Manufacturing Associate - Biotech

Responsibilities: The Manufacturing Associate is responsible for the manufacture of therapeutic proteins (API) in compliance with current Good Manufacturing Practices (cGMP). This entry-level role involves executing production processes, operating, and monitoring equipment, performing basic laboratory tasks, handling materials, and maintaining cleanliness and organization within manufacturing areas. Associates will develop foundational cGMP knowledge and aseptic techniques while working under close supervision, progressively building autonomy in assigned responsibilities. Key tasks include setting up and operating manufacturing equipment, performing clean-in-place (CIP) and steam-in-place (SIP) procedures, completing accurate documentation, supporting routine sanitization, and collaborating with cross-functional teams. This position plays a vital role in ensuring safe, compliant, and efficient production of life-saving biopharmaceutical products. Required Skills: Ability to set up, operate, and monitor production equipment and processes, including CIP and SIP systems. Basic laboratory skills, including measuring pH, conductivity, and handling in-process samples Understanding of GMP principles and Good Documentation Practices (GDP). Capability to accurately complete batch records and documentation. Willingness and ability to perform material handling and transfer activities. Strong attention to detail and ability to follow written procedures precisely. Commitment to maintaining cleanliness and compliance in manufacturing areas, including routine cleaning and sanitization. Critical thinking and problem-solving skills. Effective communication skills and ability to work collaboratively in a team environment. Flexibility to work second shift and occasional overtime as needed. Physical ability to stand for extended periods, lift up to 50 lbs, and work in a cleanroom environment. Preferred Skills: Prior experience in pharmaceutical, biotechnology, or other GMP-regulated manufacturing environments. Familiarity with cleanroom protocols and aseptic techniques. Experience operating bioprocessing equipment (bioreactors, chromatography skids, filtration systems). Knowledge of 6S principles and continuous improvement initiatives. Basic computer literacy for email communication and electronic documentation. Education: High School Diploma or equivalent required Associate's or Bachelor's degree in a science-related discipline (e.g., Biology, Chemistry, Biotechnology, Engineering) preferred.

Created: 2025-09-27