Director, Downstream Process Development - Biologics

Role Summary

Director, Downstream Process Development - Biologics

Responsibilities

• Lead phase-appropriate strategies for downstream process development, process transfer, scale-up and process characterization to support commercial readiness.
• Set-up and oversee external capabilities for downstream process development of monoclonal antibodies, ADCs and other biologics modalities. This includes directing activities such as capture chromatography, polishing steps, and viral clearance.
• Develop and manage project timelines, resource allocation, and budget for downstream programs.
• Oversee drug substance technology transfer, process development and GMP manufacturing operations at CDMOs, in close partnership with upstream 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.
• Develop and implement strategies for improved purification efficiency, robustness, and cost-effectiveness, including evaluation of new technologies and materials.
• Potential in the future to build and manage a team of scientists and engineers to deliver high-quality, scalable, and compliant downstream drug substance processes from early development through commercialization.
• Expected travel: 10-20% (domestic and international)

Qualifications

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

Experience & Skills

• Demonstrated leadership in downstream process development for recombinant proteins including antibodies, ADCs, and fusion proteins.
• Hands-on experience with chromatography systems (AKTA, Unicorn), UF/DF systems, and viral clearance strategies. Familiarity with continuous purification technologies and single-use systems is strongly preferred.
• Experience successfully delivering development programs with CDMOs.
• Strong track record of scaling processes from lab to pilot and GMP/commercial production.
• Proven track record of advancing drug substance from INDs into late phase development and commercialization.
• Experience with process characterization, process control strategy establishment and process performance qualification for commercialization using Quality by Design (QbD) principles.
• Extensive knowledge of cGMPs and regulatory guidelines for biologics and can serve as an internal thought-leader to drive decision making.
• Strong data analysis and scientific communication skills, including experience with regulatory documentation, with the ability to influence and drive decision making at multiple levels within a CMC organization.
• Demonstrated leadership with experience managing technical staff (internal or external) and cross-functional collaborations.