Openings are listed for the following disciplines:
Engineering and Validation (4) Management (1) Materials / Supply Chain (1) Production / Packaging Management (3) Quality Assurance / Quality Control (6) Regulatory Affairs and Clinical Affairs (3) Research & Development (4)
Engineering and Validation
Director, Maintenance Operations
	Company ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. Opportunity Profile: The Director, Maintenance Operations will lead and manage the Maintenance Department as it meets its mission of providing support in order to add, improve and maintain the Company's facilities, buildings, equipment and grounds. The incumbent in this role will ensure that maintenance work is in compliance with the company's policies and GMPs and will be responsible for managing all controllable spending for the plant. The incumbent in this role will: Direct overall maintenance operations for both maintenance of manufacturing equipment and maintenance of all Company's facilities. This includes allocating staff resources, scheduling maintenance projects, assign resources to projects and provide maintenance project updates. Coordinate, monitor, evaluate and direct workers and contractors engaged in performing structural, mechanical, electrical and electronics repairs, preventative maintenance to buildings, equipment, systems and grounds to assure conformance to specifications, standards and budget constraints. Maintain Enterprise Asset Management (EAM). Maintain history and cost of all equipment, systems, and spare parts inventory and supply cage. Impact of incumbent's decisions on assets is significant. Lead Maintenance Operations budget preparation including forecast of small tools, machine parts, building and facility improvements. Assist direct reports with short and long term planning including future resources required. Manage the team and provide day-to-day guidance for staff. Train, mentor and provide development opportunities for direct reports and indirect reports. Ensure maintenance work is completed on time, to accepted standards and meets GMP requirements. Ensure safety regulations are observed. Support production, R&D and laboratories in maintenance and problem solving. Establish and/or adjust work procedures to meet production schedules. Analyze and resolve work problems or assist staff in solving work problems. Assist with job posting and interviews. Hire candidate(s) for openings. Arrange training for new hires. Motivate workers to achieve work goals by fostering their ideas and by initiating or suggesting other ideas. Analyze and resolve work problems or assist workers in solving work problems. Qualifications: A Bachelors degree in Engineering and five years of experience is required. Ten (10) years of experience working in facilities maintenance, engineering, or construction, with supervision of maintenance operations, is preferred. Extensive experience in both maintenance and construction is required. However, a combination of experience and/or education will be taken into consideration. Candidates must have expert level knowledge of engineering concepts and facilities systems, equipment, utilities, SOPs and cGMPs and strong problem solving, people and project management skills. Must possess interpersonal, communication, management, and computer skills and have the ability to think logically and creatively and have solid communication, writing and financial skills. Must possess computer skills and knowledge of AUTOCAD, Excel, Word, Microsoft Project, Lotus Notes and SAP. We are not satisfied with anything less than being the best. As one of the world's leading generics and specialty pharmaceutical companies, the key to our success starts with a relentless drive to set the highest industry standards in everything we do. It takes exceptional people working together to achieve excellence. As a team, we earn our customers trust and loyalty by placing a high premium on always doing the right things in the right way.
	Location  WV Consultant  Phil Elllis
Sr. Process / Project Engineer
	Sr. Process/Project Engineer NC Based Pharmaceutical company is seeking an individual who will be responsible for various activities in support of process optimization including collaborating with R&D to develop innovative production processes with a special focus on quality by design and planning and executing capital projects for new equipment technologies and systems. This individual will: 1.) analyze, develop, and recommend equipment and methods to meet production requirements for new or improved products and processes 2.) Develop and implement best manufacturing practices and technologies for the scale up of manufacturing processes from R&D to commercial Manufacturing 3.)Recommend and implement equipment and process changes to improve quality and reduce costs by providing technical analysis and input. Required is a BS in an Engineering field with 6 years experience in the pharmaceutical industry. Preferably in a liquid or semi-solid facility.
	Location  NC Consultant  Tina Skidmore
Calibration Supervisor
	Calibration Supervisor Primary Objective of Position Plans, organizes, leads and controls all aspects of the calibration function on site. Acts as primary interface between Facilities Department and other department on calibration matters.Supervises calibration and instrument maintenance contracts. Major Duties/Responsibilities Plans and organizes required calibrations and maintenance. Implements creation of calibration and maintenance records as required by Site SOPs. Reviews and approves calibration and maintenance reports as required by Site SOPs. Develops procedures to ensure compliance with required calibration and maintenance standards. Acts as primary interface between Facilities Department and other departments on calibration matters Plans, negotiates and manages execution of process and analytical equipment calibration contracts. Reviews and approves specifications for new instruments and analytical equipment Plans, organizes and executes projects related to field of expertise Ongoing professional development in field of expertise. Minimum Job Qualifications Describe the minimum job-related qualifications required to perform this job in a satisfactory manner. Education Bachelors degree in related engineering or science discipline. Experience Ten (10) or more years working experience in a pharmaceutical manufacturing / QC / R&D environment. Five (5) or more years experience in calibration and maintenance of pharmaceutical manufacturing / QC / R&D equipment instrumentation. Special Training Documented training in fundamentals of calibration Documented training in fundamentals of cGMP Minimum 3 years supervisory experience required
	Location  GA Consultant  Tina Skidmore
Principal Project Engineer
	Overall Job Summary: Provide engineering skills and coordination of the medications, troubleshooting and improvement of major process systems and facility improvements. Coordinate and manage the design and construction of all engineering projects for Fort Worth Manufacturing. Author and execute validation IOQ protocols, evaluate and submit the reports for approval. Minimum Education Requirements: BS Degree in Chemical, Electrical or Mechanical Engineering Minimum Experience Requirements: 9 years related experience
	Location  TX Consultant  Lee Douglas
Management
Technical Operations Manager
	Formulations and technical operations position for this NC company. The Technical Operations Manager directs and oversees the policies, objectives, schedules, and initiatives of the Technical Operations department. The position requires maintaining the companies' competitive position and profitability by formulating research and development programs. Tasks include both supervisory and direct laboratory work. A minimum of 5 years of relevant experience is requires in the field of product and process development. A familiarity with a wide variety of concepts, practices, and procedures in the Process Development of Nutraceutical products, as well as those of CGMP Manufacturing and other related departments is necessary. Must rely on extensive experience and judgment to plan and accomplish goals. Reports to the Director of Manufacturing.
	Location  NC Consultant  Lee Douglas
Materials / Supply Chain
Director, Materials Management
	Position Summary: Leadership of Materials Management functional teams (Warehouse, Planning and Purchasing) at the Ohio Manufacturing Facility. Responsible for planning, integration and collaboration with Corporate Materials Management and Alliance Partner functions and processes.Integration of industry compliance requirements with efficient and customer-oriented business processes. Defining, monitoring, and improving on team performance metrics. Resonsibilities: Build, sustain and maintain production and materials planning policies and operational procedures. Engage in supplier negotiations, contract management, procurement and vendor management for site specific materials. Provide direction and support in the development and implementation of new solutions, or strategic and tactical plans that improve systems capabilities to enable more robust planning, inventory control and reporting. Develop department strategies and policies and oversee their implementation, ensuring proper execution. Warehouse and materials management and planning for entire manufacturing site and material flow throughout. Oversight of proper solvent receipts and tank farm operations as well as waste and hazardous waste management. Continuous improvement efforts employing both Six Sigma and Lean methodologies. Partner with Quality Assurance, Manufacturing, and internal customers to coordinate and plan activities including ensuring resolution and continuous improvement. Lead in evaluating and implementing new technologies for warehouse systems. Comply with cGMPs, regulations and guidelines, company policies and department SOPs. Annual budget development and management for department. Requirements: Bachelors Degree required. APICS certification preferred. 15 years of experience in related industry. Must have experience in Materials management inventory control, and ERP/MRP systems (JDE, SAP). Pharmaceutical or regulated industry experience strongly preferred. Ability to lead people, set priorities and balance strategy and tactical. Must be flexible and have the ability to succeed in a fast-paced environment. Effective communication skills both written and verbal. Perform function with little guidance. Ability to work long hours as needed. Position required the ability to travel up to 20% of the time both domestic and international. Must be able to use a computer.
	Location  OH Consultant  Lee Douglas
Production / Packaging Management
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: 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. 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. 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. 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. 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
Production Supervisor
	SUMMARY: Maintain daily department operations and meeting production plans while achieving quality and cost objectives. Provide leadership to a skilled labor force engaged in manufacturing activities to maximize the utilization of material, equipment and human resources. Work closely and coordinate with Planning, Purchasing, Warehouse, Quality Assurance, Engineering, Finance and Human Resources to achieve corporate goals. ESSENTIAL DUTIES AND RESPONSIBILITIES: Communicate job expectations; planning, monitoring, and appraising job results; coaching, counseling, and disciplining employees; initiating, coordinating, and enforcing systems, policies, and procedures. Maintains staff by recruiting, selecting, orienting, and training employees; developing personal growth opportunities. Maintains work flow by monitoring steps of the process; setting processing variables; observing control points and equipment; monitoring personnel and resources; studying methods; implementing cost reductions; developing reporting procedures and systems; facilitating corrections to malfunctions within process control points; initiating and fostering a spirit of cooperation within and between departments. Completes production plan by managing personnel; accomplishing work results; establishing priorities; monitoring progress; revising schedules; resolving problems; reporting results of the processing flow on shift production summaries. Maintains quality service by establishing and enforcing organization and cGMP regulation standards. Works with R&D, QA, and Maintenance to ensure standards are documented, maintained and meet all Regulatory compliance needs Ensures operation of equipment by placing work tickets for repairs and coordination with Maintenance; evaluating new equipment and techniques. Provides manufacturing information by compiling, initiating, sorting, and analyzing production performance records and data; answering questions and responding to requests. Creates and revises systems, batch paperwork, and procedures by analyzing operating practices, record-keeping systems, forms of control, and budgetary and personnel requirements; implementing change and improvements. Audits operations by reviewing all log documentation, daily batch records for complete entries and correct information. Maintains safe and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources; maintaining compliance with established policies and procedures. Resolves personnel problems by analyzing data; investigating issues; identifying solutions; recommending action, and implementation of corrective actions. Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices. Contributes to team effort by accomplishing related results as needed. 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION AND EXPERIENCE: Four year degree required, preferably in Engineering or related field, including 2 years of leadership responsibilities are required. Knowledge of Lean Six Sigma and 5s principles with Pharmaceutical experience is preferred. LANGUAGE SKILLS: Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Ability to effectively present information in one-on-one and small group situations to employees. This includes communicating procedures, directions, guidelines, etc. Ability to understand and implement management directives. REASONING ABILITY: Ability to define problems, collects data, establishes facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram forms and deals with several abstract and concrete variables. OTHER SKILLS AND ABILITIES: Ability to use a personal computer with a high level of MS Office Applications including Excel and Access. The person should also have excellent verbal and written communication skills. SPECIAL REQUIREMENTS: Must meet applicable DEA security clearance requirements. PHYSICAL DEMANDS: Occasional sitting. Frequent standing, walking, climbing/balancing, stooping (to include kneeling, crawling, and crouching), and talking. Continuous reaching with hands/arms and using hands to finger, handle, or feel. The ability to lift weight and/or exert force of up to 100 pounds is also required. Heaviest exertion occurs when moving gelatin tanks. Close vision, distance vision, color vision, peripheral vision, and depth perception are required. WORK ENVIRONMENT: Frequent exposure to wet or humid conditions, working near moving mechanical parts, and exposure to fumes or airborne particles. The noise level is moderate. PERSONAL PROTECTIVE EQUIPMENT: Safety glasses, gloves, lab coats, safety shoes, dust masks, and covers for hair and facial hair.
	Location  NC Consultant  Phil Elllis
Quality Assurance / Quality Control
VP Quality
	This position is directly responsible to develop, implement, oversee and maintain a Quality System and Compliance Strategy that is reflective of the global corporate business model for the company. Position is responsible for the leadership, development, and operational oversight of a large and diverse organization operating in a complex environment. ESSENTIAL DUTIES AND RESPONSIBILITIES To perform this job successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. 1. Develop, implement and maintain a Quality System and Compliance Strategy for the company that reflects the regulatory expectations, business model and objectives. 2. Specifically ensure that the following activities are conducted by appropriate personnel: a.Approve or reject components, drug product container/closures and drug product b.Approve or reject specifications, sampling plans, test methods, master batch records and other relevant quality procedures and/or documents c.Necessary testing is conducted, reviewed and approved d.Appropriate investigations are conducted when necessary e.Appropriate validation activities are conducted f.Appropriate training is conducted g.Evaluation of relevant component suppliers and appropriate contract service providers 3. Define and ensure successful execution of operational goals and objectives for the Quality Unit that are in line with the regulatory expectations, business model and strategy/ goals for the company. 4. Manage an extremely large team of quality professionals and coordinate oversight activities to support a vast product line with significant complex formulations. 5. Develop appropriate metrics programs as necessary to evaluate quality, compliance or budgetary strategies/ goals. 6. Report metrics to relevant management groups to demonstrate adherence to relevant strategies or goals. 7. Interact, as required and necessary, with the offices of North American and/or Global Quality or other groups within the company. 8. Ensure timely, efficient and effective communication and/or inspectional interaction with regulatory authorities as necessary. 9. Ensure timely, efficient and effective communication and/or interaction with internal GxP partners or external contract organizations. 10. Monitor industry trends and regulatory expectations to ensure appropriate evolution of the Quality System and Compliance Strategy. 11. Coordinate development of a fiscally responsible budget and headcount strategy for the Quality Unit and monitor performance of both elements. 12. Perform other duties as assigned. QUALIFICATIONS The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required. KNOWLEDGE Must possess knowledge of GXPs, DEA and EU guidelines. SKILLS AND ABILITIES Must possess excellent writing and communication skills and reading and interpretation skills. Must possess strong leadership and management skills. Must demonstrate excellent time management skills. Must possess computer skills and a working knowledge of Microsoft Office Suite and Lotus Notes. SUPERVISION Position reports to North America Head of Quality. There are currently nine (9) direct reports to this position. The position acts as a resource to the organization. Position functions autonomously. EDUCATION/EXPERIENCE 10-15 years of experience working in the Pharmaceutical Industry. Bachelor of Science/Arts degree in scientific field, minimum required. LICENSES/CERTIFICATIONS None Required LANGUAGE SKILLS Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence.Ability to work with managers or directors and communicate ambiguous concepts. Ability to present to groups across the organization. SCIENCE/MATHEMATICAL SKILLS Advanced math, including algebra and statistics, required for the position. Knowledge of chemistry and pharmaceutical science required. REASONING ABILITY Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems. Make decisions that affect the financial well-being of the company. Erroneous decisions or recommendations would result in failure to achieve major goals and objectives of the organization. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties. Typically sitting at a desk or table. Typically standing and/or walking. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties. Normal office situation with time spent in product facilities and laboratories. Work closely with others.
	Location  WV Consultant  Phil Elllis
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
VP Quality - Transdermals
	Develop and implement strategies and programs to provide, assurance of the site's compliance with NDA/ANDA, cGMPs, and other FDA and other relevant regulatory authority for countries where company products are distributed. The following are among the job expectations: requirements, maintenance of adequate and qualified staff, improvement of work processes, identification and communication of critical and potentially critical regulatory and quality issues, and keeping senior management informed of issue and program status.Responsible for all written and oral communication with local FDA District (inspectional/compliance) issues. Performs job functions in accordance with the Occupational Safety and Health Administration (OSHA) guidelines. Ensures compliance with Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations and Current Good Manufacturing Practices (cGMPs). ESSENTIAL DUTIES AND RESPONSIBILITIES To perform this job successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. 1. Provide organizational leadership and senior management oversight to the Quality departments. Keep senior management informed of program status and development on critical issues. 2. Provide site leadership consistent with that of a senior site executive providing a balanced perspective on issues relating to the VT site and representing the site and its issues to the North America Leadership Team as appropriate. 3. Insure Quality system integrity, and complete timely investigations of testing issues. Manage regulatory, and customer audits and insure resolution of observations, and identified corrective and preventative action. 4. Identify staffing needs, provide justification, obtain approval, and recruit qualified personnel. Coach and develop staff. 5. Review and critique documents intended for regulatory submission. Review systems and procedures, add, modify, and streamline as appropriate. 6.Provide forums for obtaining relevant input and resolving, quality, and compliance issues. 7. Assist the General Manager with project management. 8.Insure timely communication of Quality issues to Sr. Corporate Management 9. Perform other duties as assigned. QUALIFICATIONS The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required. KNOWLEDGE Must possess knowledge of Quality Systems and direct experience leading and managing Quality related functions within the pharmaceutical industry including at least 5 years with management responsibility in quality affairs. Must have technical understanding of pharmaceutical product formulations, and pharmaceutical unit operations. Must understand and adhere to Company and departmental policies and procedures as well as government regulations. Must adhere to Company and Department policies and procedures as well as government regulations. Requires understanding of Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations and Current Good Manufacturing Practices (cGMPs). SKILLS AND ABILITIES Must possess good leadership, management, communication, time management, organizational, interpersonal, and writing skills, and computer skills including Microsoft Word and Excel and Lotus Notes. SUPERVISION Position functions autonomously. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. EDUCATION/EXPERIENCE Minimum of a Bachelor's degree and 10 years of experience in Pharmaceutical Product Development, Pharmaceutical Regulatory and/or Pharmaceutical Quality functions is required. However, a combination of experience and/or education will be taken into consideration. LICENSES/CERTIFICATIONS None required. LANGUAGE SKILLS Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization. MATHEMATICAL SKILLS Ability to add, subtract, multiply and divide, compute statistics, ratios and percents; compute rates and probabilities. REASONING ABILITY Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties. Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. Periodic travel is required. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Sedentary lifting requirements. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties. Normal office situation. Exposure to manufacturing and laboratory environments.
	Location  VT Consultant  Lee Douglas
Director, Quality
	POSITION SUMMARY This department will have the overall responsibility for the physical plant (land, building and equipment), project and process engineering, capital project execution, and Employee Health and Safety. The department will closely interface with the General Manager to ensure strategic growth and new technology initiatives, are well planned and efficiently executed. Overall responsibility for the management and supervision of all facilities and engineering activities that supporting sterile manufacturing at the North Raleigh site. This includes, but not limited to the areas of EH&S, building utilities, manufacturing technical support, capital construction and grounds building maintenance, as well as process engineering. The senior manager will supervise activities of managers responsible for all related functional areas and ensure the highest quality standards and regulatory compliance by performing the following duties personally or through subordinate supervisors. PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT Strategic customer contact (requires excellent communication skills, both written and verbal). Work with business partners to ensure they understand technology options and evaluate alternative technologies in light of company capabilities. Strategically plan projects, resources and priorities to meet corporate and site goals and ensure customer specific projects are completed on time. Responsible for the financial accountability of all groups assigned. Direct subordinates in efficient finical processes and procedures in alignment with fiscal year profit plans. Provide appropriate training and mentoring to subordinates staff. Continuously updates self and all subordinates on current regulatory and technology best practices and ensures all associated group apply knowledge gained using appropriate change control processes. Modifies existing or generates new SOP as needed. Represents all facility-related departments during customer or regulatory agency relate audits. Coordinates with General Manager and company leadership to create and periodically update a site strategic growth plan that ensures capacity is available to meet customer needs. Identify and incorporate new industry technology trends to anticipate shifts in market demands. Will serve as a technical expert to other company sites and participate in strategic technology assessments with senior company management staff. REQUIREMENTS At least 20 years of broad-based technical management in a sterile pharmaceutical manufacturing environment, preferably with exposure to lyophilization, barrier/isolator technology and pre-filled syringe processing. Business experience, including minimum of 10 years in technical management within the pharmaceutical industry, preferably involving engineering, facility and manufacturing responsibility. Demonstrated positive results in progressive positions of authority, including a record of success in a cGMP sterile manufacturing environment.
	Location  NC Consultant  Tina Skidmore
Director, Laboratory Operations
	Dir, Laboratory Operations Job Description . Manages, plans, and directs the activities of the Laboratory Operations departments for products related to routine production, stability, complaints, to site transfer products, alternate vendor approval, validation protocols and methods validation by performing the following duties personally or through subordinate staff support. • Provides managerial support, direction and coaching to subordinates; maintains departmental employee recruitment, selection, training, development, safety, promotion and retention levels to ensure proper and effective staffing. This position is responsible for over 100 direct and indirect staff members. • Provides assistance to the Site Head of Quality; prepares and presents staff reports and other necessary correspondence. • Directs the work activities of analytical testing groups to assure product and components comply with specifications; and reviews, evaluates/modifies, as needed, test methods and procedures. • Reviews and approves all OOS Investigations. • Reviews and prepares annual budget for assigned areas of responsibility in the Laboratory Operations department. • Reviews and approves new and revised Standard Operating Procedures (SOPs) and other laboratory documents. • Directs the work activities of the Training and Reviewing group to assure that all documentation is complete and accurate and that new employees are properly trained. Qualifications Qualified applicants will have strong leadership experience and abilities, having successfully managed large lab operations in a pharmaceutical, food, cosmetic or related industry. Pharmaceutical experience is preferred. The ability to influence vertically and horizontally across the organization is essential. Also required is a background in GMPs and Operational Excellence/Lean/Six Sigma and experience with HPLC, GC and LIMS. The applicant we hire will be a high energy, can-do, adaptable individual who thrives in an action oriented environment Education and Experience Bachelors Degree in Chemistry, Pharmaceutical Science or related field from an accredited college or university and a minimum of eight (8) to ten (10) years of progressive management experience; preferably in the pharmaceutical industry.
	Location  Florida Consultant  Lee Douglas
QA Manager
	SUMMARY: Oversight of some or all of the Quality Assurance groups to include QA Line Inspection. QA Documentation Control, QA Batch Review and Release and the Product Analysts. This position is delegated the responsibilities and authorities of the Quality Systems Director, in the Director's absence. This position has one or more of the QA Supervisors, Product Analysts and the QA Systems Analyst reporting directly to them. This position has responsibility for ensuring Quality Assurance oversight of the various company GMP facilities, ensuring compliance with FDA and EU GMP standards with regard to control of facilities, personnel, processes and materials. ESSENTIAL DUTIES AND RESPONSIBILITIES: Include the following. Other duties may be assigned. 1.Manages the activities of the Line Inspection Supervisor, Review and Release Supervisor, Documentation Control Supervisor, Products Analysts and/or the Quality Systems Analyst 2.Provides QA management review and approval of deviations, complaints, change controls, qualification/validation documents and system reports. 3.Manages departmental costs to assure compliance with the approved budget and in conjunction with the Director, identifies/justifies the need for variances from the budget. 4.Manages Quality Systems for the site providing reporting, guidance, training and modification to the systems as necessary in order to meet compliance and business needs. 5.Personnel development of supervisors and analysts, setting goals and objectives for supervisors and direct reports. 6.Attends or facilitates meetings in support of the Quality initiatives. Provides coverage in the absence of the Quality Systems Director 7.Supports Client and Regulatory audits and inspections either directly or indirectly as necessary. 8.Provides QA oversight of the GMP facilities ensuring compliance with FDA and EU GMP standards with regard to control of facilities, personnel, processes and materials. Note: Within my areas of responsibility, understand and comply with all DFB Pharmaceuticals, Inc. safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations. SUPERVISORY RESPONSIBILITIES: Directly supervises employees in the Quality Assurance Department. Carries out responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. 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. Individual must have basic knowledge of the following areas or fields: validation, chemistry, microbiology, and regulatory affairs. Working knowledge of the cGMPs, manufacturing equipment and proficiency in MS Office is a must. The candidate must also have management, technical writing, problem solving, interpersonal and communication skills. EDUCATION and/or EXPERIENCE: Bachelor's degree with at least 6-9 years of experience in Quality Assurance and Quality Control within a pharmaceutical or manufacturing industry or related field. LANGUAGE: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conforms to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors. MATHEMATICAL SKILLS: Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. 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. REASONING ABILITY: 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, musical notes, etc.,) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables. 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 this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to talk or hear. The employee is occasionally required to stand, walk, and sit. Specific vision abilities required by this job include close vision, and distance vision. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
	Location  TX Consultant  Phil Elllis
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
Managing Director
	Responsible for leading all site activities, including resulting P&L performance. Manage facility performance in areas of safety, cost, quality and service. Responsible to ensure that execution of the business plan is done so in compliance with all FDA, DEA, OSHA and EPA regulations. Direct reporting lines to include Scientific Affairs and Analytical Development. Indirect reporting lines include Regulatory, Supply Chain, Technical Services, IT, Global Compliance, Portfolio Management, Human Resources and Finance and Accounting. Directs the design and development of liquid and semi-solid formulations including oral and topical solutions, suspensions, and emulsions, nasal sprays, inhalation products, creams, ointments and suppository formulations. Acts as an R&D representative on sourcing, product portfolio and other divisional committees. Participates in the development of physical and in-vitro test procedures, stability protocols and regulatory documentation including CPSC, ANDA and supplemental submissions. As site head, works closely with the Analytical and Process Development and Regulatory departments to coordinate activities and prepare registration submissions and responses. Directs and supervises the formulation development groups, the analytical development team, and prepares QA technology transfer, reports and documentation for the Chemistry-Manufacturing-Controls section of registration submissions. Assists in troubleshooting formulation related issues associated with regulatory submissions, Quality Assurance and Manufacturing. Directs the design and development of products identified for inclusion in the development portfolio. Establishes SOPs according to scientific and regulatory standards and requirements. Writes and/or approves reports for registration submissions. Establishes preliminary product specifications utilizing appropriate statistical methods and models. Prepares or directs the preparation of appropriate sections of the Chemistry-Manufacturing-Controls section of an ANDA or other registration documents. Assists in the troubleshooting of manufacturing/formulation related problems for products in development and at the post-marketing stage. Maintains state-of-the-art knowledge of manufacturing methodology and formulation related instrumentation. Researches and recommends the purchase of scientific equipment and instrumentation. Establishes and implements procedures for the transfer of technology to the Quality Control department and Manufacturing. Hire, train and mentor junior staff members and supervise accordingly. Participate in and lead project teams and mentor junior staff as project leaders to the timely completion of strategically important projects. Acts as an R&D liaison with Purchasing in the identification and qualification of API and inert ingredient and components. Participate in API sourcing activities and patent evaluations. Education/Training/Work Experience Ph.D. with a minimum of 10 years of industrial hands-on experience in the areas of responsibility. Five years experience at the manager level or above is a prerequisite for this job. Experience developed through the product development ranks exhibiting a solid theoretical knowledge and understanding of basic principles as they apply to the dosage forms of interest to company. Specialized Knowledge and Skills Has experience with the successful design of liquid and semi-solid products; the conduct of product evaluation methodology, the design and implementation of stability protocols, technology transfer, a full understanding of FDA regulations and requirements and the ability to apply statistical models for the establishment of product specifications. A good understanding of analytical development and validation of analytical methods is required. Exhibits a full understanding and ability to troubleshoot manufacturing related formulations problems and analytical problems. Management skills include the ability to lead, direct and motivate a staff of skilled professionals, including Ph.D.s; hire, train and mentor staff and be a well organized self-starter capable of scheduling and conducting a multitude of activities, at times under pressure. A track record of scientific publications and previous experience in the generic segment is viewed in a positive light. Verbal and written communication skills and interpersonal skills are essential.
	Location  MD Consultant  Phil Elllis
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. Director, Solid Oral Dose R$D
	Senior Director, Solid Oral Dose Development Basic Purpose: This position will provide leadership and strategic direction to a group of formulation and process scientists. The position has day-to-day responsibility for all aspects of formulation development of oral solid dosage forms, scale-up and manufacture of ANDA exhibit batches In addition act as mentor to Development Teams providing guidance and advice on all project activities. Functions and Responsibilities: Manage, review, and prioritize the activities of formulation and process scientists engaged in the active development of 25+ product projects, primarily solid oral, modified release, generic drugs Monitor projects to ensure they are consistent with regulatory requirements, company policies, and industry standards. Ensure the compliance and successful completion of each project Provide strong technical and scientific leadership to the development teams, and in particular to the formulation and process groups. Ensure the development of robust formulations and manufacturing processes to provide smooth scale-up and commercial manufacture of products developed Provide advice in the areas of Product Development strategies, legal assessments and review, and competitive evaluations. Actively participate in Portfolio Management groups as required Provide technical support for scale-up, commercial product launch, and post launch issues Advise on resource allocation of staff and budget within the formulation and process group Represent the company to FDA, trade groups, and at scientific conferences are required. Provide scientific training and education to the staff to ensure continued development Education / Training / Work Experience: Ph.D. in a Chemical Science required A minimum of 10 years of solid oral product development experience, experience in the Generic Industry preferred Specialized Knowledge and Skills: The candidate should have a track record of leadership in the development of modified release solid oral dosage forms Previous development experience with fluid bed based manufacturing technology preferred A track record that demonstrates an understanding of the need for meeting time critical deadlines in generic drug development Must have well developed leadership skills, and the ability to develop people. Demonstrated track record of successful leadership and direction across the multi-functional areas that impact product development Must have excellent written and oral communication skills
	Location  NJ Consultant  Lee Douglas
Sr. / Prinicpal Scientist (Assoc Dir) CMC
	Sr. Scientist/Principal Scientist, BioPharm Develop (Cambridge, MA) *Principal Scientist is equivalent to Associate Director within company's org chart BROAD FUNCTION: Lead and orchestrate Analytical Development (AD) efforts to support company-wide CMC activities for new biopharmaceutical development and commercial drug product. KEY RESPONSIBILITIES AND TASKS: •Serve as AD representative to CMC project teams for biomolecule development programs; •Author analytical CMC sections for regulatory filings, documents, and responses; •Manage timelines, priorities, and deliverables within AD; •Lead efforts to define product quality targets, product risk assessment and propose product specifications through collaboration with other AD groups, Quality and CMC team members; •Coordinate activities between AD, other departments and external contractors to develop, qualify, and validate analytical methods; to characterize drug substances/products; to evaluate drug substance comparability; and to perform testing in support of process and formulation development, manufacturing studies, and preclinical studies; •Represent AD CMC activities to partners, external collaborators, and contractors. CONTACTS: CMC Team Leaders and Members; Quality (especially Product Quality Management and Technical Support group), Regulatory, BioPharmaceutical Development, Protein Formulation Development, Protein Product Development, Manufacturing Science, Manufacturing. Qualifications 8 or more years experience in analytical method development, characterization of proteins and program management in the biotechnology or pharmaceutical industry. Familiarity with physicochemical, immunochemical, and/or biological test methods; Demonstrated ability in generating high quality scientific documents, including SOPs, validation protocols and reports, characterization reports, and method development reports; Demonstrated ability in collaborating with other experts in a cross-disciplinary team setting; Computer literacy, mathematical ability, and organizational/time management skills. Education Ph.D. or equivalent in chemistry, biochemistry, or biology.
	Location  MA or NC Consultant  Lee Douglas