About The Position

This role is responsible for adhering to GMP requirements and safety standards. The primary focus is the safe and efficient manufacturing of active pharmaceutical ingredients (APIs) according to cGMP requirements. The Associate Production Scientist is a lab-based role supporting and executing activities in the manufacturing environment, including executing production procedures, updating documents, maintaining safety and quality, and other production tasks. The D shift is Thursday-Sunday 6:30pm – 7:00am, then Friday-Sunday 6:30pm – 7:00am. The role requires demonstrating proper lab safety practices and compliance with various regulatory guidelines. It involves operating as a primary operator in cGMP production areas, training secondary operators, drafting deviation reports, utilizing and updating written procedures, mentoring new employees, maintaining safety and cleanliness, communicating production status, and taking ownership of departmental responsibilities.

Requirements

  • Bachelor’s Degree in Chemistry, Biochemistry, Chemical Engineering, or other Life Science discipline.
  • 1+ years of regulated pharmaceutical or chemical production manufacturing experience in an academic or professional setting.
  • Ability to read and understand written protocols.
  • Basic computer literacy (Microsoft Office and Outlook tools, Electronic Document Management Systems, etc.).
  • Effective oral and written communication skills.
  • Basic mathematical skills.
  • Possess a high degree of motivation and self-starter attitude.
  • Ability to multi-task while paying close attention to detail.

Responsibilities

  • Execute existing production procedures.
  • Update supporting documents.
  • Maintain the safety and quality of the manufacturing process.
  • Perform other production tasks as directed.
  • Demonstrate proper lab safety practices and comply with FDA, OSHA, EPA, DNR, DOT, and other regulatory guidelines.
  • Operate as a primary operator in multiple cGMP production areas, including Kilo Labs, and train secondary operators to achieve primary status.
  • Draft preliminary reports on deviations from procedures, identifying potential contributing factors.
  • Utilize and update written procedures, including operation and batch records, with assistance from supervisors.
  • Mentor new employees through technical and on-the-job training, fostering a collaborative team environment.
  • Maintain safety and cleanliness in production areas, focusing on potent compound handling techniques and proper PPE usage.
  • Communicate production status effectively using shift pass-off tools and computer systems, while addressing safety and process issues promptly.
  • Take ownership of departmental responsibilities, providing support through additional tasks as directed by leadership.

Benefits

  • health insurance
  • paid time off (PTO)
  • retirement contributions
  • other perquisites
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