Director of Process Development/Technical Operations

Director, Process Development

The Director, Process Development/ Technical Operations is responsible for managing the drug substance and drug product development, manufacturing, scale-up, and validation activities of a biologics product at the CDMOs, serving as a technical subject matter expert. This position collaborates closely with colleagues in Technical Operations, Quality, and Regulatory, supporting the corporate goals for clinical development to commercialization of a biologics drug product for a rare disease indication.

Responsibilities:

• Provide technical oversight of the manufacturing and scale-up of a biological product at the CDMOs.
• Review and approve pre-BLA studies, such as process characterization protocols and reports, in collaboration with the CDMOs.
• Provide technical review and approval for manufacturing-related documents including change notifications, batch records, process development, tech transfer, and validation protocols/reports.
• Verify suitability, qualification, and validation of processes at CDMOs and other external laboratories.
• Provide technical support for quality systems governing GMP manufacturing including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections.
• Provide CMC development and manufacturing support on internal and external project teams.
• Maintain up-to-date knowledge of US and EU GMPs and other regulatory guidance applicable to pharmaceutical production.
• Author and review CMC sections of regulatory submissions.
• Write technical reports on a variety of process development-related subjects.

Education/Experience Requirements:

• M.S. in Biochemistry, Chemistry, Chemical Engineering, or other related discipline. Ph.D. degree highly preferred. Equivalent combination of education and applicable job experience may be considered.
• Minimum 8+ years of relevant experience including biologics manufacturing, scale-up, and late-stage drug development and commercialization.

Additional Skills/Experience:

• Expertise in biologics production and aseptic fill/finish, including lyophilization, is necessary.
• Manufacturing experience with microbial production and PEGylation is a plus.
• Experience in managing late phase/commercial programs.
• Expert knowledge in process development, QbD, validation, and technology transfer procedures.
• Strong professional experience in a similar role within the pharmaceutical industry, preferably in biologics development.
• Broad knowledge and experience within the GMP environment and regulatory affairs.
• Successful record of creating and managing complex project plans, timelines, and budgets, and development of risk mitigation strategies.
• Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
• Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
• Excellent decision-making and collaboration skills with strong attention to detail.
• Six Sigma and statistical knowledge is a plus.
• Ability to travel 20%-25% domestically and internationally.