Principal Scientist/Senior Scientist, Antibody Analytical Sciences (Product Characterization)

Location
Remote, United States
Posted
Dec 19, 2021
Ref
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Required Education
Masters Degree/MBA
Position Type
Full time

Locations: Remote, United States | Brisbane, California

Responsibilities
 

  • Responsible for broad analytical aspects of Arcus’ antibody programs with emphasis on product and impurity characterization
  • Ensure phase appropriate antibody product characterization using state-of-the-art biochemical and biophysical characterization assays leveraging internal and external (CMO/CRO) resources.
  • Provide broad analytical inputs for process and product characterization, specification setting, and establishing stability and comparability strategies to enable successful regulatory submissions
  • Partner with several other functional areas (e.g., Development, Manufacturing, Clinical, Quality, Regulatory, etc.) to ensure our antibody development and manufacturing activities are always aligned with the highest quality standards (including cGMP compliance) and overall corporate objectives

 

Qualifications
 

  • Ph.D. in Biochemistry or related discipline such as Biological Science, Biotechnology, Chemical or Biochemical Engineering with 5+ years of pharmaceutical industry experience or M.S. with 9+ years of experience or B.S. with 11+ years of experience for Principal Scientist (Ph.D. with 3+ years of pharmaceutical industry experience, M.S. with 5+ years of experience or B.S. with 9+ years of experience for Senior Scientist position)
  • 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 including method qualification and validation
  • Technical leader with extensive experience in biologics/antibody product and impurity characterization using biochemical and biophysical methodologies such, HPLC, CE, LC-MS, AUC, SEC-MALS, FTIR, CD etc.
  • Experience in setting GMP specifications, control strategies, stability studies, and comparability from early phase to commercialization. 
  • Excellent knowledge of all regulatory guidelines relevant to product characterization. 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, problem-solving skills
  • Excellent communication, presentation and writing skills, including extensive experience authoring technical reports and regulatory documents as well as responding to agency questions (RTQs)

 
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