Chemical Operations Scientist - GMP (BS in Chemistry)

Job Title: Chemical Operations Scientist-GMP

Location: Onsite, Cranbury/South Plainfield, NJ

Position Type: Full-Time

Reports To: Sr. Director of GMP Kilo Lab Operations

Job Summary:

We are seeking a detail-oriented and motivated GMP Operations Scientist to join our South Plainfield site GMP Kilo Lab Operations department within the CDMO (Contract Development and Manufacturing Organization) industry. The ideal candidate will have a background in GMP processes, knowledge of scale-up operations and experience in the pharmaceutical industry.

Key Responsibilities:

• GMP Operations: Execute GMP operations in the Kilo Lab, including the writing, execution, and documentation of batch records for the production of intermediates and active pharmaceutical ingredients (APIs).
• Scale-Up Activities: Support the scale-up of processes from laboratory to kilo scale, ensuring compliance with regulatory standards and internal quality requirements.
• Clean GMP equipment and suites following proper cleaning verification protocols. Perform PM and calibrations as needed.
• Regulatory Compliance: Ensure all activities adhere to GMP guidelines and SOPs, maintaining a high standard of quality throughout the manufacturing process.
• Data Management: Document and analyze production data, preparing reports and summaries for internal and external stakeholders.
• Troubleshooting: Identify and resolve operational issues, implementing corrective and preventive actions as necessary.
• Training and Development: Will be trained on GMP practices, safety protocols, and operational procedures.
• Maintain good documentation practices.

Qualifications:

• Bachelor’s or Master’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.
• Understanding of GMP regulations and industry best practices.
• Proven track record of setting and meeting targets and timely execution of objectives.
• 1 year of experience in GMP operations within the pharmaceutical or CDMO industry, specifically in a kilo lab setting, is a plus.
• Experience with process scale-up and equipment used in kilo lab operations (e.g., reactors, filtration systems) is a plus.
• Good problem-solving skills and attention to detail.
• Strong communication and teamwork skills, with the ability to collaborate effectively across departments.
• Ability to perform the physical requirements of the position. Must be able to walk, stand, crawl, stoop, crouch, bend or reach above shoulders frequently. This job requires twisting and turning of the body and the use of both hands.