| Engineering and Validation | |
| Computer Validation Engineer | |
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For this fast growing, multi-national pharma company located in a highly desirable area of NC. Required are a BS and at least 5 years validation experience in the pharmaceutical industry, to include at least several years of computer validation experience with PLCs, DCS, etc.
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| SENIOR PROCESS DEVELOPMENT ENGINEER | |
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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 cGMP’s and validation processes. Process automation and control experience is beneficial.
Location: North Carolina Contact: 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 Contact: Phil Ellis | |
| 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 Contact: Lee Douglas | |
| Materials / Supply Chain | |
| Manager, External Supply Chain | |
| For this major, multi-national pharma company located near Denver, CO.
Job Description : Position Summary:
Education: Bachelor's degree
Effective organizational skills in„« handling multiple priorities and meeting required budget goals and deadlines.
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| Production / Packaging Management | |
| 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 Contact: Phil Ellis | |
| Team Leader (Production Supervisor) | |
| 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. 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.
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| Quality Assurance / Quality Control | |
| Compliance Associate IV | |
| Lead/manage remediation activities and projects conducted by cross-functional matrix teams.
BS Science / Pharmacy and at least 5 years of pharma experience to include some Quality / Compliance / Regulatory experience. | |
| Compliance Director | |
| This position directs resources to assure GMP compliance for suppliers and third party contract service providers by developing and maintaining compliance programs, policies and procedures, and conducting due diligence evaluations. This position is directly responsible for all district FDA contact for third party field alerts and all Sandoz US recalls. This position manages compliance shared services (SQM, field alerts, recalls, corporate procedures) for all US manufacturing sites and third party quality management program for Sandoz US. The position is responsible for establishment of risk based compliance direction for quality related matters; establishment of management communication tools for areas of responsibility; management of compliance department personnel and budget; assuring rapid resolution of quality related matters associated with suppliers and third party partners; and establishment and approval of quality agreements with contract service providers.
BS in Science / Pharmacy and at least 12 years of pharma experience. | |
| 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, CAPA’s, change control APR’s, 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 cGMP’s 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:
1. Required knowledge of global GxP regulations
2. Excellent communication, collaboration and team building skills.
3. Required skills: verbal/written communication, negotiation/influencing, leadership, risk assessment
4. 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 Contact: Phil Ellis | |
| Manager, QC Documentation | |
| Supervises employees responsible for GMP document management, including: SOPs, GMP forms, specifications, methods, labeling masters, tooling drawings, manufacturing and packaging records, and records retention (archives). Manages and reports on improvement initiatives and systems upgrades. Supports the training of users on Quality Systems procedures and processes, including TrackWise processes. Ensures Quality/Compliance standards are maintained for area of scope. Trains and develops staff. Provides leadership for the group through coaching, counseling and open communication. Supervises a group of employees or outside contractors/vendors who have similar technical or functional responsibilities. Requires operational knowledge of area of functional responsibility. Assigns task, reviews work and writes appraisals. Ensures projects are on schedule and within budget. Receives assignments in the form of general objectives with goals and processes defined. Minimum requirements Education/Experience: BS degree required and 8 to 12 years of related experience.
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| Manufacturing QA Manager | |
| For this multi-national pharma company located in RTP, NC.
Summary:
Education or Equivalent:
Experience:
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| QA - Quality Engineer | |
| This position provides Quality Assurance oversight of Manufacturing and Quality Control areas. Provides QA review and approval of new and existing procedures, investigation documentation, and process control documents. Uses trend and investigational data to create value through process improvements and failure reduction activities. The incumbent must act independently to identify failure modes and related process improvements, facilitating teams and working independently to implement required changes. Performs QA technical review for assigned area. Provides final QA approval on all process, cleaning, method validation protocols, reports and discrepancies, change controls, deviations, OOS investigations, complaint investigations, equipment/facilities. Provides first response for Quality and Compliance issues on the manufacturing floor and the laboratories. Provides review and approval of: Deviations, Investigations, and Inquiries; Protocols/Discrepancies(Validation, Equipment, Process, Production); Change Documentation (CCR’s, DCM’s,PAC’s.) Uses data trends to work with operating departments to identify process improvement opportunities.
Drives compliance, efficiency, or process improvement projects.
Lead teams for tracking of quality activities, metrics, CAPA tracking, etc.
Provides backup to Record Review for review/release of production batch records.
May provide QA approval on any of the following: Change Control; Operational Procedures; Deviations; Lab Inquiries/OOS Investigations; Process, cleaning, validation protocols, reports and discrepancies; Process, equipment and facilities qualifications, protocols/reports; Monitoring instruments and procedures.
Interacts closely with Quality Systems, Operations, Technical Services, Supply Chain, and Lab Management to ensure unfavorable trends are identified and resolved. Provides QA representation on Raw Material Issues team ensuring information continuity for incoming quality concerns through Supply Chain to vendors. Acts as lead or participates in internal audits of plant and laboratory operations. Interfaces with internal partners to resolve technical issues and initiate process improvements. Takes initiative to identify and solve technical and procedural deficiencies to improve productivity. Performs other duties as
assigned. Receives little supervision for most assignments. Receives general instructions for non-standard analyses and projects. Data analysis is complex and requires input from multiple sources and innovative problem-solving. Interfaces to negotiate and exchange information with all levels of management.
BS/BA in Chemistry, Engineering or life sciences and 5 years of professional related experience. | |
| QA Director | |
| For this major parenterals company, manage all Quality Assurance activities - inspection, audit, compliance, documentation, etc. Background must include parenterals and management of a QA Function. Exciting company. Competitive compensation. Relocation provided.
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| QA SPECIALIST, R&D | |
| This is a new position for this fast growing NC based pharmaceutical company.
Reporting to the Sr. Manager QA, the QA SPECIALIST, R&D will be responsible for the implementation and maintenance of cGMP compliant systems within the R&D division. This includes but is not limited to Pilot and Process Lab support during the manufacture of the company's pharma products, batch record review and approval, deviation review and approval, and internal lab auditing. Will also review and release raw materials for R&D; provide QA support during clinical and bio-studies of products; assists with customer audits; assists in deviation investigations for R&D; prepares R&D for PAIs; performs audits of contract testing labs.
Requires a degree in one of the sciences and a minimum of 5 years experience in a pharma quality role. | |
| Quality Control Manager | |
| Pharma company located in NJ.
Manage a professionally staffed Chemistry and Microbiology Quality Control Laboratory operating at a three shift capacity. Reports to the Director of Quality Systems. Location: NJ Contact: Lee Douglas | |
| Reliability Engineer | |
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NC Pharma client. Base - market $'s. Maximize plant reliability to maximize site's production capability. Oversee and streamline the preventative maintenance program. Establish a predictive maintenance program based on historical data. Maintain documentation as dictated by regulatory requirements. Assist with troubleshooting equipment, systems and addressing non-conformance issues presented by other departments. Assist with installation and validation of new equipment and systems, including development of associated procedures and training of personnel. Maximize plant reliability for the Production and Technical Services departments. Oversee and supervise the implementation of the existing preventive maintenance (PM) program. Develop and improve program as necessary. Optimize and manage the spare parts inventory. Perform statistical analysis of historical data for the purpose of predicting maintenance requirements. Review systems redundancy (installed and non-installed spares). Establish a predictive maintenance program. Maintain current documentation for equipment and systems. Produce complete lists of set points and process parameters necessary for troubleshooting and for the correct operation of the systems. Work on non-conformance reports and other tasks as required. Interface with QA, QC, Production and Technical Services. Provide equipment and system training and mentoring to Maintenance, Production, QA and other employees as needed. Assist with troubleshooting of electrical, instrumentation and control systems and components (including PLC and software) for the facility and the process equipment. Participate in and, when requested, manage and assume responsibility for implementing new complex instrumentation and control systems, complete with adequate documentation and participation in the validation effort. Supports and meets Departmental, Plant and Corporate HS&E goals. Works in a safe and efficient manner. Additional Competencies: Extensive knowledge of instrumentation and PLC based control systems Good communication, training and mentoring skills Strong organizational skills and ability to manage multiple complex tasks which require attention to detail. Strong record keeping and documentation ability, good technical ability to understand, analyze and implement reliability and functionality of complex technical systems. BS degree required with 8 to 12 years of related experience Mechanical or electrical engineering degree with minimum 10 years of relevant experience, including prior experience in a pharmaceutical environment. Previous experience in instrumentation and controls and reliability engineering a plus. Required years of experience Seven - Ten
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| SENIOR QUALITY ASSOCIATE | |
| An exciting position in a desirable low COL area with a growing company involved in a wide range of pharmaceutical products. Competitive salary and benefits.
The SENIOR QUALITY ASSOCIATE will:
*provide technical leadership and quality oversite for the sterile processing operations in association with specific aspects of quality to insure compliance with all applicable FDA and company regulations;
*will perform compliance assessments, make decisions re: regulatory requirements, write new procedures, and insure adherence to current regulations;
*conduct risk assessments and take appropriate actions during quality system management and oversight activities to insure adequate controls in relation to the level of product quality, safety and business risks;
*provide leadership and team participation related to quality initiatives, compliance improvements, product transfers, and facility expansions;
*perform document reviews and make determinations as to whether work performed meets current proceduresand regulatory expectations.
BS/BA degree in a scientific field ( chemistry, biology, microbiology, or other technical or physical/life science )plus 4 years experiencein pharmaceutical QA with at least 2 years aseptic processing experience. Location: NC Contact: Phil Ellis | |
| Supervisor, Material & Product Testing - 2nd shift | |
| Posting Title Supervisor, Material & Product Testing Work Location United States - North Carolina Job Description ***THIS IS A 2ND SHIFT POSITION*** Position Summary: Support operations by providing analytical testing for materials and products, including data analysis and reporting. Essential Job Functions:
o Oversees the planning, testing, investigation and reporting of all testing within work group to meet and exceed established metrics. Minimum requirements Position Requirements: Education: Minimum requirement of a BS in the sciences; an MS is a plus.
Work Experience: Minimum of 8 years of professional related experience or 6 years with a MS.
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| 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.
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| Sr. Manager, Clinical Operations | |
| Responsible for the management of the clinical monitoring process, administration and orchestration of clinical and laboratory study related activities, and oversee compliance of NPD to SOPs, GCP/GLP/GMP practices and FDA regulations.
The position has 6 major areas of function: Minimum requirements Graduate degree in scientific discipline or equivalent experience with contract research & product development
At least 6 years of drug development experience
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| Research & Development | |
| Director, Analytical R&D | |
| Reporting to the Vice President of US R&D, this position will focus on supporting analytical development of assay methods, work closely with Product Development Scientists and other company groups to direct and oversee all activities related to the development, qualification, validation, and transfer of analytical procedures to support North American registration and commercialization of new products. Required are a PhD in Chemistry or other, closely allied science, and at least 10 years of pharmaceutical experience, coupled with significant supervisory experience.
Company is a rapidly growing, multi-national manufacturer of Rx, OTC and nutritional products, located in a highly desirable area of NC. | |
| 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 Contact: Phil Ellis | |
| Director, Technical Service | |
| For this fast growing, multi-national manufacturer of pharmaceuticals, located near RTP, NC. Manage Technical Services and Validation Groups which perform scale-up, technical transfer, process development, process improvement, trending, and valdiation for oral solid dose products. Education: BS/BA in Science or Engineering. Masters a plus. Work Experience: 10 or more years of progressively responsible experience in the pharmaceutical industry; ideally in solid dosage generics technology. Prior experience supervising, leading and directing groups with diverse technology and business backgrounds. Must have a broad based knowledge of manufacturing processes and equipment, technical transfer methodology, a solid understanding of cGMP’s, validation processes, process automation and control. Knowledge of current industry validation strategies and a prior experience working with R&D bringing products to market. Understanding and commitment to Lean/Six sigma strategies.
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| Manager, Product Launch | |
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For assigned projects, manage all stages associated with the manufacture of a new product, from pre-formulation development through the final transfer to commercial production. Coordinate with internal and external contacts as necessary. Assist with development of department timelines, budget, and resource requirements. Comprehensively manage the department’s projects as assigned by either the Director Technical Services of VP Technical Operations Technology relating to the department’s technical services (pre-formulation, formulation development, process optimization, etc.) and the manufacture of clinical trial materials. Coordinate and schedule the department’s and site resources including personnel, equipment, technologies, materials, testing facilities, and related staff functions to accomplish assigned goals and project timelines. Coordinate the department’s activities with other departments or outside contractors. Identify and report any resource deficiencies and assist in the development of timely courses of action to achieve assigned goals and project timelines. Assist with the evaluation of project needs, preparation of quotations and invoicing, development of project timelines and preparation of departmental fiscal budgets. Interact with various departments to ensure customers are informed of the progress of their project and assist in meeting any needs that may arise. Minimum requirements Education/Experience: MS in a technical discipline Minimum of 7 years of pharmaceutical solid-dosage product / process development and/or manufacturing or Bachelor’s degree in a technical discipline Minimum of 10 years extensive experience in pharmaceutical product/process development and/or manufacturing 3 years of direct project leadership experience, including experience effectively communicating information and responding to questions from cross-functional departments Additional Competencies: Strong interpersonal, team management, communication and presentation skills Ability to successfully manage multiple projects to achieve company objectives Competency in the use of common computer software packages Project planning skills including the ability to write reports and project timelines Knowledge of the design, application and trouble-shooting of pharmaceutical equipment, systems and facilities Familiar with common compounds used in the manufacture of pharmaceutical solid-dosage products and their proper application Thorough understanding of FDA regulations with emphasis on cGMP and their application Ability to develop training programs and provide hands-on training to personnel at various levels with the organization Required years of experience - Above Ten Years
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| 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 Contact: Lee Douglas | |