Skip to main content

This job has expired

You will need to login before you can apply for a job.

Associate Director, Project Manager, CMC Biologics

Employer
AnaptysBio, Inc.
Location
San Diego, CA, US
Start date
Nov 13, 2019

View more

Discipline
Science/R&D, Biotechnology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach
Send job

Job Details

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

Company

AnaptysBio is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics. We are developing immune cell modulators, including two checkpoint agonists in clinical-stage development, for autoimmune and inflammatory disease: rosnilimab, our PD-1 agonist program in a Phase 2 trial for the treatment of moderate-to-severe rheumatoid arthritis; and ANB032, our BTLA agonist program, currently in a Phase 2b trial for the treatment of moderate-to-severe atopic dermatitis. Our preclinical immune cell modulator portfolio includes ANB033, an anti-CD122 antagonist antibody for the treatment of autoimmune and inflammatory diseases. In addition, AnaptysBio has developed two cytokine antagonists available for out-licensing: imsidolimab, an anti-IL-36R antagonist, in Phase 3 for the treatment of generalized pustular psoriasis, or GPP, and etokimab, an anti-IL-33 antagonist for the treatment of respiratory disorders that is Phase 2/3 ready. AnaptysBio has also discovered multiple therapeutic antibodies licensed to GSK in a financial collaboration for immune-oncology, including an anti-PD-1 antagonist antibody (Jemperli (dostarlimab-gxly)), an anti-TIM-3 antagonist antibody (cobolimab, GSK4069889) and an anti-LAG-3 antagonist antibody (GSK4074386).

Our corporate vision is to transform patient health by delivering innovative immunology therapeutics. Find out more about us by following us on Twitter.

 

CONNECT

Twitter  

Company info
Website
Phone
858-362-6295
Location
10770 Wateridge Circle
Suite 210
 San Diego
California
92121
United States
Send job

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert