Associate Director, Process Development

Made Scientific, Inc.; East Norriton Township (Montgomery County); Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

Made Scientific, Inc. is seeking an Associate Director of Process Development to lead the lifecycle management of autologous and allogeneic cell therapy manufacturing processes in a CDMO setting.

You will drive scalability, compliance, and client interactions from preclinical to commercial stages. The role requires deep expertise in cell therapy, cross-functional leadership, and regulatory readiness across FDA/EMA frameworks, with mentorship and strategic PD planning to support growth and client

Qualifications

• 15+ years of experience in biopharmaceutical manufacturing or process development.
• 5+ years of leadership experience in MSAT, technical operations, or process development.
• Strong experience with cell therapy manufacturing (e.g., CAR-T, TCR-T, NK cells, stem cell therapies).
• Experience in CDMO environments strongly preferred.

Responsabilités

• Provide scientific and technical leadership for cell therapy manufacturing processes including upstream cell expansion, gene modification, harvest, formulation, and cryopreservation.
• Serve as the technical SME for manufacturing processes supporting client programs.
• Assist in troubleshooting and root cause analysis for deviations, investigations, and CAPAs.
• Drive implementation of process development methodologies.
• Develop and review experimental plans, bill of materials, process descriptions, equipment SOPs, risk assessments, and gap analyses.
• Ensure successful scale-up and scale-out across CDMO facilities when applicable.
• Assist in process characterization, comparability studies, and validation support.
• Provide real-time support to GMP manufacturing operations for clinical and commercial batches.
• Drive thought leadership on Cell Therapy Manufacturing.
• Provide expertise into business development processes, including review of proposals, contracts, and marketing material.

Connaissances

Leadership

Project management

Cross-functional collaboration

Communication

GMP knowledge

Cell therapy manufacturing

Regulatory understanding

Formation

PhD or MS in Biochemical Engineering, Cell Biology, Bioengineering, Biotechnology, or related field

Description du poste

Position Summary

The Associate Director of Process Development provides scientific and technical leadership for the development and lifecycle management of autologous and allogeneic cell therapy manufacturing processes. This role leads process development activities from preclinical through commercial manufacturing, supporting scalable, robust, and compliant processes within a CDMO environment. The position partners cross-functionally and with clients to advance programs, technology transfer, and continuous process improvement.

Key Responsibilities

• Provide scientific and technical leadership for cell therapy manufacturing processes including upstream cell expansion, gene modification, harvest, formulation, and cryopreservation.
• Serve as the technical subject matter expert (SME) for manufacturing processes supporting client programs.
• Assist in troubleshooting and root cause analysis for manufacturing deviations, investigations, and CAPAs.
• Drive implementation of process development methodologies
• Develop and review experimental plans, bill of materials, process descriptions, equipment SOPs, risk assessments, and gap analyses.
• Ensure successful scale-up and scale-out of manufacturing processes across CDMO facilities when applicable.
• Assist in process characterization, comparability studies, and validation support.
• Provide real-time support to GMP manufacturing operations for clinical and commercial batches.
• Drive thought Leadership on Cell Therapy Manufacturing
• Provide expertise into business development processes, to include review of proposals, contracts and marketing material.
• Review batch records, deviations, and change controls related to process changes as needed.
• Present technical updates during client meetings and governance reviews.
• Support proposal development, technical due diligence, and new program onboarding.
• Ensure PD activities align with cGMP, FDA, EMA, and ICH regulatory requirements.
• Contribute to regulatory filings including INDs, BLAs, and comparability packages.
• Support regulatory inspections and client audits.
• Build and lead a high-performing PD team, including scientists and engineers.
• Provide mentorship, technical guidance, and performance management.
• Develop PD strategy aligned with organizational growth and client pipeline.
• Performed other duties as assigned by Head of Development.

Required 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 of leadership experience in MSAT, technical operations, or process development.
• Strong experience with cell therapy manufacturing (e.g., CAR-T, TCR-T, NK cells, stem cell therapies).
• Experience in CDMO environments strongly preferred.
• Deep knowledge of:
• Cell culture and cell expansion technologies
• Viral vector transduction or gene editing workflows
• Closed and automated cell therapy manufacturing platforms
• Cryopreservation and fill-finish for cell therapy
• Experience with tech transfer, process validation, and process characterization.
• Familiarity with statistical process monitoring and data analytics tools.
• Strong cross-functional leadership and project management skills.
• Experience working directly with biotech clients.
• Excellent written and verbal communication skills.
• Ability to operate in a fast-paced CDMO environment with multiple client programs.

Preferred Qualifications

• Experience with commercial cell therapy manufacturing.
• Experience with automated manufacturing platforms (e.g., CliniMACS Prodigy, Lonza Cocoon).
• Knowledge of viral vector manufacturing.

Physical Requirements

• Ability to perform the essential job functions consistent safely and successfully with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
• Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state, and local standards.
• Must be willing to be gown qualified and work in BSL-2 lab/CNC/ISO7/ISO8 facility.
• Must be able to lift and carry up to 30 lbs.
• Must be willing to bend, stoop, carry, reach, climb or stand on an elevated bench or step stool.
• Must be willing to sit or stand for extended periods.
• Must be willing to work with cell-based products, chemicals or hazardous materials.

Work Environment

• Work is performed in a combination of manufacturing, laboratory, warehouse, mechanical, and office environments.
• May work around manufacturing equipment, mechanical systems, chemicals, and hazardous materials.
• Required to wear appropriate personal protective equipment (PPE) and follow applicable safety and GMP requirements.
• May require occasional work outside of normal business hours to support maintenance needs or facility emergencies.
• Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of the position.

Equal Employment Opportunity Statement

Made Scientific is proud to be an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace. We make employment decisions based on qualifications, merit, business needs, and job requirements without regard to race, color, religion, creed, sex, pregnancy, childbirth or related medical conditions, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship status, or any other status protected by applicable federal, state, or local law. Made Scientific is committed to providing reasonable accommodations to qualified individuals with disabilities and to applicants and employees with sincerely held religious beliefs, practices, or observances, unless doing so would create an undue hardship.