Celldex Therapeutics

Quality Control (QC) Analyst, Biotech - Fall River, MA

US-MA-Fall River

Overview

As a Quality Control (QC) Analyst II/III at Celldex Therapeutics, you’ll be responsible for everything associated with routine and non-routine lab work assigned by departmental management and with minimal supervision at our Fall River MA facility.

 

If you have laboratory experience in the biotechnology / pharmaceutical industry and want to work in a small team environment with a great group, this is an opportunity you’ll want to explore!

 

Celldex Therapeutics, Inc. is developing a pipeline of immunotherapy and targeted cancer therapies. We are conducting clinical trials across multiple product candidates, including a registration study in triple negative breast cancer.

Responsibilities

  • In-process and release testing to support manufacturing; release and stability testing on finished product according to product specifications, SOPs, stability protocols, and USP / EP.
  • Operate complex instrumentation, including maintenance and troubleshooting.
  • Checks/reviews data generated by routine and non-routine analysis and finalize data reports using appropriate computer systems.
  • Perform routine and non-routine projects independently and compile accompanying reports and/or data summaries; database entry for trending programs and data filing; and create and edit SOPs.
  • Assist in training new and junior employees.
  • Perform inventory of laboratory chemicals and supplies and order supplies.
  • Independently identifies problems with proposed solutions, actions and/or experimental designs.

Qualifications

Required Skills:

  • Strong working knowledge of raw material testing, microbiological assays, cIEF, CE-SDS, ELISA, cell-based and HPLC assays, as well as method transfer experience.
  • Knowledge of analytical equipment and the associated software.
  • Highly adaptable to rapid change.
  • Availability to perform testing work outside normal working hours, as business requires (including evenings, weekends and holidays).

 

Required Education/Experience:

  • Completed Bachelor’s degree in Biology, Chemistry, or related discipline.
  • A minimum of 3 years of working experience in the biotech / pharmaceuticals industry, including hands-on experience in a cGMP laboratory and familiarity with standard concepts, practices, procedures, instrumentation and software in a Quality Control organization.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Need help finding the right job?

We can recommend jobs specifically for you! Click here to get started.