Process Development, Director - Upstream (Biologics)

Role Summary

Process Development, Director - Upstream (Biologics) lead the design, development, optimization, and scale-up of upstream processes to produce therapeutic biologics. Drive the development of upstream process development for biologics such as mAbs, ADCs and fusion proteins, and collaborate across CMC teams to support clinical pipeline toward commercialization.

Responsibilities

• Lead phase-appropriate strategies for upstream process development, process transfer, scale-up and process characterization to support commercial readiness. This includes cell line evaluation, media/feed strategy optimization, bioreactor operations, and scale-up.
• Set-up and oversee external capabilities for upstream process development of monoclonal antibodies, ADCs and other biologics modalities.
• Develop and manage project timelines, resource allocation, and budget for upstream programs.
• Oversee drug substance technology transfer, process development and GMP manufacturing operations at CDMOs, in close partnership with downstream development, analytical development, formulation, external manufacturing and quality assurance.
• Manage deviations and OOT/OOS investigations at the CDMOs in collaboration with Quality, External Manufacturing and Regulatory team.
• Define and implement control strategies, validation protocols, and process characterization studies in accordance with Quality by Design (QbD) principles.
• Author and review regulatory submissions: IND/IMPD, briefing books and BLA.
• Serve as a subject matter expert in regulatory agency interactions, audits, and inspections.
• Identify and implement innovative technologies (e.g., perfusion systems, single-use bioreactors, process intensification) to improve process yields, robustness, and efficiency.
• Potential in the future to build and manage a team of scientists and engineers to deliver high-quality, scalable, and compliant upstream drug substance processes from early development through commercialization.
• Travel: 10-20% (domestic and international).

Qualifications

• Required Education: PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences or related discipline; commensurate years of education and experience.
• Required Experience: Minimum of 11 years in drug substance development and manufacturing (MS with 14+ years may be considered).

Skills

• Demonstrated leadership in upstream process development for recombinant proteins including antibodies, ADCs, and fusion proteins.
• Expertise in mammalian cell culture technologies (CHO preferred); experience with continuous bioprocessing or perfusion-based manufacturing.
• Experience with process scale-up to pilot/commercial scale and tech transfer to GMP facilities.
• Hands-on experience with bioreactor systems (Ambr, benchtop, pilot, commercial).
• Experience delivering development programs with CDMOs; track record advancing drug substance from INDs to late phase.
• Process characterization, control strategy establishment, and PQ for commercialization using QbD principles.
• Extensive knowledge of cGMPs and regulatory guidelines for biologics; ability to drive decision making.
• Strong data analysis and scientific communication skills; experience with regulatory documentation and influencing decisions at multiple levels in CMC.
• Experience managing technical staff and cross-functional collaborations.