Lead, Cell Therapy Process Development & Tech Transfer

MADE Scientific Inc

Eagleville (PA)

On-site

USD 180,000 - 240,000

Full time

8 days ago

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Job summary

MADE Scientific Inc. is seeking an Associate Director of Process Development in Eagleville, PA.

This exempt, full-time role leads development of autologous and allogeneic cell therapy manufacturing processes from preclinical to commercial stages, partnering with clients to advance programs, tech transfer, and continuous improvement. You will oversee technical leadership across manufacturing steps, contribute to regulatory filings, and build a high-performing PD team within a fast-paced CDMO

Qualifications

PhD or MS in Biochemical Engineering, Cell Biology, Bioengineering, Biotechnology, or related field.
15+ years of experience in biopharmaceutical manufacturing or process development.
5+ years in MSAT, technical operations, or process development leadership.
Strong experience with cell therapy manufacturing (CAR-T, TCR-T, NK, etc).
CDMO experience preferred; regulatory and GMP familiarity essential.

Responsibilities

Provide scientific and technical leadership for autologous and allogeneic cell therapy processes from preclinical to commercial scales.
Serve as SME for manufacturing processes supporting client programs.
Lead investigations, CAPAs, and root cause analyses.
Drive implementation of process development methodologies and tech transfer.
Develop and review process descriptions, BOMs, SOPs, risk assessments, and gap analyses.
Ensure scale-up/scale-out across CDMO facilities and regulatory alignment (cGMP, FDA/EMA/ICH).
Support regulatory filings (INDs, BLAs) and client audits.