Job Description

• 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.

• 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.

• 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.

• High School Diploma or equivalent required
• Associate's or Bachelor's degree in a science-related discipline (e.g., Biology, Chemistry, Biotechnology, Engineering) preferred.

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