Medix™
Process Development & MSAT Sr Scientist / Manager, Cell Therapy - 257116
Gaithersburg, District of Columbia, US
Role snapshot
Medix™ is hiring a Process Development & MSAT Sr Scientist / Manager, Cell Therapy - 257116 on a full-time basis. This is a role based in Gaithersburg, District of Columbia, US.
- Company
- Medix™
- Location
- Gaithersburg, District of Columbia, US
- Job type
- Full-time
- Experience
- 3–10 years
- Posted
- Nov 2, 2026
Who this role suits
Practitioners with a few years behind them who can work independently, make trade-offs and help newer teammates.
How to prepare your application
- Prepare examples of decisions you drove, how you measured the result, and how you worked with other teams.
- Be ready to discuss trade-offs and scope, not only the tools you have used.
- Read what Medix™ publishes about its product or team, so you can say clearly why this role and this company.
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About the role
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.