Manufacturing Scientist

We are seeking a detail-oriented and motivated GMP Operations Scientist to join our Cranbury site Manufacturing department. 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 , 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.

Salary : $85,000 - $100,000