GMP KILO LAB OPERATIONS SCIENTIST - South Plainfield New Jersey

Company: Porton Pharma Solutions Ltd.
Location: South Plainfield, New Jersey
Posted On: 11/20/2024

Job Title: GMP Operations ScientistLocation: 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). More...

        

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