Associate Director, Process Development

Job overview

The Associate Director, Process Development role is onsite in Princeton, NJ. Compensation is not specified. MADE Scientific operates in a contract development and manufacturing organization environment supporting cell therapy programs. The role provides scientific and technical leadership for cell therapy process development from preclinical through commercial manufacturing. It supports scalable, compliant processes, technology transfer, manufacturing operations, regulatory activities, and development of the process development team.

What you'll do

• Lead process development for upstream cell expansion, gene modification, harvest, formulation, and cryopreservation
• serve as technical subject matter expert for client programs
• support troubleshooting, root cause analysis, deviations, investigations, and CAPAs
• develop and review experimental plans, process descriptions, SOPs, risk assessments, and gap analyses
• support scale-up, process characterization, comparability, validation, and GMP manufacturing
• contribute to proposals, client meetings, regulatory filings, inspections, and audits
• build and lead a process development team
• mentor scientists and engineers.

What we're looking for

Skills & competencies

associate director

process development

cell therapy

manufacturing processes

gmp

technology transfer

process scale-up

regulatory support

client programs

made scientific inc

princeton nj

full-time

scientific leadership

team development

Work arrangement

• Weekend coverage required

Why this role

Cell therapy process development leadership spanning preclinical through commercial manufacturing in a CDMO environment.

About the employer

MADE Scientific Inc is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.