Associate Director/Director, Quality Assurance (Antibody Quality Operations)

Location
Hayward, California
Posted
Jun 09, 2021
Ref
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Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Job Summary:

This individual will be responsible for providing quality oversight and support for Arcus’ antibody programs.

Responsibilities: 

  • Responsible for the review of master batch records, executed batch records, and the management of process related issues (from investigation to closure). 
  • Responsible for managing process related Deviations, CAPAs, change control, product complaints, and the maintenance of the lot genealogy system.  
  • Work with the CMC teams for proper archival of all CMC related documents into Arcus’ electronic data management system.
  • Monitor quality performance at CDMOs to drive continuous improvement.
  • Provide Quality Support throughout the lifecycle of a product (development, process characterization, scale up, process performance qualification activities, tech transfer activities, and decommissioning).
  • Partner with several other functional areas (e.g., Development, Manufacturing, Clinical, Analytical Sciences, Regulatory, etc.) to ensure that our antibody development and manufacturing activities are aligned to maintain highest quality standards.
  • Lead cross functional product specific team meetings to ensure product quality issues are addressed in a timely manner.
  • Provide quality guidance cross functionally to ensure compliance with cGMPs requirements and internal Arcus guidelines.
  • Manage the life cycle (generation and periodic review) of Quality Agreements generated for CDMOs.
  • Support regulatory filings and inspections (partner and health authority audits)
  • Leads joint Quality team meetings with CMOs
  • Other duties as assigned.

 Qualifications:

  • BSc. in Biological or Physical Science, Biotechnology or Biotechnology Engineering with 15+ years of pharmaceutical industry experience or M.S. with 10+ years of experience
  • Working knowledge with the principles of antibody structure and function, the molecular and biological characteristics that determine their properties and utility as human therapeutics.
  • Working knowledge of various analytical techniques used to measure and quantify product quality attributes.
  • Working knowledge of antibody development and manufacturing processes (drug product/drug substance). 
  • Strong understanding of GMP requirements and regulations for clinical development and commercial manufacturing
  • Ability to work under accelerated timelines. Can perform timely review of drug substance and drug product batch records under abbreviated timelines.
  • Ability to manage and work with CMOs to drive Arcus’ goals and timelines.
  • Direct experience supporting regulatory filings (i.e., IND, IMPD, and BLA)
  • Proven track record in phase-appropriate manufacturing support for drug substance and drug product manufacturing.
  • 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
  • Poses an aptitude to think strategically. Has excellent communication, presentation and writing skills.


Arcus Biosciences is an equal opportunity employer.