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Manufacturing Supervisor (Second Shift)

Company: GeminiBio
Location: West Sacramento
Posted on: January 13, 2022

Job Description:

Company ProfileFounded in 1985, Gemini Bioproducts, LLC ("Gemini Bio") is a leading supplier of cell culture media, sera, and reagents and cellular analysis instrumentation to many of the top research and academic institutions as well as biotechnology, cell/gene therapy, and pharmaceutical companies. In 2018 Gemini Bio became a portfolio company of BelHealth Investment Partners, LLC, a Fl-based healthcare private equity firm. Gemini Bio is now under new leadership and operates in West Sacramento, California. Gemini Bio is growth-focused and is expanding and enhancing its manufacturing capabilities driving toward higher quality and compliance standards commensurate with the needs of the commercial therapeutic space. Gemini Bio is augmenting its product portfolio through acquisitions, internal innovation, and partnerships.
Position SummaryThe supervisor position is responsible for implementing and supervising daily activities in a specific production area to ensure manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (GMPs), environmental health and safety (EHS) guidelines and any other regulations that could apply.
Reports to Sr Director of Manufacturing
Key Responsibilities

  • Supervise the daily manufacturing operations in an area. Maintain (audit, refine, improve) equipment and processes within this area.
  • Provide a positive and equitable working environment emphasizing respect, responsiveness, and results.
  • Support and emphasize the Safety and Quality commitments of the department. Make decisions concerning these commitments within the area.
  • Responsible for timely execution and review of processing batch records and related manufacturing documents for the release of the final product.
  • Ability to utilize resources in the most efficient and productive manner possible.
  • Provide advanced problem solving and troubleshooting in case of any event during manufacturing activities. Acts as a resource to manufacturing staff during working hours.
  • Supervise and train team members to maintain competency in manufacturing procedures, GMP, gowning requirements, aseptic techniques, and other regulatory and safety standards.
  • Ensure timely initiation of documentation for non-conformance, deviations, and CAPAs. Escalation to management and interaction with other stakeholders when needed.
  • Write, revise, and execute technical standard operating procedures, processing batch records, and other required documents.
  • Responsible for equipment and manufacturing facility. Review and ensure accurate cleaning logs. Assist with coordination with Quality, Facilities, and EH&S to resolve facility issues and schedule maintenance and outages.
  • Commit to employee feedback and developmental process - support Talent Management goals, conduct recognition and disciplinary action for employees, facilitate employee representation throughout the organization.
  • Submit and/or maintain and distribute reports related to attendance, labor, efficiency, safety, scrap and others as needed.
  • Find opportunities for improvement in manufacturing efficiency and compliance while assisting with investigations/deviations and change controls.
  • Collaborate with Development team to transfer new procedures GMP manufacturing.
    Company Values
    • Confident
    • Adaptable
    • Results driven
    • Reliable
    • Innovative
    • Ethical
    • DecisiveRequired Skills and Experience
      • The ideal candidate will have a bachelor's degree in life sciences or related industry experience.
      • 3+ years experience with cGMP biologics manufacturing, previous leadership experience preferred.
      • Advanced understanding and experience with manufacturing to filling, and aseptic processing.
      • Excellent communication, written and verbal, and strong organizational and time management skills.
      • Strong interpersonal skills and very resourceful
      • Knowledge of cGMP/FDA regulations, quality standards, documentation, and practices.
      • Ability to perform physical tasks requiring dexterity and mobility. Daily tasks call for routine walking, standing in cleanroom environments, and occasional lifting of heavy materials.

Keywords: GeminiBio, West Sacramento , Manufacturing Supervisor (Second Shift), Hospitality & Tourism , West Sacramento, California

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