GMP Operations Scientist

Job Title: GMP Operations Scientist
Location: Onsite, South Plainfield, NJ
Position Type: Full-Time
Reports To: Sr. Director of GMP Operations

Job Summary:

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

Key Responsibilities:

• GMP Operations: Execute and oversee GMP operations in the Kilo Lab, including the preparation, 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.
• Process Optimization: Collaborate with cross-functional teams to identify opportunities for process optimization and efficiency improvements in production.
• Quality Assurance: 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 comprehensive reports and summaries for internal and external stakeholders.
• Troubleshooting: Identify and resolve operational issues, implementing corrective and preventive actions as necessary.
• Training and Development: Mentor and train junior staff on GMP practices, safety protocols, and operational procedures.
• Regulatory Compliance: Participate in audits and inspections, ensuring that all GMP operations meet regulatory requirements.

Qualifications:

• Bachelor’s or Master’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.
• 3+ years of experience in GMP operations within the pharmaceutical or CDMO industry, specifically in a kilo lab setting.
• Strong 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).
• Excellent problem-solving skills and attention to detail.
• Strong communication and teamwork skills, with the ability to collaborate effectively across departments.
• Proficient in data analysis and laboratory information management systems (LIMS).