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.
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
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
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