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.
Qualifications
· Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field is required.
· Experience in pharmaceutical manufacturing, chemical production, or other regulated industries is preferred.
· Knowledge of GMP, GLP, and FDA/EMA regulatory requirements is an advantage.
· Recent graduates with strong academic backgrounds in chemistry or related fields are encouraged to apply.
· Strong understanding of chemical principles and laboratory techniques.
· Ability to follow detailed instructions and complete precise documentation.
· Excellent problem-solving and analytical skills.
· Effective communication and teamwork abilities.
· Commitment to safety and compliance in a regulated environment.
· Willingness to work rotating shifts (day/night/weekend).
Company DescriptionWilmington PharmaTech is a rapidly growing CRO/CMO serving the pharmaceutical industry.
Company Description
Wilmington PharmaTech is a rapidly growing CRO/CMO serving the pharmaceutical industry.