The Manager, Manufacturing, Science and Technology (MSAT) will lead the technical transfer and process support activities for sterile biologics. In this role, you will support the insulin program including a dedicated high-speed cartridge filling line, significant utilities upgrade, dedicated formulation and processing suites, with Clean In Place (CIP) and Sanitize In Place (SIP) capabilities. Reporting to the Director, MSAT, you will work with the company’s manufacturing and engineering teams and lead technology transfer for sterile biologics. You will collaborate closely with R&D and develop, transfer, execute, and improve technical transfer processes to meet project and business objectives.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Lead the transfer of sterile biologics production processes and technologies from R&D into site operations.
- Responsible for developing biologics process control strategy document, technology transfer change controls, engineering, clinical, and PPQ batch protocols in coordination with R&D and ensuring that the manufacturing batch record meets established conditions as defined in the CMC documentation.
- Responsible for process stewardship throughout lifecycle management of commercial biologics manufacturing processes. This includes initial manufacturing batch record (MBR) creation, protocol development, authoring, training, and execution support, process troubleshooting, and on-the-floor hyper care as needed.
- Design Process Performance Qualification (PPQ) plan to demonstrate manufacturing process is performing as expected to initiate commercial manufacturing.
- Oversee product technical lifecycle management with regards to process control strategy (post-approval) process/yield improvement, process knowledge management, batch deviations, and ensuring accuracy of regulatory CMC registration detail.
- Support product pre-approval inspection, including direct interaction with regulatory agencies during site inspections.
- Prepare and review, as needed cGMP documents such as batch records, technical protocols, and reports, change controls, deviation reports, validation protocols, and summary reports.
- Work with operations and validation team to prepare aseptic core package for submissions.
- Understand the scientific principles for manufacturing parenteral drug products, device assembly and packaging, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
- Work with site leadership team to build subject matter expertise across functions in the areas of compounding, sterilization, and Single Use assemblies for filtration and filling, device assembly, and visual inspection.
- Work closely with operation and R&D team to perform gap assessment for new product introduction and provide innovative solutions and develop control strategy.
- Charter cross functional tech transfer teams comprising of R&D, QA, QC, Regulatory Affairs, and operations.
- Provide technical leadership for the rapid resolution of technical issues impacting supply through product performance investigations and use of root cause analysis (RCA) tools and appropriate Corrective and Preventative Actions (CAPA) and escalate key site technical issues.
MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)
- Bachelor of Science Engineering or a similar technical degree. A post graduate degree is desired, but not required.
- Minimum of 6 years sterile biologics experience.
- Preferred minimum of 6 years’ experience in biologics technical transfer and process validation.
- Experience working in FDA regulated environment.
- Experience working in parenteral facility operations setting.
- Strong working knowledge of current standards and regulatory expectations for pharmaceutical product development, regulatory filing, and commercialization
- Strong interpersonal, collaboration and leadership skills