SUMMARY:
The Principal Scientist (Vector) - Manufacturing Sciences and Technology will be responsible for designing, leading, executing and overseeing internal and external studies and teams to support product and process optimization and automation, aseptic process validation and requalification campaigns, technology transfer activities, BLA supporting process and product characterization studies, BLA authoring, investigation into deviations and root cause analysis, change management and any activities required by the MS&T organization. This position bridges deep viral-vector knowledge with external manufacturing management and internal DS/DP manufacturing ensuring outsourced vector production (LVV) meets yield, quality, and regulatory requirements.
DUTIES AND RESPONSIBILITIES:
The following reflects management's definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign
duties and responsibilities to this job at any time due to reasonable accommodation or other reasons.
• Provide technical leadership and support for technology transfer, process optimization, and technology evaluation to support development and commercialization of new and existing products.
• Develop, qualify, and execute phase-appropriate studies for the characterization and development of multiple pipeline products
• Leads process lifecycle management for both commercial and approaching BLA CGT programs.
• Collaborate with Quality Assurance, Regulatory Affairs, Analytical Sciences, Supply Chain, and Facilities to align strategic priorities and project timelines.
• Utilize statistical process control tools to monitor manufacturing metrics, prepare continued process verification reports, and ensure inspection readiness.
• Mentor junior scientist and foster a culture of collaboration and technical excellence. May manage a small to mid-sized team
• Represent Manufacturing Sciences and Technology team in cross-functional technical meetings.
• Aseptic process lead and oversight: coordinate across multi disciplines, including QA, QC Micro, Manufacturing, MS&T, Regulatory, Engineering, for aseptic process validation activities, ensuring timely execution and audit readiness.
• Provide aseptic process technical expertise and guidance for risk assessments, validation documentation.
• Act as SME for sterility assurance topics, supporting investigation and leading continuous improvement to improve the aseptic simulation program.
• Facilitate product transfers by aligning aseptic validation approaches.
• Review and approve change controls, ensuring validation impact assessments, and appropriate testing to maintain validated states.
• Support the execution of improvement projects, liaising with all the relevant parties to ensure accurate execution.
• Support with any internal or external audit.
Lifecycle management:
• Lentiviral process subject matter expert (SME) for deviations, root cause investigations, root-cause analyses, and CAPAs related to LVV vector production.
• Manage lentiviral vector manufacturing process lifecycle governance.
• Evaluate lentiviral manufacturing process changes, shipping validation parameters, deviations, and out-of-trend events.
• Interface with contract development and manufacturing organizations for external lentivirus production.
• Author, review, and defend lentiviral vector process
QUALIFICATIONS:
Required:
• B.S., M.S. or Ph.D. in cell and/or molecular biology, engineering, or relevant discipline with a minimum of 4 years (PhD), 8 years (M.S.) or 10 years (B.S.) of industry experience.
• Proven understanding of aseptic techniques, FDA/EU regulatory requirements and guidelines for validation.
• Knowledge and experience in developing manufacturing processes with understanding of regulatory constraints relating to cGMP, Annex 1, and ATMP guidance.
• Experience in working in cross-functional environments, and with internal/external partners to perform process transfer for cGMP production.
• Proficiency in project management and resource planning • Strong understanding of adeno-associated virus (AAV), or lentivirus vector (LVV) production is required
Desirable:
• Experience managing or providing oversight of CROs/CMOs
• Experience with regulatory submissions (IND, BLA, MAA) for advanced therapies.
• Proficiency in Quality by Design (QbD) principles and statistical data analysis.
The physical demands and work environment 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.
PHYSICAL DEMANDS:
• Frequently required to stand
• Frequently required to walk.
• Frequently required to sit.
• Frequently required to talk or hear.
• Occasionally required to lift light weights (less than 25 pounds)
• Specific vision abilities required for this job include: close vision, color vision and ability to adjust or focus
