The Large Molecule Analytical Development group is seeking a Scientific Director who will serve in the Large Molecule Value Stream (LM VS) Scientific Leader role, providing strategic and scientific guidance to teams and individuals responsible for the CMC development of large molecule therapeutics and their post-licensure life cycle management, including support of manufacturing investigations.
Responsibilities include but are not limited to:
- Provide strategic and scientific guidance in all CMC technical areas, in particular, serve as the large molecule analytical development expert on biological assays, structure-function relationships, test method development and validation and establishment of specifications
- Guide teams in the preparation of technical reports and regulatory submissions, participate in their review and approval, and contribute to development of strategies to comply with US and international regulatory standards
- Provide scientific guidance on complex manufacturing investigations
- Lead discussions to identify new scientific/technical opportunities for the large molecule product platform, and negotiates/influences acceptance of new opportunities and concepts through scientific leadership
- Support a learning environment and foster a culture of scientific excellence through training, influence and leading by example
- Act as a senior internal expert with a direct impact on PDMS Large Molecule Value Stream business objectives. Key partners include API and DPD functional leaders, CMC-Leaders, Janssen supply chain platform leaders, Quality Assurance, Global Regulatory Affairs and Discovery.
- Ph.D. in Biochemistry, Analytical Chemistry, Chemical Engineering or related discipline is required
- At least 12 years relevant experience in biopharmaceutical development, licensure and post-marketing support is required
- Primary in-depth experience and knowledge in large molecule analytics, as well substantial experience in other CMC functional areas (ie: Cell Culture, API Purification, Drug Product) is required
- Vaccine and protein conjugation experience is preferred
- Demonstrated ability to develop and transfer biologics manufacturing processes and product testing that meet customer needs is required
- Broad knowledge of the biopharmaceutical industry, including in-depth operating knowledge of the processes and functions involved in biologics drug development and life cycle management is required
- Experience with regulatory submission writing and review (ie: INDs, BLAs, etc) is required
- A proven track record in leading scientific teams, including direct and/or indirect people management experience is requiredRequisition ID: 7662170411