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Katalyst Healthcares & Life Sciences

Manufacturing Associate - Biotech Job at Katalyst Healthcares & Life Sciences in

Katalyst Healthcares & Life Sciences, Walkersville, MD, US

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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.