Director, Drug Product Process Development – Biologics

Role Summary

Director, Drug Product Process Development – Biologics. Lead the development and manufacturing of biologics drug products, overseeing formulation development, primary container development, fill-finish process development, technology transfer to CDMOs, and process validation to support clinical pipeline toward commercialization. Work cross-functionally with drug substance development, analytical development, device development and supply chain management in CMC teams to drive technical and strategic decision-making.

Responsibilities

• Lead phase-appropriate strategies for drug product development, process transfer, scale-up and process characterization to support commercial readiness.
• Set-up and oversee external capabilities for developability assessment and formulation screening for high concentration biologics, ADCs and other biologics modalities.
• Define and develop robust fill-finish manufacturing processes for liquid and lyophilized drug products in vials, pre-filled syringes and other novel primary packaging.
• Oversee drug product technology transfer, process development and GMP manufacturing operations at CDMOs.
• Define and develop clinical dose preparation and administration strategies for drug products for multiple indications. Collaborate with clinical and supply chain teams to prepare clinical study documentation.
• Collaborate with the device development team to develop combination product presentations such as pre-filled syringes, autoinjectors and advance delivery technologies.
• Define and implement drug substance and drug product stability and shelf-life assessment approaches.
• Develop and manage project timelines, resource allocation, and budget for drug product programs.
• 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 and best practices to improve process robustness, efficiency, and compliance.
• Potential in the future to build and manage a team of scientists and engineers to deliver high-quality, scalable, and compliant drug product processes from early development through commercialization.
• Travel: 10-20% (domestic and international).

Qualifications

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

Experience & Skills

• Expertise in formulation development of recombinant proteins including antibodies, ADCs, and fusion proteins.
• Expertise in developing stable, high concentration liquid formulation and dosage forms for biologics and applying cutting-edge technologies to develop stable drug products.
• Deep knowledge in developing aseptic fill-finish manufacturing process for biologics drug products in vials, pre-filled syringe and cartridge presentation.
• Experience delivering development programs with CDMOs.
• Proven track record of advancing drug products from INDs into late phase development and commercialization.
• Experience with process characterization, process control strategy establishment and process performance qualification for commercialization using QbD principles.
• Extensive knowledge of cGMPs and regulatory guidelines for biologics; internal thought-leader to drive decision making.
• Strong data analysis and scientific communication skills, including regulatory documentation, with ability to influence decision making at multiple levels within a CMC organization.
• Demonstrated leadership with experience managing technical staff and cross-functional collaborations.