Senior Downstream Process Development Manager
Reporting to the Senior Director, Process Development, In Vivo and Gene Editing Components, the Senior Downstream Process Development Manager for the Process and Analytical Development (PAD) team leads downstream process development activities by managing external contract development manufacturing organizations (CDMOs) to support AAV-based in vivo programs in developing safe and effective gene therapies using CRISPR-based gene editing technologies. This role supports formulation, fill, and finish activities, and provides technical expertise and support during engineering runs and Good Manufacturing Practices (GMP) manufacturing to support clinical development. This role also ensures that the downstream manufacturing process is commercial ready and supports process validation efforts for marketing applications. The role contributes to regulatory filings throughout clinical development. Specific duties include: Act as the subject matter expert on AAV downstream process development, and independently manage CDMO downstream process development activities; Design chromatographic, centrifugation, and filtration studies with CDMO for AAV downstream process development, characterization, and performance qualification; and define downstream process control strategies and comparability studies; Lead downstream activity support for technology transfers, scale up and scale down, and manufacturing operations and deviations / investigations by designing and executing appropriate studies at CDMO; Provide technical support for formulation, fill, and finish activities; Independently design and manage the execution of experiments (DOE) at CDMO to generate optimal and robust purification processes; Utilize downstream process derived data (e.g., chromatography, filtration, centrifugation) and literature research to monitor process performance, support deviation reports and technical investigations, and aide in process optimization/development; Assess impact and facilitate closure of deviations, ensure appropriate scoping of change controls and CAPAs, and develop risk assessments related to downstream processes; Author and review technical protocols and reports, CMC regulatory sections, process summaries, study design and protocols, and SOPs; Establish routine downstream process data trending activities; Ensure accurate and complete documentation of any scientific experimental plan, data, or report; Build and maintain good working relationships with internal and external stakeholders, such as Research, Development, Quality, suppliers, and contract manufacturing organizations; Improve the understanding, robustness, and economics of commercial manufacturing processes; Independently analyze data and present results and conclusions to the team; Establish and maintain familiarity with contemporary industrial standards, practices, technologies, literature, and ways of performing lab studies; and Support the preparation of regulatory filings, such as INDs, BLAs, and guidance meeting packages, by providing technical information on manufacturing processes and controls.
Minimum Requirements: Master’s degree or foreign equivalent in Biotechnology or a related field, plus 5 years of relevant industry experience; OR PhD in Biotechnology or a related field, plus 3 years of relevant industry experience.
Must have: Demonstrated understanding of scaling up and scaling down considerations for downstream processes; Demonstrated in-depth understanding and hands-on experience in at least one of: column and membrane chromatography (e.g. affinity, ion exchange), membrane filtration (NFF, TFF, viral filtration), centrifugation, viral clearance study, continuous processing, and process modeling; Demonstrated downstream subject matter expertise and hands-on downstream laboratory experience, including AKTA chromatography and filtration systems operation; Demonstrated understanding of biopharma operations, GxPs, ICH guidelines, process characterization, and technology transfer; Demonstrated ability to lead problem solving for issues related to downstream process development, qualification, and validation; Proven project management skills, including ability to prioritize project work and make effective use of available resource to meet agreed timelines; Demonstrated ability to manage multiple tasks and meet deadlines; Demonstrated ability to manage in a matrix environment; Demonstrated strong technical writing skills; Demonstrated ability to author and approve comprehensive and accurate protocols/reports; Demonstrated ability to function independently and communicate cross functionally across various teams; and Demonstrated ability to manage priorities and engage/communicate in a multidisciplinary environment.(Unless otherwise indicated, the employer is seeking ability in skills listed above with no specific amount of years of experience required. All experience can be gained concurrently).
Up to 10% domestic travel may be required.