BioPharm Development Administration
Responsible for the departments of Cell Culture Development in Cambridge as well as in San Diego and RTP, structuring and directing process development of cell-culture based manufacturing processes for biologics.
Thorough understanding of cell culture metabolism and nutritional needs of cells in culture.
Very experienced in industrial large-scale requirements for robust & reliable manufacturing processes for biologics.
Very knowledgeable of regulatory aspects for making biologics in the US and Europe.
Very knowledgeable of the complexity of requirements of GMP compliance of different agencies.
Very familiar with the operational complexity of scale up of manufacturing processes for biological drugs in general.
Solid background in leadership and excellent managerial skill track record.
Provide direction for the Global development of cell culture processes.
Develop short-term and long-term plans and objectives for the Bioprocess development organization within Technical Development.
Provide expert scientific and strategic opinion to staff, and executive management.
Establish structure and staffing plans of the BioProcess Development Department to support the corporate long-term strategic plans.
Propose ideas for new development programs and provide critique of competing technologies.
Contribute to the Technical Development strategies through effective participation in senior staff meetings.
Interact with Clinical, Legal, Manufacturing, Finance and Business Development in evaluating in-house products and potential in-licensing opportunities.
Assist with the conceptualizing and structuring an efficient infrastructure for the process flow of biological drug candidates.
Develop, implement, and oversee department budget including development and implementation of transparent models, in conjunction with Finance and Production Logistics for cost of goods estimates and global tracking.
Oversee and ensure that the three sites of biologic process development [Cam/SD/RTP] are well coordinated in close cooperation with the 2 other “bicoastal” groups of PBC [Protein Biochemistry] and AD [analytical development].
Ensure that all levels of the Cell Culture Department maintain a smooth partnership with external customers and colleagues in Biologics Manufacturing and Quality.
Chair strategic and team meetings, and collaborate other departments.
Participate and actively contribute in CMC activities related to US and international submissions for INDs, BLAs, clinical studies, and commercial needs.
Attend, participate in and contribute with product/process development and scientific meetings to maintain and improve process development capabilities.
Minimum 10 years experience in a Biotechnology Manufacturing and Life Science environment
Minimum 6-10 years Bioprocess development management experience
Current knowledge of FDA and EMEA regulations and GMP production guidelines
Experience with inspection activities and interacting with investigators
Experience with successful management in internal and external cooperation
PhD with 10-15 years in Biopharmaceutical Sciences environment