Production Chemist
Wilmington PharmaTech Company LLC
Job Description
Job Description
Job Summary
We are seeking motivated Production Chemists to join our GMP-compliant pharmaceutical manufacturing team working in both pilot plant and kilolabs. The Production Chemist will be responsible for performing production operations involving chemical processing, batch preparation, and in-process testing to support the manufacture of pharmaceutical products. In addition, the Production Chemist will provide day-to-day supervision and guidance to production operators, ensuring processes are carried out in full compliance with GMP and safety requirements. This position requires strict adherence to cGMP standards, safety regulations, and data integrity practices. The role involves working on a rotating shift schedule, including nights and/or weekends.
Key Responsibilities
- Execute production processes involving weighing, charging, mixing, distillation, and chemical reactions in compliance with SOPs and batch production records.
- Operate and monitor process equipment (reactors, filtration systems, dryers, etc.) according to validated procedures.
- Collect, test, and interpret in-process samples to ensure product quality and batch consistency.
- Maintain accurate, real-time documentation in batch production records, logbooks, and electronic systems to ensure data integrity and regulatory compliance.
- Supervise and support operators during daily production operations, ensuring tasks are performed according to GMP and safety standards.
- Provide on-the-floor technical guidance and troubleshoot issues as needed.
- Adhere to all cGMP, safety, and environmental policies, including proper handling of raw materials, intermediates, and finished products.
- Support cleaning, equipment setup, and line changeover activities as required.
- Assist in deviation investigations, corrective and preventive actions (CAPA), and continuous improvement initiatives.
- Collaborate with Quality Assurance, Engineering, and Maintenance teams to ensure efficient production operations.
- Participate in training programs and maintain qualifications for GMP manufacturing operations.
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