor degree prefer Mechanical, Chemical, or related Engineering discipline. Advanced degree a plus. Study in interpersonal relationships and management skills is essential. Good technical skills in the operation and maintenance of equipment and utilities is essential, as well as skills in the management of construction projects and personnel. Position requires: Min. 15 yrs experience in engineering and Maintenance management. Hands-on experience maintaining equipment, buildings, and utilities. Construction project management and equipment troubleshooting experience required. Pharmaceutical manufacturing facility design and construction experience is highly required.
	Location  OH Consultant  Lee Douglas
SENIOR PROCESS DEVELOPMENT ENGINEER
	SUMMARY Responsible for working with the R&D teams to ensure appropriate processes and equipment are used to assure producibility of new products. Recommends and implements equipment and process upgrades to meet this goal. Develops and/or tests new types of equipment and processes to allow production of new types of products and/or increase product quality. ESSENTIAL DUTIES AND RESPONSIBILITIES Analyzes, develops and recommends equipment and methods to meet production requirements for new or improved products and processes. Works closely with R&D organization to ensure products in development will be efficiently producible in a production environment. Recommends equipment and process changes to improve quality and reduce costs by providing technical analysis and input. Provides technical guidance and liaison to production personnel. Works closely with other departments and in cross-functional teams to resolve problems or to respond to technical issues. Keeps up to date with latest manufacturing technologies and regulations. Produces clear, accurate and thorough technical documentation for production processes and development projects. Supports validation of new processes and equipment. Coordinate activities with outside suppliers and consultants to ensure delivery of equipment, supplies and services to meet scheduled timelines. Prepare engineering cost estimates and project budgets. Conduct preliminary financial analysis for projects. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Additionally, an individual must uphold the standards of conduct of the company, which include confidentiality, cooperation, and respect for people and property. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION AND EXPERIENCE: BA/BS degree in an engineering field and 6+ years of experience, preferably in a pharmaceutical manufacturing environment. Should have strong knowledge of liquid and/or semi-solid mixing technologies. Should have broad-base knowledge of manufacturing processes and equipment. Should have an understanding of cGMPs and validation processes. Process automation and control experience is beneficial.
	Location  North Carolina Consultant  Phil Ellis
Validation Engineer
	This is a new position created due to the continued growth and expansion of this NC based pharmaceutical manufacturer. A great location with low COL. Compensation is competitve and commensurate with experience we are seeking. Works with company personnel and external customers to coordinate the implementation of new and transferred products into the manufacturing facility Participates on and/or leads project teams working to implement new equipment and systems, changes to existing equipment and systems, facility expansions, new and transferred projects , and process optimizations. Participates in peer review of validation documents developed and executed by others. Writes and executes protocols for IQ/OQ/PQ validation for plant processes and utility support; process and cleaning validation; process cycle development and process development; and, computer validation. Documents, tests, and validates changes made to validated systems. Writes and/or reviews final summary reports for above listed protocols. The successful candidate will have a Bachelor's degree in a technical discipline ( engineering, life sciences or computer sciences ) and a minimum of 2 to 4 years validation experience.
	Location  NC Consultant  Phil Ellis
Contract Manufacturing Manager
	For this fast growing pharma manufacturing company located in a very desireable area of NC: Summary: 1.    Responsible technical support and management of outsourcing projects at Third Party contract packagers. The incumbent will be responsible for supporting projects relating to both finished product and packaging outsourcing. The scope of technical oversight at Third Parties includes finished product processing, packaging, components, controls and evaluation for US Operations. This includes specific responsibility for the oversight and implementation of finished product and packaging technology transfer projects into selected Third Party suppliers. 2.    The incumbent is responsible to ensure timely and effective implementation of improved processes for Third Party drug product and packaging projects and processes.  Activities also include ensuring that processes and projects are efficiently and effectively implemented, to support goals of quality, cost and customer service, and to ensure compliance to all cGMPs, industry regulations, company guidelines, SOPs and policies pertinent to work performed. 3.    Plans and manages, the design, development and testing of container/closure systems.  Determines packaging design requirements.  Develops comprehensive test plans and performs and/or oversees experiments that benchmark packaging performance and insure all design requirements have been met   Responsible for package engineering projects and specifications for all DTM and contract packaging activities.  Assures that component specifications are issued in a timely manner to support clinical and commercial packaging activities.  Maintains package engineering files and component histories and drafts container closure sections for regulatory filings. 4.    Work with Marketing and Sales in the development and launch of new products by coordinating requirements with plant operations and third party suppliers. Manage bulk inventory level, coordinate contract packaging volumes, and demand requirements to manufacturing to meet inventory goals and meet on-time delivery requirements. 5.    Manages and develops staff in execution of daily activities required to achieve departmental goals and accomplish departmental responsibility. EDUCATION AND EXPERIENCE: ·    B.S. degree in Engineering, Science or equivalent. ·    A minimum of 3-5 years relevant packaging Engineering experience in solid dose packaging operations plus 7-10 years contract or in-house management of packaging operations. Project management in packaging or related contract services, preferably within or serving the pharmaceutical or nutritional industry preferred. ·    Experience in packaging manufacturing and technology is required; with pharmaceutical or nutritional products preferred.  Experience in product costing, distribution channels, and FDA regulations are required. ·    Excellent verbal and written skills and the ability to communicate with internal and external customers is a must.  Effective presentation skills are strongly desired. ·    Demonstrated understanding of production and logistics planning. ·    Working knowledge of Materials Management concepts and planning systems.  Working knowledge of Microsoft Office applications, particularly Word, Excel, PowerPoint, Visio and Project
	Location  NC Consultant  Phil Elllis
Management
Manager, Project Management
	Manages the Project Management department within R&D to assure progress toward critical milestones of company’s strategic plan.  Ensures the successful planning, development, administration, and execution of the new product development process.  This includes identifying company needs, defining scope, estimating labor, technology, and capital resource needs, and measuring and reporting the performance of the project management group.  Persons in this position will also directly manage some development projects and provide support of project management processes at other sites. BA/BS degree in technical field/business with 8+ years OR, MS/MBA degree with at least 5-8 years of pharmaceutical industry and/or project management experience.  Knowledge of drug product development, relevant government regulations and cGMP’s is required.
	Location  NC Consultant  Lee Douglas
GENERAL MANAGER
	Sr. Director, General Manager Job Description The General Manager/Senior Plant Director (GM) is responsible for managing all business activities, directing site senior management and developing strategic business initiatives at the  site.  The GM represents the company on legal/statutory issues with government bodies such as State Department of Health, United States Food and Drug Agency, and Chamber of Commerce officials.  The GM interfaces with other pharmaceutical companies, patient groups, scientific organizations, main customers, suppliers, health authorities and key opinion leaders. The GM is responsible for compliance with US/Local employment laws. The GM is responsible for carrying out the manufacturing operations that exist at the facility in a manner consistent with the expectations of company culture and business principles. Specific Job Requirements Develops medium and long term strategic objectives for the site and leads the management team in the development and implementation of operational plans. Communicates and creates buy in for the business plans and vision for the future to ensure strategic goals and operating budgets are achieved. Leads the development of the site forecasts and budgets in collaboration with departmental heads and guidance from the Commercial SVP.  Manages site expenses in accordance with the approved budget.  Maintains a detailed budgetary analysis and acts upon budget deviations. Determines operational headcount projections with his/her senior management team. Manages, coaches and develops staff, Undertakes periodical and regular meetings with direct reports and contributes to establishing goals and objectives. Coordinates all departments at local level in the planning and administration of the schedule of activities. Carries out effective control of tasks and matters, which require a periodic performance review. Fulfills the established terms for programmed activities. Effectively ensures coordination and distribution of information on documentation, materials, site results and activities to relevant stakeholders including the Commercial SVP as requested. Establishes strong relationships with local and international key opinion leaders and represents company in local communication campaigns when necessary. Demonstrates collaboration, cooperation with people in all departments of the company. Updates on regular basis his/her knowledge regarding all company products and the diseases area and other areas of interest for his/her job (finances, regulatory, employment law and general market conditions). As site leader, carries out his/her work respecting the policies and internal procedures of the company. Maintains confidentiality and discretion on matters and with information they manage. Distributes and plans his/her activities efficiently, in accordance with the priorities and optimizes the use of his/her time. Knowledge Leads the strategic management and operational development of strategy for the site. The role of a General Manager requires a broad range of business skills. He or she should demonstrate a good understanding of strategy and operational management, including improving business performance using the resources available and sustaining a continuous improvement culture. Strong financial understanding of general and cost accounting essential.  A high level of communication and leadership skills to ensure effective cross-functional working and clear understanding of the company goals.  Leadership and direction are important so that company wide objectives are achieved.   This role will require a person able to understand and manage a wide range of responsibilities.  Must be able to interpret, execute, and recommend modifications to company-wide policies to achieve corporate goals and objectives.   Must have in-depth expertise in U.S and international GMPs. Demonstrated experience in the following areas: Leadership and group working skills: including leadership, team-working and coaching skills. Strategic analysis: including knowledge of the organizational environment, strategic analysis methods, formulation and implementation of business plans and new product development. Finance: understanding financial planning and budgeting, using capital investment pro forma to develop capital investment assessments. Marketing: understanding customer value, developing competitive advantages and core competencies. Operation: developing resource plans and continuous improvements. Information management: use of information as a strategic asset. Human resources management: understanding the value of people in organizations, knowledge of strategic processes to develop individual and organizational capabilities, organizational development, change management processes and culture. Personal skills: time management, report writing, presentation and basic PC skills.  Specific Education and Experience Requirements Typically requires a BA or BS degree in Business Management, Science or Engineering and minimum 16+ years of relevant experience in related field. Alternately, an MS/MA or MBA degree and minimum 14 years of relevant experience. Must have pharmaceutical background with emphasis on aseptic manufacturing.  Facility is a multi-product manufacturing and distribution facility.
	Location  USA Consultant  Phil Elllis
Vice President, Manufacturing
	Fast growing producer of monoclonal antibodies and other bio-pharma products is transitioning from clinical scale manufacturing to commercial scale manufacturing. We need an individual with commercial scale cGMP manufacturing management experience at the Director / Sr. Director / Vice President level to join the team to guide this transition and manage the operation, including substantial capital improvement activity. A BS in Science or Engineering is required, advanced degree much preferred. Experience in the manufacture of commercial scale quantities of multi-product bio-pharma products for 10+ years is required. Very competitive compensation, bonus, relocation assistance provided. Beautiful area with very high quality of living.
	Location  WA Consultant  Lee Douglas
Materials / Supply Chain
Manager, External Supply Chain
	For this major, multi-national pharma company located near Denver, CO. Job Description : Position Summary: The Manager, External Supply Chain will manage the external supply base [3rd party and intercompany] implementing policies and processes which ensure an optimized and integrated sourcing system that meets customer requirements, minimizes total supply chain cost, maximizes supply chain effectiveness including conforming to established quality standards, and establishes an inventory flow that is responsive to the needs of the business. This position reports to Director, External Supply Chain. Education: Bachelor's degree Work Experience: 5+ years experience in purchasing and/or planning Certifications: APICS certification desired Effective organizational skills in handling multiple priorities and meeting required budget goals and deadlines. Well-developed interpersonal skills for effective management. Experience with Enterprise requirements planning systems (preferably SAP). PC skills with spreadsheets and database applications.
	Location  Colorado Consultant  Lee Douglas
Warehouse Manager
	Summary: The Warehouse Manager is responsible for the overall operations management of multiple warehouses operating in support of High Point manufacturing, Receiving and Distribution activity. Key functional responsibilities include area facility and budget management, safety, inventory transactional integrity and all freight management.  The Manager role is expected to identify, recommend and implement approved changes in business processes, monitor and report progress toward achievement of goals and objectives, and report on key daily operational metrics.   The Warehouse Manager works extensively with Supervisors and Managers from other functions in achievement of daily goals and ensures consistent compliance with cGMP and SOP's.   EDUCATION AND EXPERIENCE:   The position requires a minimum of a Bachelors Degree, and 8 years experience directly managing Warehouse operations, or equivalent combination of education and minimum 13 years work experience directly managing Warehousing operations that gives the individual the necessary knowledge, skills and abilities to do the job.  The Warehouse management experience must have included direct management of Receiving, Warehousing, Shipping, and Inventory Control functions supporting manufacturing operations in a lot controlled business environment dealing with at least several hundred active SKU’s and total inventory valued of approximately $15+MM. Working knowledge of C-TPAT and FTZ requirements, certification process, and maintenance of the same is required. Also must have a thorough understanding of cGMP requirements as they impact warehouse and distribution operations, and be able to manage business activities in compliance with these regulations. Must have previous experience using and managing daily operations with a major ERP system. Knowledge of Customs regulations, import and export processes is a plus. Previous experience with Smart Zone software, and/or SAP software systems, is a plus.
	Location  Triad area of NC Consultant  Lee Douglas
Production / Packaging Management
GENERAL MANAGER
	Sr. Director, General Manager Job Description The General Manager/Senior Plant Director (GM) is responsible for managing all business activities, directing site senior management and developing strategic business initiatives at the site.  The GM represents the company on legal/statutory issues with government bodies such as State Department of Health, United States Food and Drug Agency, and Chamber of Commerce officials.  The GM interfaces with other pharmaceutical companies, patient groups, scientific organizations, main customers, suppliers, health authorities and key opinion leaders.  The GM is responsible for compliance with US/Local employment laws. The GM is responsible for carrying out the manufacturing operations that exist at the  facility in a manner consistent with the expectations of company culture and business principles. Specific Job Requirements Develops medium and long term strategic objectives for the site and leads the management team in the development and implementation of operational plans. Communicates and creates buy in for the business plans and vision for the future to ensure strategic goals and operating budgets are achieved. Leads the development of the site forecasts and budgets in collaboration with departmental heads and guidance from the Commercial SVP.  Manages site expenses in accordance with the approved budget.  Maintains a detailed budgetary analysis and acts upon budget deviations. Determines operational headcount projections with his/her senior management team. Manages, coaches and develops staff, Undertakes periodical and regular meetings with direct reports and contributes to establishing goals and objectives. Coordinates all departments at local level in the planning and administration of the schedule of activities. Carries out effective control of tasks and matters, which require a periodic performance review. Fulfills the established terms for programmed activities. Effectively ensures coordination and distribution of information on documentation, materials, site results and activities to relevant stakeholders including the Commercial SVP as requested. Establishes strong relationships with local and international key opinion leaders and represents company in local communication campaigns when necessary. Demonstrates collaboration, cooperation with people in all departments of the company. Updates on regular basis his/her knowledge regarding all company products and the diseases area and other areas of interest for his/her job (finances, regulatory, employment law and general market conditions). As site leader, carries out his/her work respecting the policies and internal procedures of the company. Maintains confidentiality and discretion on matters and with information they manage. Distributes and plans his/her activities efficiently, in accordance with the priorities and optimizes the use of his/her time. Knowledge Leads the strategic management and operational development of strategy for the site. The role of a General Manager requires a broad range of business skills. He or she should demonstrate a good understanding of strategy and operational management, including improving business performance using the resources available and sustaining a continuous improvement culture. Strong financial understanding of general and cost accounting essential. A high level of communication and leadership skills to ensure effective cross-functional working and clear understanding of the company goals.  Leadership and direction are important so that company wide objectives are achieved.  This role will require a person able to understand and manage a wide range of responsibilities.  Must be able to interpret, execute, and recommend modifications to company-wide policies to achieve corporate goals and objectives.  Must have in-depth expertise in U.S and international GMPs. Demonstrated experience in the following areas: Leadership and group working skills: including leadership, team-working and coaching skills. Strategic analysis: including knowledge of the organizational environment, strategic analysis methods, formulation and implementation of business plans and new product development. Finance: understanding financial planning and budgeting, using capital investment pro forma to develop capital investment assessments. Marketing: understanding customer value, developing competitive advantages and core competencies. Operation: developing resource plans and continuous improvements. Information management: use of information as a strategic asset. Human resources management: understanding the value of people in organizations, knowledge of strategic processes to develop individual and organizational capabilities, organizational development, change management processes and culture. Personal skills: time management, report writing, presentation and basic PC skills. Specific Education and Experience Requirements Typically requires a BA or BS degree in Business Management, Science or Engineering and minimum 16+ years of relevant experience in related field. Alternately, an MS/MA or MBA degree and minimum 14 years of relevant experience. Must have pharmaceutical background with emphasis on aseptic manufacturing.  Facility is a multi product manufacturing and distribution facility.
	Location  USA Consultant  Phil Elllis
Director of Manufacturing
	SUMMARY Directs and coordinates manufacturing activities of the plant to obtain optimum efficiency, safety, compliance and economy of operations to maximize profits. ESSENTIAL DUTIES AND RESPONSIBILITIES Plans, develops, and implements manufacturing organization policies and goals. Coordinates activities of responsible departments to include: Gelatin and Medicine, Encapsulation and Post Production manufacturing, to effect operational excellence, efficiency, regulatory compliance and safety in support of the production schedule. Establishes goals and objectives for the responsible manufacturing departments, which are based on company objectives and budget requirements for the year. Demonstrates a broad understanding of and ability to follow; cGMPs, DEA, FDA and other applicable regulatory guidelines. Reviews activity, operating, and sales reports to determine changes in programs or operations required to meet customer needs and efficiency. Directs communication to plant manager outlining policy, program, or operations changes to be implemented. Contribute to SOP and Work Instruction development to satisfy FDA, DEA and other applicable regulatory guidelines. Manages all audits to ensure all manufacturing operations are in compliance with GMPs and related SOPs at all times. Supports and oversees innovative ways to reduce cycle times and cost while maintaining or increasing quality utilizing 6 Sigma and LEAN Principles. Oversees and directs daily production requirements and resolves operational, quality, manufacturing, and maintenance problems to ensure maximum efficiencies and to prevent operational delays. Directs adjustments in production activities as needed. Participates in meetings, including daily scheduling meeting and others as required to maintain overall manufacturing effectiveness. Establishes procedures to ensure consistency of operation in manufacturing. Coordinates with plant manager to achieve the strategic goals of the company and communicates and executes with direct reports. Directs and supports products manufactured or services performed in: development of new markets, increase share of market, and to obtain competitive position in the industry. Works with the Human Resources Department to ensure policies, benefits, and growth development plans are implemented. Analyzes manufacturing department budget requests to identify areas in which reductions can be made, and allocates departmental operating budget accordingly. Provides general direction and scope of authority and responsibilities to direct reports. Performs regular appraisal of work performance of direct reports. Performs other reasonable, related business duties as required. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Additionally, an individual must uphold the standards of conduct of the company, which include confidentiality, cooperation, and respect for people and property. The requirements listed below are representative of the knowledge, skill, and/or ability required: Team Player, Results Driven, Exhibits Integrity, Excellence, Stewardship, Innovation and Learning & Growth skills. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION AND EXPERIENCE: BA/BS in technical or manufacturing field and 10 years of direct manufacturing experience in the pharmaceutical or chemical industries, or equivalent combination of education and experience. Experience should also include management of multi-disciplined workforce at all levels. Preferable experience would include contract manufacturing and/or solids, capsules or softgel manufacturing. LANGUAGE SKILLS: Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Ability to effectively present information to top management, public groups, and/or boards of directors. Ability to respond effectively to the most sensitive inquiries or complaints. Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to write speeches and articles for publication that conform to prescribed style and format. MATHEMATICAL SKILLS: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. REASONING ABILITY: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. OTHER SKILLS AND ABILITIES: Ability to use a PC and the following software: Microsoft Office suite, including Work, Excel, and PowerPoint, Windows, Calendar, and Lotus Notes. Ability to make decisions. Highly developed and effective interpersonal skills are required. CERTIFICATES, LICENSES, REGISTRATIONS None required. SPECIAL REQUIREMENTS Must meet applicable DEA security clearance requirements. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function. While performing the essential duties of this job, the employee is occasionally required to stand and walk. The employee is frequently required to sit. The employee is regularly required to talk/hear/listen (communicate with others). There are no lifting (weight) requirements or special vision requirements. WORK ENVIRONMENT The noise level is normal for both office and factory environment. Competitive salary and bonus with good relo in a low COL area in NC.
	Location  NC Consultant  Phil Ellis
Team Leader (Production Supervisor)
	Job Description Directs a multifunctional team responsible for producing product in conformance with regulatory requirements, cGMPs, within company policies and goals Manages the overall activities of a large functional area within the organization's manufacturing facility. Ensures Sandoz's compliance with all cGMPs, SOP's, FDA, HSE and DEA regulations within the assigned area, working to ensure synergies and maximization of global economies of scale. Implements continuous improvement processes and projects that provides consistency in local and global policies. Establishes solid relationships with QC, QA, Engineering, Facilities Maintenance and Validation toward the appropriate balance of cost, production, quality, and safety of the organization to ensure adequate production supply. Performs statistical analysis of manufacturing data, trending and improvement measures. Partners with Planning to ensure adequate supply of materials and with Supply Chain to ensure availability of products to external customers. Directs the activities of resources, both internal and outside contractors/vendors, with similar technical or functional responsibilities. Responsible for implementing operational and strategic policies and directives. Develops functional processes for area managed. Interfaces with senior management to report on project and program milestones and to present project needs. Requires the ability to influence others to achieve results. Assignments are given in the form of objectives with no process defined. May or may not manage lower-level supervisors. Provides project and program milestones updates and presents project needs to direct manager.  Assignments are provided in a direct manner with basic processes defined. Manages production supervisors ensuring the appropriate compliance of human resources and legal policies/procedures. Requirements Strong oral and written communication and management skills in a team environment. Self directed, motivated and ability to operate independently. This position will be responsible for a team including all support individuals required to support the production of the assigned functional area. Direct reports will include: planning, technical support, engineering, maintenance, organizational excellence engineers, manufacturing supervisors and packaging supervisors for all shifts. Education: 4 Year Degree Required - BS/BA.  Science/Engineering preferred. Work Experience: Minimum 4 - 6 years of direct management experience. Minimum of 8 years pharmaceuticals.  Solid dose manufacturing experience preferred.
	Location  North Carolina Consultant  Lee Douglas
Manger, Contract Manufacturing
	For this fast growing pharma manufacturing company located in a very desireable area of NC: Summary: 1.    Responsible technical support and management of outsourcing projects at Third Party contract packagers. The incumbent will be responsible for supporting projects relating to both finished product and packaging outsourcing. The scope of technical oversight at Third Parties includes finished product processing, packaging, components, controls and evaluation for US Operations. This includes specific responsibility for the oversight and implementation of finished product and packaging technology transfer projects into selected Third Party suppliers. 2.    The incumbent is responsible to ensure timely and effective implementation of improved processes for Third Party drug product and packaging projects and processes.  Activities also include ensuring that processes and projects are efficiently and effectively implemented, to support goals of quality, cost and customer service, and to ensure compliance to all cGMPs, industry regulations, company guidelines, SOPs and policies pertinent to work performed. 3.    Plans and manages, the design, development and testing of container/closure systems.  Determines packaging design requirements.  Develops comprehensive test plans and performs and/or oversees experiments that benchmark packaging performance and insure all design requirements have been met   Responsible for package engineering projects and specifications for all DTM and contract packaging activities.  Assures that component specifications are issued in a timely manner to support clinical and commercial packaging activities.  Maintains package engineering files and component histories and drafts container closure sections for regulatory filings. 4.    Work with Marketing and Sales in the development and launch of new products by coordinating requirements with plant operations and third party suppliers. Manage bulk inventory level, coordinate contract packaging volumes, and demand requirements to manufacturing to meet inventory goals and meet on-time delivery requirements. 5.    Manages and develops staff in execution of daily activities required to achieve departmental goals and accomplish departmental responsibility. EDUCATION AND EXPERIENCE: ·    B.S. degree in Engineering, Science or equivalent. ·    A minimum of 3-5 years relevant packaging Engineering experience in solid dose packaging operations plus 7-10 years contract or in-house management of packaging operations. Project management in packaging or related contract services, preferably within or serving the pharmaceutical or nutritional industry preferred. ·    Experience in packaging manufacturing and technology is required; with pharmaceutical or nutritional products preferred.  Experience in product costing, distribution channels, and FDA regulations are required. ·    Excellent verbal and written skills and the ability to communicate with internal and external customers is a must.  Effective presentation skills are strongly desired. ·    Demonstrated understanding of production and logistics planning. ·    Working knowledge of Materials Management concepts and planning systems.  Working knowledge of Microsoft Office applications, particularly Word, Excel, PowerPoint, Visio and Project
	Location  NC Consultant  Phil Elllis
Quality Assurance / Quality Control
Senior Director, Quality Assurance
	We are seeking a seasoned Quality Assurance Executive with experience in global manufacturing operations and in-depth knowledge of regulatory/compliance requirements.  This role will be responsible for administrating standards of quality practices that encompass an integrated multi-national organization of external CMO’s and internal manufacturing locations.  This Quality professional will need to interact with all levels of the organization on global policy and guidance for the manufacturing and global distribution of Biopharmaceutical products.  The candidate will need to balance the requirements from a quality perspective of manufacturing internal produced products versus the utilization of a broad portfolio of third party contract manufacturers. International expertise of GMP’s across multiple business functions through harmonization of procedures and best practices. Job Function: Develops, establishes and maintains quality assurance programs and systems, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency requirements to ensure customer and regulatory satisfaction.  Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance. Will serve as liaison between the company and the various governmental agencies. Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications. Establishes and ensures business partners achieve the appropriate levels of compliance and develops actions to ensure ongoing performance is achieved and maintained through metrics and other forms of KPI’s. Establishes and ensures policy throughout the commercial manufacturing enterprise for the adherence to CFR, EMEA, and all other government agencies in which business is conducted. Direct quality systems as they pertain to the technical transfer from late stage development through NDA approval and commercial scale.  Ensure ongoing validated state of all commercial product. Ability to work with commercial, regulatory, and most corporate functions. Lead a group of 14 Quality Assurance professionals. Knowledge, Experience, Skills: Typically requires a BA or BS degree and a minimum of 15+ years of operational quality and manufacturing experience in a pharmaceutical or biotech environment. An advanced degree in science or business administration is desired. Must be able to develop and improve advanced concepts, techniques, and standards and new applications based on quality principles and theories. Must be able to develop solutions to problems of unusual complexity, which require a high degree of ingenuity, creativity and innovativeness. Challenges are frequently unique and solutions may serve as precedent for future decisions which effect the entire organization. Must be able to interpret, execute, and recommend modifications to company-wide policies to achieve corporate goals and objectives. Must have in-depth expertise in U.S., EU and international GMPs. Must understand standards of practice for the manufacture of API, solid dosage form, aseptic solution and other non-sterile dosage preparations. Must have effective communication skills and the ability to deal across several multi-national agencies and organizations. Establishes and communicates vision, focus and direction to align organizational and individual action and achieve results. Creates a “learning” culture that enables individuals to reach their maximum potential and builds the capability of the organization. Effectively manages talent to strengthen Gilead. Creates an exceptional working environment that motivates high performance. Communicates a clear vision and expectations that create energy, enthusiasm and commitment from others.
	Location  Consultant  Phil Elllis
Senior Manager, Compliance
	This is a newly created position that reports to the Site QA Director for this growing pharmaceutical company that produces sterile liquids ( aseptic), semi-solids and other dosage forms. Requires a minimum of a BS degree and 10+ years experience. Competitve salary and benefits. Great low COL location. Job Function Plan, manage, and provide Leadership for the activities of personnel with various levels of responsibilities within the Compliance team. Develop and authorize the implementation of site policies and procedures (SOPs) to assure compliance with government requirements (FDA, MHRA, etc.), and corporate policies. Participate as a member of the site Senior Management Team developing site strategies, policies, and successfully implementing the same. Work with Quality Directors to assure alignment of policies and procedures between and within sites. Must be able to represent the company with customers and regulatory agencies. Essential Duties and Responsibilities Site Compliance: ensure site is compliant with applicable quality and regulatory requirements for cGMP, QSR, and cGLP regulations. Manage FDA, MHRA, (and other regulatory bodies) and Customer Audits. This includes preparation for and managing responses to FDA and client audit reports, managing CAPA, and tracking other regulatory commitments for the site. Budgets: Develop and manage budgets for the Compliance Team in support of business initiatives and strategies. Customer Interface: Develop and maintain relationships with Customers for current and future products. Internal Audits: Develops plans for and manages the internal audit activities, reporting to management and tracking associated commitments. Performs GAP analysis and manages corrective action. Vendor Audits: In conjunction with Purchasing and QC, identify and manage vendor and service provider audits. Ensure the audit, whether performed by an auditor or a contracting firm, addresses regulatory requirements. Manage corrective actions. Regulatory Expertise: Develop and maintain regulatory expertise and knowledge of industry trends. Advise the organization in matters relating to cGMP, QSR, NDA/OTC requirements, and other regulatory policies and changes being implemented by regulatory agencies. Quality Agreements: Develops standard quality/technical agreements and manages these agreements in conjunction with customers, vendor and contract lab facilities. Other duties as Assigned
	Location  Warm with a low COL Consultant  Phil Ellis
QA Technical Services Manager
	Our client is a growing pharmaceutical company in a beautiful ( and low COL) area of NC. This is a new position so an opportunity to set the standards of performance for this job. Salary and bonus structure are competitve and commensurate with experience. Good relocation and temporary living program. SUMMARY The Quality Assurance Technical Services Manager is responsible for ensuring that quality technical professional support is in place and effectively supporting all R&D, Production Operations, and QA/QC activities falling under the jurisdiction of the cGMPs and comparable global regulatory agencies. This includes ensuring the quality of line operations work outputs and the compliance of work practices. The incumbent will accomplish this by delegating these responsibilities to Quality Engineers who will work directly with line operations colleagues in the planning and execution of operations activities rather than inspecting for defects after the work has been completed. The Quality Assurance Technical Services Manager will employ working knowledge of regulations and quality management principles in the conduct of his/her responsibilities. Further, his/her organization will collect, evaluate and interpret performance indicator data to identify sub standard performance and/or performance improvement opportunities. The Quality Assurance Technical Services Manager has the authority to approve Standard Operating procedures, client based study plans, validation/qualification protocols, technical investigations, and other documents requiring Quality Assurance review and approval. The Quality Assurance GMP Technical Services Manager will have the responsibility of working across functional lines to facilitate project teams in the implementation of quality or compliance improvement. He/she is viewed as a subject matter expert on regulatory compliance, operational quality, work process design and control, and technical problem solving. As such he/she is highly visible and demonstrates highly effective oral and written communication skills. His/her ability to create a team approach to the management of quality and compliance is a critical success factor for the incumbent. Essential Duties and Responsibilities Applies an advanced knowledge of regulatory compliance requirements and operations quality principles across regulated operations. Ensures proper implementation of the Quality Management System (QMS) through evaluation of SOPs, operational adherence to SOPs, and timely remediation of non-compliance with QMS standards. Leads cross functional teams engaged in quality/compliance improvement activities. Facilitates the increased quality/compliance knowledge of line operations. Serves as primary resource and technical subject matter expert to line operations in areas of troubleshooting, problem solving, process/method improvement, and the assuring the quality and compliance of these activities. Directs complex technical and/or organizational problem solving activities using proven tools such as statistical analysis, screening experiments, Design of Experiments (DOE) etc. Identifies negative trends in quality/compliance and ensures correction of root causes of deficiencies. Maintains current knowledge of global regulations and quality standards associated with operations. Reviews and approves Standard Operating Procedures, study design plans, qualification and/or validation protocols, investigational test plans, investigation reports, change control requests and other operational documentation where QA review and approval are required. Makes sound judgments and decisions and provides proper advice on issues of regulatory compliance and/or work product quality nature. Drives the implementation and enhancement of policies and procedures consistent with global health regulatory agencies, customer expectations, and fundamental principles of quality. Assure the identification and implementation of advanced quality and compliance management principles and techniques resulting in positive changes in operations, established collaborative relationships with operations, business development and support group leaders across Banner Communicates effectively with personnel at all levels. Maintains excellent relationships and professional network within the industry and with health regulatory agency representatives. Manages the Quality Assurance Technical Services staff, ensuring its effectiveness and professional development. Develops and manages the Quality Assurance Technical Services annual budget Assumes leadership role in managing projects, develops technical and organizational recommendations with significant impact, and uses influence to drive ongoing improvement of quality and compliance. Facilitates alignment of quality/compliance and line operations on quality/compliance issues. Performs other reasonable, related business duties. Supervisory Responsibilities This position supervises the Quality Assurance Technical Services Department. The titles directly supervised include Quality Engineer, Investigations Coordinator and Product Quality Services Coordinator. Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Additionally, an individual must uphold the standards of conduct of the company, which include confidentiality, cooperation, and respect for people and property. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must use effective time and project management skills in carrying out responsibilities. Demonstrates ability to independently handle multiple projects simultaneously. Articulates and supports strategy, direction, and decisions, assuring their proper execution within the Quality organization Demonstrates role model behavior consistent with company values Education and Experience BA/BS degree in a technical discipline and 6-8 years of experience in GMP compliance within the pharmaceutical industry, or equivalent combination of education and experience. Language Skills Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors. Ability to read, analyze and interpret the most complex documents. Ability to respond effectively to the most sensitive inquiries or complaints. Mathematical Skills Ability to apply mathematical operations, to such tasks as frequency distribution, determination of test reliability, and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Ability to comprehend and apply principles of advanced calculus, modern algebra, and advanced statistical theory. Reasoning Abillity Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases. Other Skills and Abilities Ability to use complex technical and/or organizational problem solving activities using proven tools such as statistical analysis, screening experiments, Design of Experiments (DOE) etc. Certificates, Licenses, Registrations Six sigma black belt and/or CQE preferred. Special Requirements Must meet applicable DEA security clearance requirements. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function. While performing the essential duties of this job, the employee is frequently required to stand, walk, and reach with hands and arms. The employee is regularly required to sit, use hands to finger, handle or feel, talk, hear or listen, communicate with others. There are no lifting requirements. There are no special vision requirements. Work Requirement The employee may be occasionally exposed to fumes or airborne particles and toxic or caustic chemicals. The noise level is moderate. Personal Protective Equipment None required, unless entering production
	Location  NC Consultant  Phil Ellis
Director, QA
	The company is a world leader in pharmaceuticals manufacturing. This site is one of the largest solid dosage production facilitiesin the USA. Competitive salary and benefits. Job Description : The Director of Quality Assurance is responsible for daily quality activities and cGMP compliance relating to the manufacture, packaging, quality control and distribution of drug products. This position oversees site quality systems, batch release, compliance, manufacturing quality, and e-compliance, in accordance with GxP and Company policies and procedures. This position provides strategic and tactical direction for site Quality Assurance organization. This position is responsible for developing and facilitating implementation of operational and strategic policies and directives, directing the activities of resources, both internal and outside contractors/vendors for site Quality Assurance department. Responsible for oversight, management and leadership of all Quality responsibilities including training, internal audits, investigations, complaints, CAPAs, change control APRs, document control, incoming inspection, manufacturing/lab oversight and product disposition. Company representative of Sandoz position and policy during FDA, DEA, EMEA and other regulatory agency investigations relating to cGMP inspections, customer complaint follow-ups, product recalls and pre/post drug product NDA/ANDA approval inspections. Set internal quality procedures ensuring implementation and adherence to Global Quality Standards and cGMPs for Quality Assurance. Identify, coordinate and implement systems that assure cGMP compliance and continuous improvements. Ensure Quality Assurance disciplines are synchronized in approach, providing continuity between the departments resulting in consistent decision making and superior service. Support the continual advancement of the business processes in Quality Assurance assuring compliance and efficiency. Key in directing the resolution of site compliance issues. Actively involved in creation and improvement of KQIs and develops solutions to enhance data collection, compilation, reporting, and trending. Responsible to meet objectives while managing spending, labor and capital to budget. Mentor and develop staff. Interfaces with Supply Chain Management to ensure product status and dispositions are made visible and support business needs while maintaining compliance. Minimum requirements: Education: Bachelor's Degree required but Advanced degree is preferred. Experience: Required minimum 12 years of professional related experience in quality assurance within a pharmaceutical manufacturing environment and a minimum of 7 years management experience required. Required experience in solid oral dosage forms and communications with Regulatory Authorities (preferred FDA, DEA, EMEA). Experience in Pharmaceutical Manufacturing operations and controls, change management processes, regulatory affairs, validation, leadership, influencing, and negotiation. Experience in lean manufacturing practices and quality control a plus. Additional Competencies: Required knowledge of global GxP regulations Excellent communication, collaboration and team building skills. Required skills: verbal/written communication, negotiation/influencing, leadership, risk assessment Basic Computer Skills: MS Word, MS Excel, MS PowerPoint, Adobe Acrobat, ability to learn data entry into various databases Required years of experience: Above Ten Years
	Location  Consultant  Phil Ellis
Manager, Product Release
	Company - small and growing fast. Located in S. Florida between Ft. Lauderdale & Miami. Company produces transdermal patches, so we need pharmaceutical experience. Transdermal experience would be a plus. Responsible for managing all activities related to batch record review and product release, raw material and component release to ensure compliance with regulatory requirements, client agreements, and company policies. Bachelor’s degree with 5-7 years experience, or equivalent combination of education and experience. Experience must be in management of staff of Quality systems including product release in a commercial environment in the pharmaceutical industry.
	Location  South Florida Consultant  Lee Douglas
Associate Director / Director, Quality Assurance
	Associate Director / Director of Quality Assurance - RTP, NC location Parenterals manufacturing facility located near RTP, NC seeks an Associate Director / Director of Quality Assurance. This will be the senior Quality officer for the facility, reporting to a VP Quality who is at another location. BS minimum, advanced degree and certifications preferred. Must have experience in Quality Management in an aseptic fill (SVP) operation. Competitive compensation including base, bonus, relocation if needed.
	Location  Raleigh, NC Consultant  Lee Douglas
Post Market Investigator III (exempt)
	Company - small and growing fast. Located in S. Florida between Ft. Lauderdale & Miami. Company produces transdermal patches, so we need pharmaceutical experience. Transdermal experience would be a plus. Under limited supervision, this position completes product quality investigations as it relates to customer complaints and adverse events reported to the Post Market Compliance Department.  The Post Market Investigator position requires the ability to handle variety of tasks, meet timelines, and maintain cross-functional interactions with laboratory, quality assurance, engineering and production departments as well as marketing clients. Bachelor’s degree and 3-5 years experience, Associate’s Degree or technical school and 5-7 years of experience, or high school diploma or equivalent and 7-9 years of experience. Experience must be in quality systems, preferably customer complaints in the pharmaceutical industry.
	Location  South Florida Consultant  Lee Douglas
QA Compliance Auditor
	Job Description Travels to domestic and international manufacturers of raw materials to perform Quality System audits using cGMPs, sanitation programs, and housekeeping inspections; inspects manufacturing, packaging, warehouses, labs, and other supporting departments. Reports audit findings to QA Director and publishes written audit findings. Prepares a list of approved vendors based on inspections. Creates corrective action plans, and assists vendors in implementing until completion date. Job Requirements Science based Bachelors degree (food science, biology, microbiology, chemistry, other), or equivalent experience plus three+ years of experience in Dietary supplement/Pharmaceutical environment. External or supplier auditing experience preferred. Applicable certifications (i.e. ASQ CQA) desirable.
	Location  SC Consultant  Lee Douglas
Regulatory Affairs and Clinical Affairs
Regulatory Affairs Specialist III
	NC Pharma Company. SUMMARY: Reporting to the Director or Manager of Regulatory Affairs, this position will focus on providing Regulatory Support of our VAPPs portfolio including; dietary supplements, Rx, Generic and Proprietary Pharmaceutical (Life Cycle Management) Development efforts. The position will work closely with Product Development scientists, and is responsible for the planning, preparation, submission and lifecycle management of US and Canadian product registrations and related submissions/documentation including annual reports and periodic adverse drug experience reports. The RA Specialist III assists in the development and implementation of regulatory strategy for assigned projects and represents RA on assigned project teams. Another key responsibility is to support the Change Review Board and provide an assessment concerning the regulatory impact of a change for supplements to approved applications (i.e. prior approval, CBE 30, etc.). The RA Specialist III will also provide the CRB with the type of data necessary to successfully support the proposed change. Bachelor of Science or Bachelor of Arts Degree in a scientific related field is preferred, or a four year degree from an accredited organization with a minimum of 8-10 years experience in Regulatory Affairs or related equivalent experience. Regulatory Affairs Certification (RAC) strongly preferred. Demonstrated ability to manage multiple projects and work independently with minimal supervision.
	Location  NC Consultant  Lee Douglas
Manager, Documentation and Regulatory Affairs
	Job Description Responsible for the computerization filing of all documents for raw material databases and finished product databases with technical support for regulatory approval and specification approval which support the manufacturing, product development, and Quality functions. These include but are not limited to: MAPICS (master formulas, new and changes), manufacturing directions, bulk specifications, raw material specifications. BS/BA (minimum in Chemistry, Biochemistry, Pharmacology, Biology, or other science related degree). At least 5 years in quality assurance in laboratory or regulatory positions in a dietary supplement company. Knowledge of dietary raw materials and dietary supplements. Knowledge of the cGMPs for dietary supplements (21CFR Part 111) and some knowledge of cGMPs for drugs (21CFR Part 211). Advanced degree preferred in a science discipline.
	Location  SC Consultant  Lee Douglas
Director, Drug Safety
	Job Description The Director of Drug Safety will provide strategic and tactical direction for the US Drug Safety team (Pharmacovigilance, Drug Information, and Complaint organization). This position will provide medical leadership for US Drug Safety strategy and assure the core job functions of the Medical Affairs Department are executed in a manner that meets internal and external customer expectations. The position is responsible for developing and implementing operational and strategic policies and directives, directing the activities of resources, both internal and outside contractors/vendors. Provide oversight of team to ensure there is appropriate medical input and review to support relevant clinical development, business development, market research, marketing and corporate communication, and sales/marketing promotional material/activities. This position serves as primary liaison with regulatory authorities in matters of Drug Safety and will report to the Vice President of Quality Management. Location - Colorado. Must have PharmD, or MD. Must have minimum 8 years of experience in the biotech or pharmaceutical industry, in drug safety, clinical practice including Key Opinion Leader management, medical education programs, pharmacovigilance, sales force training and support, clinical development.
	Location  Colorado Consultant  Lee Douglas
Research & Development
DIRECTOR, R&D
	The DIRECTOR, R&D is responsible to the VP, R&D for leading the company's product development group in conceiving, developing, scaling up and transfer of new drug delivery technologies. Will lead and supervise the planning and implementing the activities of cross functional teams towards meeting the milestones of the company's portfolio objectives. Will provide resident expertise re formulations, colorants, and other raw materials. Insures that all experimental designs, procedures, projects etc. meet all compliance requirements. Will identify and lead collabrative R&D opportunities with outside organizations. Will keep upper management advised of project(s) status. Will be responsible for R&D strategic planning. The successful candidate will have a minimum of 8 years experience in R&D/formulations, including significant managemnent experience. A PhD or PharmD in Pharma. Sciences, Chemistry or related discipline is required. The company is Southeastern US based in a quite reasonable COL area with a high quality of life. Competitive compensation and benefits.
	Location  Southeastern USA Consultant  Phil Ellis
Sr. Scientist Formulation
	The main responsibility of the Senior Scientist is research designed to advance company's product leadership goal.   The areas of research will include nanotechnology based formulation development, oral delivery of macromolecules, controlled drug delivery approaches such as gastro-retentive dosage forms and colon targeted dosage forms.  Other areas of research will include bioavailability enhancement, design of dosage forms to decrease food effect and variability, tablet dosage form development for softlet development, and general solubilization technologies.  The main goal of this position is to position company’s formulation development efforts on the cutting edge of product leadership. A Ph.D. in Pharmaceutical or related science with demonstrated experience in drug delivery research (small and large molecules) and/or formulation development as well as cGMPs is required.
	Location  NC Consultant  Lee Douglas
Manager, Project Management
	For this fast-growing pharma company in NC. Manages the Project Management department within R&D to assure progress toward critical milestones of Banner's strategic plan. Ensures the successful planning, development, administration, and execution of the new product development process. This includes identifying company needs, defining scope, estimating labor, technology, and capital resource needs, and measuring and reporting the performance of the project management group. Persons in this position will also directly manage some development projects and provide support of project management processes at other sites.
	Location  NC metro area Consultant  Lee Douglas
Material Scientist
	A Material Scientist in the Formulation Development Group is expected to perform duties typical of a material scientist in a pharmaceutical Product Development laboratory setting. Duties include pharmaceutical excipient characterization (rheology, DSC, particle size and texture analysis), hydrocolloid characterization (gelatin, starch, cellulose, pectin, and carrageenans), softgel drug delivery platform development, benchtop and pilot scale experimental trials, technical report writing, and support of FDA filings. Ph.D. degree in Material Science, Polymer Science, Pharmaceutical Sciences, Chemistry, Chemical Engineering or a related discipline with more than 2 years industry experience.
	Location  NC Consultant  Lee Douglas
SALES and MARKETING
Western Regional Sales Manager
	Profile for ScandiDos Inc. - Western Regional Sales Executive Background: The company is a Scandinavian company that is expanding it's US-based operation for sales and support to the western USA and Canada.The company has developed a unique product used for Quality Assurance in advanced Radiation Therapy. The product has been enthusiastically received on the market. The two leading therapy system vendors, Varian and Elekta, have recognized it as the system for performing QA for their new rotational therapy (RapidArc and VMAT). The product has FDA 510K approval. This is a highly innovative company and offers a creative and stimulating environment for the employees. Job description: The person we are looking for shall identify the on-going projects for purchase of new equipment, the needs for QA and drive the projects to closure. The person must be used to working independently and to plan both on a long term and day-to-day basis. The work tasks include: Survey and analyse the market situation in the territory and identify the prospective business. Develop and implement a strategy to best cover the western North American market.  Develop a network with other companies in the field in order to identify buyers and to bundle systems with other major equipment purchases. Plan and make sales calls contacting prospective buyers. Plan and perform sales on-site demos. Prepare and send out and follow up on quotations to potential buyers. Support customers in application, software and hardware issues. ( We are also currently recruiting for a Customer Service Professional, so this responsibility will diminish when that is done ) Install systems and train customers to use them. ( Ditto above parenthetical statement ) Market the products in the territory Plan for and participate in the trade shows to generate new leads, demonstrate and explain the products to potential customers (ASTRO, AAPM etc.) Generate sales forecasts and timely report to the sales and marketing manager. Maintain market knowledge and trends, proper self-training, participate and contribute to company market and product training and feedback. Job requirements: The person we are seeking will be located in the Western US and shall have: Documented skills in sales in the field of radiotherapy, preferably in software or systems A technical understanding to be able to support customers both in technical and application questions A wide network in the radiotherapy field both with end-users and with the main accelerator and other major equipment in the radiotherapy field Be self-going, structured and able to work as a team member with the main office in Sweden An excellent communicator and able to present complex products to various types of customers Travel at least 100 days per annum.
	Location  West Coast Consultant  Phil Elllis