Director/Senior Director Antibody Analytical Sciences and Product Quality

Location
Hayward, CA, United States
Posted
Mar 03, 2021
Ref
194
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
About us:

Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs.

We are located in the San Francisco bay area, in the heart of the world's largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the “rule book” has not yet been written.

Job Responsibilities:

  • Responsible for all analytical and product quality aspects of Arcus' antibody programs
  • Develop and execute an attribute-focused analytical strategy through technical oversight of internal and external activities for drug substance and drug product to enable successful regulatory submissions
  • Ensure robust method development and implementation supporting process and product design including control strategy definition, product characterization, specification setting, and establishing stability and comparability strategies
  • Partner with several other functional areas (e.g., Development, Manufacturing, Clinical, Regulatory, etc.) to ensure that our antibody development and manufacturing activities are always aligned with the highest quality standards (including cGMP compliance) and overall corporate objectives


Qualifications (including knowledge & skills):

  • Ph.D. in Biochemistry or related discipline such as Biological or Physical Science, Biotechnology or Biotechnology Engineering with 10+ years of pharmaceutical industry experience or M.S. with 15+ years of experience
  • Deep understanding of the principles of antibody structure and function, the molecular and biological characteristics that determine their properties and utility as human therapeutics as well as various analytical techniques to measure and quantify these attributes
  • Strong knowledge of biopharmaceutical analytical development for antibody drug substances and drug products
  • Strong understanding of GMP requirements and regulations for clinical and commercial CMC drug development
  • Technical leader with extensive experience across multiple analytical methodologies
  • Proven track record in phase-appropriate analytical method development and validation for drug substance and drug product
  • Experience in setting GMP specifications, control strategies, stability studies, and comparability from early phase to commercialization
  • Excellent knowledge of all regulatory guidelines relevant to GMP work. Experience in all phases of regulatory submissions and interaction with US and international regulatory authorities
  • Experience in managing analytical development activities at CROs and CMOs
  • Strong aptitude to think strategically, with excellent analytical, communication, presentation and writing skills, including extensive experience authoring technical reports and regulatory documents