Process Development, Director - Upstream (Biologics)

Role Summary

Lead the design, development, optimization, and scale-up of upstream processes to produce therapeutic biologics, guiding the transition from early development to commercial readiness. Provide technical leadership within the Process Development / Engineering team to advance biologics, cell and genetic therapeutics, with cross-functional collaboration across CMC functions.

Responsibilities

• Lead phase-appropriate strategies for upstream process development, process transfer, scale-up and process characterization to support commercial readiness, including 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 collaboration 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 teams.
• 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) and serve as a subject matter expert in regulatory interactions, audits, and inspections.
• Identify and implement innovative technologies to improve process yields, robustness, and efficiency.
• Potential to build and manage a team of scientists and engineers to deliver scalable upstream drug substance processes from early development through commercialization.
• Expected travel: 10-20% (domestic and international).

Qualifications

• Required Education: PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences or related discipline.
• Required Experience: Minimum of 11 years of experience in drug substance development and manufacturing. MS with 14+ years of relevant experience may be considered.
• Required Experience And Skills: Demonstrated leadership in upstream process development for recombinant proteins including antibodies, ADCs, and fusion proteins; expertise in mammalian cell culture technologies (CHO systems preferred); experience with process scale-up to pilot/commercial scale and tech transfer to GMP facilities; hands-on experience with bioreactor systems; experience delivering development programs with CDMOs; proven track record of advancing drug substance from INDs into late phase development and commercialization; experience with process characterization, control strategy establishment, and process performance qualification using QbD; extensive knowledge of cGMPs and regulatory guidelines for biologics; strong data analysis and scientific communication skills; demonstrated leadership with experience managing technical staff and cross-functional collaboration.

Skills

• Leadership of cross-functional teams and external partnerships (CDMOs).
• Advanced data analysis and regulatory documentation capabilities.
• Strategic thinking and decision-making within a CMC organization.
• Strong communication and collaboration across drug substance, analytical development, formulation, and quality assurance.

Education

• PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences or related discipline (or equivalent).

Additional Requirements

• Travel: 10-20% (domestic and international).