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

Medix™; Gaithersburg (MD); On-site; USD 130,000 - 180,000; Full time

Job summary

Medix seeks a hands-on Senior Scientist/Manager to drive Process Development and MSAT for the cell therapy pipeline in Gaithersburg, MD. You will lead design, optimization, scale-up/out, and tech transfer of cellular manufacturing processes, focusing on T-cells, NK cells, or related immune cell platforms.

There are no initial direct reports, but you will provide mentorship and lay the groundwork to build and lead a dedicated PD/MSAT team as programs advance.

Qualifications

• M.S. or Ph.D. in Bioengineering or related field; 3–10 years of industry experience.
• Direct hands-on experience in cellular process development and cell manufacturing (e.g., autologous or allogeneic T-cells, CAR-T, NK cells).
• Proven track record in technology transfers, drafting batch records, troubleshooting in cGMP/CDMO settings.
• Experience in a fast-paced start-up or early-stage biotech environment; multi-tasking ability.
• Excellent collaboration skills with a growth mindset and leadership potential.

Responsibilities

• Design, optimize, and scale closed-system GMP cell manufacturing processes.
• Lead tech transfer from development to internal clinical manufacturing or external CDMOs.
• Define CPPs, CQAs, and in-process controls for cell products.
• Author and review tech transfer protocols, BPRs, SOPs, and campaign reports for regulatory filings.
• Oversee CDMO collaborations, raw material qualification, and vendor management.
• Mentor staff and establish workflows in preparation to grow the team.

Skills

Cell process development

MSAT / Tech transfer

Cross-functional collaboration

Regulatory documentation

Startup agility

Education

M.S./Ph.D. in Bioengineering

Job description

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.