Senior Bioprocess Associate - Devens MA
About The Position
The Senior Bioprocess Associate uses current Good Manufacturing Practices (cGMPs) to execute commercial manufacturing processes that produce therapeutic proteins used in medicines for serious diseases. The role performs moderately complex routine manufacturing assignments under written procedures with minimal instructions and requires recognizing deviations from accepted practice. It operates production equipment and process automation systems, maintains production records and a clean room environment, and supports process documentation, investigations, inventory, and workplace safety.
Requirements
- Experience using or adhering to current Good Manufacturing Practices (cGMPs) and standard operating procedures.
- Ability to perform moderately complex routine manufacturing assignments with minimal instructions and recognize deviations from accepted practice.
- Ability to operate production equipment and use process automation and supporting business systems, or train to proficiency in them.
Responsibilities
- Perform routine, moderately complex manufacturing assignments according to written procedures and recognize deviations from accepted practice.
- Adhere to cGMPs and standard operating procedures.
- Revise and create process documents, including SOPs and batch records, and assist with process-related investigations.
- Train for proficiency in process automation, supporting business systems, and primary production equipment within the assigned functional area.
- Operate primary production equipment, such as bioreactors, chromatography skids, and media or buffer preparation equipment, as instructed.
- Lead efforts to maintain material and component inventory levels.
- Support a safe work environment and contribute to area-specific safety initiatives.
- Weigh and check raw materials; assemble, clean, and sterilize process equipment; and monitor processes.
- Complete work instructions and maintain a clean room environment in compliance with regulatory requirements.
- Use in-process automation systems, including Delta V, Syncade Interactions, and OSI/Pi Historian, as well as supporting business systems such as SAP, Trackwise, and Maximo, to maintain production records.
- Assist with reviewing batch and exception reports for each manufacturing lot with a supervisor and Quality representative.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
