QC Supervisor, Chemistry

FUJIFILM Diosynth Biotechnologies-posted 28 days ago
Full-time • Manager
Onsite • College Station, TX
Merchant Wholesalers, Durable Goods
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The Quality Control Chemistry Supervisor, under general supervision, will be responsible for planning, organizing, directing, and evaluating routine activities of the QC Chemistry staff as well as coordinating the installation and qualification of new analytical equipment in support of GMP release and stability testing. The Chemistry Supervisor will lead tech transfer activities of qualified analytical methods from a designated donor laboratory. The Chemistry Supervisor will play a pivotal role in selecting qualified personnel to staff the QC chemistry laboratory. The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles."

  • Supervise and lead the QC Chemistry Staff, including hiring, supervision, coaching, mentoring, discipline, and performing annual review assessments.
  • Coordinate QC analytical testing for GMP release and stability testing.
  • Ensure QC equipment is maintained in a qualified state.
  • Prepare and execute tech transfer, qualification and validation protocols and reports as needed.
  • Write, revise, and review Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation.
  • Establish a system for managing test samples, reagents and reference standards.
  • Review and approve data / reports during release & stability testing.
  • Ensures laboratory compliance to established specifications and procedures.
  • Reports excursion/out of specifications results and conducts investigations as needed.
  • Assure the implementation of appropriate and timely corrective actions.
  • Work closely with Quality Assurance and other departments to continuously improve the effectiveness of the Quality Management team.
  • Work collaboratively with manufacturing and product development teams to improve quality, increase efficiency, solve problems, generate cost savings, and provide new product support.
  • Interface with current and potential clients as well as interface with investigators during internal and external inspections.
  • Follow all established laboratory, regulatory, safety, and environmental procedures.
  • Identify deviations and report possible preventative and corrective actions.
  • Perform other duties as assigned.
  • Sound understanding and knowledge of SEC, UPLC, and Capillary Electrophoresis instrumentation and methodologies.
  • Operate as a team leader, coordinate staff scheduling.
  • Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
  • Utilize MSDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
  • Develop staff to maximize contributions to team and company.
  • Ability to multi-task and prioritize work assignments with little supervision.
  • Excellent attention to detail.
  • Computer proficiency required.
  • Ability to accurately review and complete required documentation.
  • Excellent written and oral communication skills.
  • Excellent organization and analytical skills.
  • Role model for company core values of trust, delighting our customers, and Gemba.
  • Master's degree preferably in Chemistry or Biochemistry with 3+ years of industry experience in a GMP / GxP or a comparable federally regulated environment of which 2+ years are in a lead or supervisory role; OR,
  • Bachelor's degree preferably in Chemistry or Biochemistry with 5+ years industry experience in a GMP / GxP or a comparable federally regulated environment of which 2+ years are in a lead or supervisory role.
  • Analytical laboratory experience in a GLP/GMP regulated environment is preferred.
  • Experience in Trackwise Deviation Management software.
  • Experience in Empower 3 software.
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