Manufacturing Associate I

Celldex Therapeutics Fall River , MA 02722

Posted 2 months ago

Overview

If you want to work in biotech / pharmaceutical manufacturing in a small team environment with a great group, this is an opportunity you'll want to explore!

The Manufacturing Associate is responsible for performing all activities within the production facility to produce biopharmaceutical products.

Celldex Therapeutics, Inc. is developing a pipeline of immunotherapy and targeted cancer therapies. We are conducting clinical trials across multiple product candidates.

Responsibilities

  • Perform and document routine procedures following written instructions (SOP's, batch records, solution documents, protocols, etc.) in compliance with regulatory guidelines

  • Maintain, prepare and clean manufacturing areas, equipment, lab-ware and materials

  • Prepare solutions, media and other process related items in support of manufacturing processes

  • Collect in-process samples for pH, conductivity and temperature, etc. in support of manufacturing processes

  • Operate manual, semi-automated and automated equipment used for the production of biopharmaceuticals in cell culture and harvesting

  • Support in the commissioning/start-up and validation of process equipment and Engineering runs

  • Troubleshoot equipment and manufacturing processes

  • Assist in the investigation of environmental excursions and deviations

  • Assist with product changeover

  • Write and revise SOPs, Master Batch Records and other manufacturing GMP documentation

  • May assist in review of GMP documentation

Qualifications

  • Demonstrate mechanical aptitude and good manual dexterity

  • Ability to work and to stand for long periods and lift 30 - 40 pounds

  • The ability to work in a clean room environment with good aseptic technique

  • Ability to read, write, understand, and work from SOP

  • Word processing ability including Microsoft Word, Excel, PowerPoint, and Outlook

  • The ability to work independently and as part of a team

Education/Experience:

  • A.S/B.A/B.S. in Biology or related field

  • 0-2 years of experience in Biotech/Pharma industry.

  • Availability to work weekends, holidays and extended/second shift when operation is implemented

  • Aseptic technique, experience culturing CHO cells and monoclonal antibodies, and knowledge of GMPs a plus

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Manufacturing Associate I

Celldex Therapeutics