Manufacturing Associate I

1 week ago


Vacaville, California, United States Polaris Pharmaceuticals Inc. Full time
About the Role

Polaris Pharmaceuticals Inc. is a leading biopharmaceutical company dedicated to the development and manufacturing of high-quality drug substances and products.

Key Responsibilities
  • Perform daily Good Manufacturing Practice (GMP) production operations in the cleanroom and Aseptic Fill Suite (AFS)
  • Support production activities, including cleaning, autoclave, and parts wash
  • Collaborate with the production leadership team, Manufacturing Science and Technology (MSAT), Quality Assurance, and Scheduling to meet short and medium-term objectives
  • Escalate issues as needed and drive a culture of continuous improvement
  • Develop area technicians in both expertise and production knowledge
  • Comply with current Good Manufacturing Practice (cGMP) and Good Distribution Practice (GDP) regulations
  • Order and dispense raw materials
  • Perform inventory cycle counts and site fit-for-use inspections
  • Develop and maintain Standard Operating Procedures (SOPs), batch records, and associated protocols
  • Investigate and resolve deviations, and implement Corrective Action and Preventive Action (CAPA)
  • Maintain Polaris' right-to-operate by ensuring cGMP production of products in compliance with all applicable Health Authority requirements and Polaris' Quality Management System
  • Ensure systems and processes are properly maintained to ensure staff's safety, product quality, and continuity of supply
  • Ensure staff are appropriately trained and qualified for the activities they perform prior to execution
  • Work overtime as needed to meet business requirements
Requirements
  • Bachelor's degree in Life Sciences or engineering, or equivalent experience
  • Knowledge of large molecule biopharmaceutical manufacturing processes and equipment
  • Ability to work on-site full-time as required
  • Ability to lift and carry up to 40 pounds
  • Ability to stand for prolonged periods operating manufacturing equipment, including in an ISO5 cleanroom
What We Offer

Polaris Pharmaceuticals Inc. offers a dynamic and challenging work environment, with opportunities for professional growth and development. We are committed to the well-being and safety of our employees, and provide a comprehensive benefits package, including health insurance, retirement plan, and paid time off.



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