Associate Director, Project Manager, CMC Biologics

Location
San Diego, CA, US
Posted
Oct 15, 2019
Ref
149984
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

The candidate in this position is responsible for providing chemistry, manufacturing and control (CMC) project management for one or more of AnaptysBio's novel therapeutic antibody development programs. Responsibilities will include the implementation, management and operational support of manufacturing activities conducted at external CMOs and supporting the internal CMC project teams to progressively advance the development of therapeutic antibodies to clinical trials according to established timelines. This individual will also be responsible for tracking CMC-related reports and documentation, budgets, invoices and assisting with regulatory filings.

Essential Functions
  • Collaborate closely with CMC leadership and team members, to execute the external manufacturing strategies, and ensure development projects achieve key deliverables and progress toward milestones and regulatory filings in alignment with company timelines.
  • Provide project management support and actively manage the relationships, performance and productivity of the external CMOs and/or CROs to extract maximum value from the service provider
  • Provide technical project management and operational support for the internal CMC project teams, schedule and manage joint team meetings with the CMOs, track meeting minutes and actions to completion.
  • Facilitate effective and open communications with assigned project stakeholders.
  • Document and file all reports, process documents, communications conducted with external CMOs or CROs.
  • Provide expert scientific and QC review of CMC section of regulatory documents.
  • In partnership with CMC leadership and contracts manager, implement service agreements with external CMOs and CROs, forecast and track project budgets for external studies, and effectively partner with the Finance group to provide timely reconciliation of actual expenses against project budget.
  • Regularly meet with supervisor and CMC team members to define and align strategies and manage tactical execution.

Requirements

Education & Experience
  • BS/MS degree in bioprocessing or biological sciences
  • Minimum of 10 years related experience in the biotechnology or pharma industry with a primary focus on process development, late stage GMP manufacturing operations and other related CMC activities
  • Demonstrated experience managing CMC project deliverables, scope, 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


Knowledge Requirements
  • Working knowledge of cross-functional drug development processes
  • Working knowledge of CMC development strategies across pre-IND-BLA stages. Knowledge of issues associated with biologics drug development and manufacturing
  • Excellent understanding of project planning techniques and applications
  • Proficiency working with Microsoft Project, Excel, Word and PowerPoint