Director/Senior Director Antibody Drug Product Development

Hayward, California
Jun 09, 2021
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Locations: Hayward, California | Brisbane, California | Remote, United States

Job Responsibilities:

  • Responsible for all drug product aspects leading process design, tech transfer, and implementation of aseptically filled liquid antibody drug product processes at Arcus’ CMO
  • Provide technical and scientific support to CMOs for routine clinical and commercial drug product manufacturing activities
  • Design and deliver a successful process validation campaign utilizing contemporary risk assessment and control strategy frameworks as established in various regulatory guidelines
  • Author/review technical reports, data summaries and CMC related documents required for regulatory submissions. Author and defend relevant Module 3 sections of global regulatory submissions
  • Enable successful licensure for commercial drug product manufacture by preparing for and providing technical oversight and support for pre-approval inspections
  • Establish framework for routine commercial manufacturing employing continued process verification principles to deliver consistent product profile
  • Partner with 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):

  • D. in Chemical or Biochemical Engineering or relevant discipline with 10+ years of pharmaceutical industry experience or M.S. with 15+ years of experience
  • Proven track record in managing and leading antibody programs through formulation/co-formulation development, process characterization and validation in support of product licensure and commercialization
  • Deep subject matter expertise in antibody drug product manufacturing aspects including formulation, fill, finish, packaging, transportation, and stability and impact of process parameters, raw materials, equipment and product handling on product quality
  • Strong understanding of GMP requirements and regulations for clinical and commercial CMC drug development
  • Experience in establishing the integrated control strategy, setting process validation criteria and GMP specifications, in process controls, process monitoring, and comparability approaches from early phase to commercial
  • 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 development and manufacturing 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