Senior Bioprocess Associate - Devens MA

Military Spouse Corporate Career Network•Devens, MA

10d•Onsite

About The Position

The Senior Bioprocess Associate uses current Good Manufacturing Practices (cGMPs) to execute commercial manufacturing processes for therapeutic proteins used in medicines that treat serious diseases. The role performs moderately complex routine manufacturing assignments using written procedures and minimal instructions, while recognizing deviations from accepted practices. The associate operates production equipment, supports process automation and business systems, maintains production records, and helps ensure regulatory compliance and a clean room environment. The role also contributes to document revisions, process-related investigations, inventory management, batch-report review, and work-safety initiatives.

Requirements

High school diploma required.
At least 2 years of process operations experience in a biotechnology manufacturing facility subject to GMP regulations.
Practical knowledge of GMP regulations and company Standard Operating Procedures.
Demonstrated proficiency with common computer tools, including word processing, spreadsheet, and web-based applications.
Prior work experience requiring attention to detail and personal accountability.
Experience participating successfully in work teams where accountability, attention to detail, collaboration, and results were expected.
Good interpersonal skills; attentive and approachable; able to maintain professional and productive relationships with area management and coworkers.

Nice To Haves

Knowledge of science generally attained through a bachelor's degree in science, engineering, biochemistry, or a related discipline, or equivalent; desired but not required.

Responsibilities

Perform routine, moderately complex manufacturing assignments according to written procedures and recognize deviations from accepted practice.
Adhere to Good Manufacturing Practices and standard operating procedures.
Revise and create process documents, including SOPs and batch records, and assist with process-related investigations.
Train to proficiency in process automation, supporting business systems, and primary production equipment in 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 work-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 process automation systems such as Delta V, Syncade Interactions, and OSI/Pi Historian, as well as supporting 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.