CMC (Biologics Manufacturing) Project Manager

Location
San Diego, CA, US
Posted
Oct 15, 2019
Ref
42082
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
The Project Manager is responsible for providing chemistry, manufacturing and control (CMC) project management for one or more of AnaptysBio's novel therapeutic antibody development programs. The objective of this role is to advance the development of therapeutic antibodies to clinical trials according to established timelines. Responsibilities include implementing, managing and providing operational support of manufacturing activities conducted at external CMOs. This individual is responsible for tracking CMC-related reports and documentation, budgets, invoices and assist with regulatory filings.

This position reports to the Vice President, Project Management

Requirements

  • BS/MS degree in bioprocessing or biological sciences
  • Five years' related experience in the biotechnology or pharma industry with a primary focus on process development, GMP manufacturing operations and other related CMC activities
  • Demonstrated experience managing CMC project deliverables, scope, and timeline to ensure the project remains on schedule and within scope.
  • Demonstrated ability to identify and analyze project risks and help guide teams to develop appropriate mitigation strategies
  • Experience working with project management methodologies including project planning, budget development, project management software
  • Knowledge of GMP and Quality systems