Work Location: Chester County, Pennsylvania

Summary:

Seeking a Chemical Operator to support the batch-wise manufacture of active pharmaceutical ingredients (APIs) in a cGMP-compliant environment. This role involves hands-on operation of chemical processing equipment, documentation, and collaboration with technical teams to ensure safe and efficient production.

Responsibilities:

• Operate and manipulate chemical processing equipment and reactors to carry out chemical reactions, isolations, and scale-up activities in pilot plant and kilo lab settings.
• Follow batch logs, standard operating procedures, and work instructions to ensure compliance with cGMP and safety regulations.
• Document all production activities accurately, including batch records and process deviations, to maintain regulatory compliance.
• Participate in safety evaluations, process development meetings, and provide feedback to support successful scale-up and process improvements.
• Perform equipment cleaning, maintenance, and assist with hazardous waste removal to ensure a safe and clean working environment.
• Collaborate with technical teams, including chemists and quality assurance, to support the release of raw materials, intermediates, and final products.
• Utilize personal protective equipment, including respirators and appropriate gowning, when handling highly potent compounds and hazardous materials.
• Monitor and respond to abnormal operating conditions, ensuring immediate notification and corrective action as needed.

Qualifications:

• High school diploma or GED required.
• Three or more years of experience as a chemical operator in a GMP-regulated environment; experience with API or drug substance manufacturing highly preferred.
• Mechanical aptitude for operating production equipment and understanding of chemical processes.
• Ability to use computer software applications, including Microsoft Office Suite.
• Experience working with solvents and handling hazardous materials.
• Ability to lift and move up to 50 pounds and handle 55-gallon drums.
• Capable of qualifying for and using respiratory protective equipment.
• Strong attention to detail, documentation skills, and ability to work flexible shifts as needed.

Published Category: Manufacturing & Technical Operations