Director, Biologics Process Development (BPD)

Role Summary

Director, Biologics Process Development (BPD) leading a team of scientists in Rahway, New Jersey to support drug substance process development for early and late-stage programs using fed-batch and continuous manufacturing. Designs and implements bioprocess technology platforms for upstream and downstream processes to achieve high yields and superior product quality, enabling clinical studies and commercial launch. Manages a team of 10–15 scientists and a portfolio of 3–6 programs, collaborates with cross-functional teams, and oversees external partnerships for timely execution.

Responsibilities

• Lead and develop a team of scientists in biologics process development, including mammalian cell culture or purification process development, tech transfer, and regulatory filings.
• Design and implement novel bioprocess platforms and processes for upstream and downstream operations to deliver high yield and quality for clinical and commercial programs.
• Manage cross-functional CMC teams and coordinate with Process Cell Science, US Operations, Clinical Manufacturing, and Commercial Manufacturing groups.
• Recruit, appraise, and develop personnel; maintain internal networks and promote scientific excellence and compliance with company procedures for timekeeping, data entry, and trainings.
• Communicate program progress, risks, and mitigation plans to senior management; serve as a decision-making facilitator and talent developer for the direct team.
• Collaborate in a fast-paced, matrixed environment and manage external partners to ensure timely execution of work.

Qualifications

• Minimum Education: Ph.D. in Biochemistry, Biologics Sciences, Chemical Engineering, or related field with 10+ years of pharmaceutical industry experience; or MS with 13+ years; or BS with 15+ years.
• Experience and skills in biotherapeutic process development (cell line, upstream, or downstream) or manufacturing; ability to develop realistic project plans for timely execution.
• Proven ability to lead and develop staff; extensive experience as a drug substance lead for biologics programs; strong program risk management and timeline management.
• Deep knowledge in upstream cell culture or downstream purification to support pipeline projects, platforms, and technologies.
• Proven track record of regulatory submissions input (INDs, IMPDs, Clinical Trial Applications).
• Ability to work with cross-functional stakeholders to align with functional objectives; strong communication of progress and mitigation plans to senior management.
• Innovative mindset evidenced by technical accomplishments, external presentations, and publications.

Skills

• Bioprocess Development, Mammalian Cell Culture, Cell Culture Process Development
• Process Scale Up, Downstream Purification, Upstream/Downstream Integration
• Regulatory Submissions (INDs, IMPDs, CTAs)
• Project Planning, Program Risk Management, Cross-Functional Teamwork
• Mentoring, People Leadership, Negotiation

Education

• Ph.D. in Biochemistry, Biologics Sciences, Chemical Engineering, or related field (required).
• Alternative: MS or BS with substantial industry experience as listed in qualifications.