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.

 

Summary:

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.  

 

Essential Functions:

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.

Other Information

  • Position may require occasional travel (~25%), domestic and international.

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