What are the responsibilities and job description for the GMP Operations Scientist position at J-STAR Research, Inc.?
Job Title: GMP Operations Scientist
Location: Onsite, Cranbury, 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 Cranbury site GMP Kilo Lab Operations department within the CDMO (Contract Development and Manufacturing Organization) industry. The ideal candidate will have background in GMP processes, knowledge of scale-up operations and experience in pharmaceutical industry.
Key Responsibilities:
• GMP Operations: Execute GMP operations in the Kilo Lab, including the review, 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 the GMP equipment and room following cleaning verification protocols. Perform PM and calibration 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: To be trained on GMP practices, safety protocols, and operational procedures.
Qualifications:
• Bachelor’s or Master’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.
• 1 year of experience in GMP operations within the pharmaceutical or CDMO industry, specifically in a kilo lab setting.
• Understanding of GMP regulations and industry best practices.
• 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.