Process Development & MSAT Sr Scientist / Manager, Cell Therapy - 257116

Process Development & MSAT Sr Scientist / Manager - Cell Therapy

Location: Gaithersburg, MD

Direct Hire: Permanent, salaried role with excellent benefits package and PTO

We are seeking a hands-on, experienced Senior Scientist or Manager to drive Process Development (PD) and Manufacturing Science & Technology (MSAT) activities for the cell therapy pipeline. In this role, you will lead the design, optimization, scale-up/out, and tech transfer of cell therapy manufacturing processes—specifically focused on cellular products (e.g., T-cells, NK cells, or related immune cell platforms; not viral vectors).

There are no direct reports initially, offering immediate technical leadership and hands-on execution, with a clear runway to build and lead a dedicated PD/MSAT team as pipeline programs advance.

Responsibilities

• Process Development & Optimization: Design, optimize, and scale robust, closed-system, and GMP-compliant cell manufacturing processes, emphasizing product viability, phenotype, yield, and operational efficiency.
• Tech Transfer & MSAT Execution: Lead hands-on technology transfer from development into internal clinical manufacturing or external CDMO partners. Serve as the primary MSAT technical lead for person-in-plant runs, campaign support, deviation triage, and root-cause investigations.
• Process Characterization & Controls: Partner with Analytical Development and Quality to define Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs), and in-process controls for cell drug products.
• Documentation & Regulatory Enablement: Author and review tech transfer protocols, batch production records (BPRs), standard operating procedures (SOPs), process descriptions, and campaign summary reports to support IND and clinical-stage regulatory filings.
• Vendor & CDMO Technical Oversight: Serve as technical owner for CDMO collaborations, raw material qualification, and vendor management, ensuring tight alignment on deliverables and timelines.
• Team Growth: Provide informal technical mentorship immediately; establish standard operational workflows in preparation to hire, supervise, and lead an expanded team over time.

Qualifications

• M.S. or Ph.D. in Bioengineering or a related discipline, with 3-10 years of relevant industry experience.
• Cell Product Expertise: Direct, hands-on experience in cellular process development and cell manufacturing (e.g., autologous or allogeneic T-cells, CAR-T, TCR, NK cells, or related cell therapeutics). Note: Role focuses on the cellular product itself, not viral vector production.
• Tech Transfer & MSAT Track Record: Demonstrated experience executing technology transfers, drafting batch records, and troubleshooting process issues within a cGMP or CDMO setting.
• Start-Up Agility & Resourcefulness: Prior experience in an early-stage biotechnology or start-up environment; demonstrated ability to thrive in a fast-paced, fluid setting, wear multiple hats, and solve technical challenges effectively with lean resources.
• Communication & Growth Mindset: Excellent cross-functional collaboration skills with the drive to balance hands-on technical execution today with future team leadership.