Requiring Office: JPM MCS Team: JVAP Support
Location: Ft. Detrick, MD – On-site
Position Sub-Title: Biologics Manufacturing
Responsibilities and Duties
- Provide onsite presence at the manufacturing office/facility, which may involve extended travel, and shall monitor and report the contractor’s progress, as well as any risks, issues, or problems identified.
- Perform day-to-day oversight of activities at the manufacturing site.
- Ensure best practices and execution of current Good Manufacturing Practices (GMP) for development, manufacture, and release.
- Identify upstream and downstream process changes to enhance compliance and improve the manufacturing process. In addition, the contractor shall develop process flow diagrams depicting the manufacturing process.
- Work to maintain an IMS and ensure all tasks are completed within schedule expectations.
- Assist the risk manager in risk identification, analysis, and mitigation.
- Communicate regarding technical and compliance risks and data.
- Collaborate to develop resolutions to risks or issues.
- Assist with technology transfer efforts, to include working with the PM(s) and Manufacturing Lead(s) to develop a process for transfer of data, information, materials, and knowledge.
- Review and provide comments to product transition plans, bridging studies, Technology Transition Agreements (TTAs) and Technical Data Packages (TDPs).
- Assist with multiple complex technology transfer sub-projects related to manufacturing and testing to ensure that each sub-project meets cost and schedule expectations.
- Verify that process parameters are still within the determined design space after technology transfer is complete.
- Review and critique documentation and verification associated with the technology transfer processes.
- Participate in routine and ad-hoc meetings and teleconferences to review and timely completion of action items and execution of technology transfers.
- Collaborate on and review technical documents to advance development/acquisition.
- Assist in writing and reviewing US CMC regulatory documents.
- Review documentation and support resolution of deviations through corrective and preventive actions.
- Review development and manufacturing data to ensure that processes are operating in a state of control.
- Identify process changes to enhance compliance and improve manufacturing process, as needed.
- Ensure appropriate subject matter experts are involved in the day-to-day management of manufacturing efforts.
- Participate in various Government and non-Government IPTs.
- Maintain communication with supervisors, peers, or subordinates via telephone, e-mail, or in person.
- Work independently and as part of a team.
- Ensure that the CMO(s) meets best practices and execution of non-GMP manufacture of analytical reagents (e.g., recombinant Glycoproteins, monoclonal/polyclonal antibodies, etc.) used in testing of vaccines during manufacture (i.e., in-process testing) and subsequent release. (i.e., recombinant protein and viral vaccines).
- Oversee process performance qualifications to ensure execution of current GMP during manufacturing, engineering, and production runs for both the drug substance and drug product.
- Oversee the process to validate and complete all documentation required for introduction of new equipment. (i.e., SOPs, manufacturing sections of SOWs, White Papers, RFIs, testing protocols, technical reports, batch files, and technical transfer documents)
- Work in conjunction with the manufacturing team to review and identify errors in analytical assay reports, qualification/validation documents, and batch records.
- Ensure the CMO identifies, in accordance with FDA/ICH guidance, the vendors, suppliers, and raw materials required.
- Review training records of personnel at the CMO to ensure appropriate compliance and competencies.
Qualifications and Skills
- PhD in Engineering, Science, Systems Management, Business Management, or a related discipline
- 8 years of general experience and 5 years of relevant experience.
- Alternate/Tradeoff Requirement: Master’s degree in Engineering, Science, Systems Management, Business Management, or a related discipline, as well as ten (10) years of general experience and seven (7) years of relevant experience.
- Possess technical knowledge of pharmaceutical manufacturing and an understanding of current GMP.
- Possess experience in biologics and the application of ICH Q8, Q9 QRM, and Q10.
- Possess experience with the development, technology transfer, process definition, process qualification, and continued process verification of drug product manufacturing.
- Possess strong analytical and problem solving skills, as well as good organization skills to balance and prioritize work.
- Possess strong interpersonal and communication skills, both oral and written.
- Possess 5 years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval).