Title: Sr. Manager/ Associate Director, Analytical Development
Location: Menlo Park, CA
Forty Seven Inc. is committed to helping patients defeat their cancer. We are advancing immuno-oncology through the engagement of new and complementary phagocytic pathways that enhance anti-tumor efficacy and selectivity.
Forty Seven is seeking a highly motivated individual willing to provide scientific and technical leadership to support Biologics product development from early stage to commercial launch. The position will manage a full scope of analytical activities including method development, method qualification/ validation and transfer, RS management, product characterization and comparability. In addition, the position will oversee and manage external QC testing sites including data review and deviations/ investigations. Other responsibilities will include cross-functional support and authoring and /or reviewing regulatory dossiers.
The position directly reports to Director of Analytical Development.
These may include, but are not limited to, the following; other duties may be assigned
- Manage analytical method development, qualification/validation and transfer at external testing sites including protocol/ report review and approval
- Oversee the external testing site activities and manage the timelines and deliverables
- Review analytical data and provide technical assessment to support deviations/ investigations
- Generate internal GMP documents to support batch disposition, product quality assessment and change management
- Manage Reference standard and critical reagents
- Write/review analytical related regulatory dossiers and participate regulatory meetings if needed
- Support comparability, product characterization and CQA assessment
- Work closely with cross functional groups to ensure timely analytical support for cell line, process and formulation development.
Education & Experience:
- PhD in Analytical Chemistry or related disciplines or MS with equivalent experience
- 7-10 years of in-depth analytical development experience for biologics from lead selection to clinical development and commercial launch
- Good understanding of methodologies of analytical methods used for release and characterization
- Extensive experience on analytical method development, transfer, validation and product quality assessment
- Hands on experience on analytical technologies such as HPLC, CE, peptide map, mass spectrometry, ELISA, and cell-based bioassay is required
- Experience with product characterization, comparability, CQA assessment and justification of specification
- Experiences with vendor management and QC operation are highly desired
- Knowledge of cGMP’s, regulatory guidelines, validation practices, and other relevant regulatory requirements.
- Excellent interpersonal communication and presentation skills with ability to multi-task.
- Position may require occasional travel (~25%), domestic and international.