Director/Sr. Director, CMC Fill Finish/Drug Product
75 Shoreway Rd, Suite A San Carlos, CA 94070
We’ re seeking an experienced, highly motivated, and adaptable leader in biologic drug product manufacturing to become an integral part of our CMC team. As a member of our CMC team, you’ ll plan, coordinate, and drive drug product CMC activities at a number of contract manufacturers, including scale-up for cGMP manufacturing. In addition to CMO oversight, you’ ll be responsible for conducting troubleshooting and investigations and supporting cGMP manufacture, to achieve timely delivery of cGMP therapeutics to support clinical trials. You’ ll work as a part of a highly collaborative CMC group to support IND filings and serve as a subject matter expert on cross-functional teams. This is an opportunity to learn, to grow and to achieve at the leading edge of science and medicine. This role will report to the Vice President Manufacturing.
? Work with a diverse organization that may include both internal and external resources and be distributed over a wide geographic area. Budgetary responsibility is considerable, and emphasis is placed on achieving specific budget targets. Responsible for operating all activities in a manner that complies with appropriate safety, regulatory and legal requirements
? Manage CMO/CRO relationships, to include planning, coordination and technical oversight of drug product activities. Serve as primary contact to support drug product manufacture.
? Run and document appropriate meetings, manage procurement and payment of invoices, and ensure timely communication between the contract sites and Omniox management.
? Provide technical leadership and direction to CMO/CROs and internal scientists for process optimization, transfer, and troubleshooting
? Support manufacturing campaigns with Person-in-Plant activities, deviation investigation and closure, and technical batch record review for batch release.
? Author and review batch records, development and technical reports, campaign reports, and other drug product documents as required. Participate in preparation of CMC sections of regulatory filings
? Apply QbD concepts to manufacture; identify potential process improvements and apply current technologies to the process; and contribute to CMC drug product strategy and continuous process improvement for next generation process
? Design and plan efforts to improve process efficiency and yields and reduce cost of goods
? Conduct unbiased, timely, and economical comparisons of possible partners during competitive bidding processes and requests for proposals.
? Act as subject-matter expert on cross-functional teams; collaborate closely with drug substance, process engineering, analytical, QA, regulatory affairs, and other CMC team members.
? Present technical, quality and commercially focused information to diverse audiences in a clear and consistent manner
? Provide vision concerning production methods, equipment, process validation requirements (IQ, OQ, PQ), CMC testing and supply chain management tools
- BS/BA degree in Chemistry, Biochemistry, Chemical Engineering or a related discipline and at least twenty years of experience in a biopharmaceutical environment or related experience
- MS/MA degree in Chemistry, Biochemistry, Chemical Engineering or a related discipline and at least fifteen years of experience in a biopharmaceutical environment or related experience
· Extensive experience in clinical and commercial pharmaceutical manufacturing is required, with preference given for recombinant biopharmaceutical parenteral products.
· Demonstrated experience in process scale-up and process transfer, and manufacturing
· Experience supporting cGMP manufacturing through all phases of development (pre-IND to commercial); must have experience with IND filings
· In depth experience with FDA, EMA and industry and international regulatory and safety guidelines (21 CFR part 11, GMP, ISO, etc.).
· Demonstrated ability to multi-task in high pressure, changing conditions in a global development and manufacturing environment. Ability to prioritize competing activities and effectively present prioritized actions for others to execute.
· Demonstrated ability to successfully operate and direct 3rd party vendors supplying products and services. Excellent communication, interpersonal skills, and people management skills through all levels of the organization.
· Frequent domestic and international travel is required to support manufacturing campaigns; must be able to work flexible working hours including weekends and holidays, as occasionally required