Skip to main content

This job has expired

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

CMC Manager (External Manufacturing)

Employer
AnaptysBio, Inc.
Location
San Diego, CA, US
Start date
Oct 25, 2019

View more

Discipline
Manufacturing & Production, Manufacturing/Mechanical
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach
Send job

Job Details

The CMC Manager supports early to late stage biologics drug process development, technical transfer, GMP product quality management, supply chain activities at external Contract Manufacturing Organization (CMO) and Contract Testing Labs (CTL) to ensure on-time and in-full deliveries. The individual will also work with internal cross-functional departments (R& D, Program Management, Quality Assurance, and CMC Process & Analytical Development) including oversight of process validation and GMP documentation, process performance and analytical trending, investigations, change controls, GMP product batch disposition.

This position reports to the head of Manufacturing

Requirements

  • Theoretical knowledge typically achieved through a related four-year college experience, such as a Bachelor's degree in life-sciences, medical-related sciences or chemical or biomedical engineering
  • 8 years of relevant biological process development & manufacturing, external GMP Product Quality management experience in the pharmaceutical industry, preferably manufacturing of vaccines or other biologics.
  • Considerable experience in Project/Program Management (PM) related to drug development and to development and implementation of methods to manufacture drugs/biologics, including changes to Operations/Manufacturing and Chemistry, Manufacturing, and Controls (CMC).
  • Demonstrated ability to simultaneously manage multiple projects, and to function in a collaborative team environment.

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