Manufacturing Manager

2 weeks ago


Vacaville, California, United States Polaris Pharmaceuticals Inc. Full time
Job Title: Manufacturing Manager - Upstream

At Polaris Pharmaceuticals Inc., we are seeking a highly skilled Manufacturing Manager - Upstream to oversee the manufacturing of upstream microbial culture to harvest process and intermediates while ensuring compliance with cGMP and GDP regulations.

Key Responsibilities:
  • Develop and implement manufacturing plans to meet production goals and ensure cGMP compliance.
  • Manage and support the manufacturing of upstream microbial (E. coli) culture and intermediates.
  • Collaborate with cross-functional teams, including Quality Control, Facilities, MSATs, and Quality Assurance, to coordinate scheduling and execution of multiple activities.
  • Communicate with vendors regarding raw materials or services.
  • Perform inventory cycle counts and site fit-for-use inspections.
  • Develop and maintain Standard Operating Procedures (SOPs), batch records, and associated protocols under a change control program.
  • Perform final review of batch records, deviations, and change controls.
  • Investigate and resolve deviations, and implement Corrective Action Preventive Action (CAPA) as necessary.
  • Perform performance reviews and provide coaching and development opportunities for manufacturing team members.
  • Organize and lead manufacturing team meetings and represent the manufacturing department during internal or external audits.
  • Screen and interview manufacturing applicants and train manufacturing managers with similar role responsibilities.
Requirements:
  • Bachelor's or Master's degree in a biological science or engineering field.
  • Minimum 5 years of relevant work experience in cGMP manufacturing and/or management.
  • Strong understanding of manufacturing processes and equipment operation.
  • Excellent communication, organizational, and leadership skills.
  • Ability to work independently and as part of a team.
What We Offer:

Polaris Pharmaceuticals Inc. offers a competitive salary and benefits package, as well as opportunities for professional growth and development.


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