Principal Scientist (Vector) - MSAT

USWM, LLC•Philadelphia, PA

2d•$104,000 - $148,000

About The Position

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.

Requirements

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

Nice To Haves

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.

Responsibilities

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.
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