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Quality Control Chemistry Manager

Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 12, 2022

Job Description:

Overview Summary: The Quality Control Chemistry Manager, under general supervision, will be responsible for planning, organizing, directing, and evaluating routine activities of the QC staff as well as overseeing all raw material testing and release for use in GMP production. - The Chemistry Manager will lead tech transfer activities of qualified analytical methods from designated donor laboratories. - The Chemistry Manager will play a pivotal role in selecting qualified personnel to staff the QC chemistry laboratory. - - External US Essential Functions:

  • Manage the QC Chemistry Staff, including hiring, supervision, coaching, mentoring, discipline, and performing annual review assessments.
  • Coordinate and oversee QC analytical testing for GMP batch release and stability testing.
  • Coordinate and oversee Method Qualification / Validation activities
  • Ensure QC equipment is maintained in a qualified GMP state.
  • Prepare, review 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.
  • Participate in client calls and meetings as technical SME
  • Assist in developing and managing QC Chemistry budget / headcount as needed
  • Review and approve data / reports during release & stability testing.
  • Ensures laboratory compliance to established specifications and procedures.
  • Report excursions/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 using Trackwise.
  • Perform other duties as assigned. -Required Skills & Abilities:
    • Sound understanding of analytical instrumentation and methodologies. Such as chromatography, electrophoresis, and spectrophotometry.
    • Operate as a team leader, coordinate staff scheduling and training.
    • Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
    • Utilize SDS 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. -Working Conditions & Physical Requirements:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. - Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. - While performing the duties of this job, the employee is regularly required to:
      • Experience prolonged standing, some bending, stooping, and stretching.
      • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
      • Ability to sit for long periods to work on a computer.
      • Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
      • Ability to wear personal protective equipment including safety glasses, lab coat, and gloves.
      • Attendance is mandatory. -Minimum Qualifications:
        • Master's degree with at least six (6) years' industry experience in a GMP / GxP, or a comparable federally regulated environment, of which two (2) years are in a shift / team lead, supervisory or managerial role. -
        • Bachelor of Science degree with at least eight (8) years' industry experience in a GMP / GxP, or a comparable federally regulated environment, of which two (2) years are in a shift / team lead, supervisory or managerial role. -Preferred Qualifications:
          • Chemistry or Biochemistry major.
          • Analytical laboratory experience in a GLP/GMP regulated environment is preferred.
          • Experience in Empower 3.0
          • Experience in Trackwise Deviation Management software.
          • Familiar with Monoclonal Antibodies / Gene Therapy testing panelsWe are an equal opportunity and affirmative action employer. - All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. -If an accommodation to the application process is needed, please e-mail .

Keywords: FDBT - FUJIFILM Diosynth, College Station , Quality Control Chemistry Manager, Executive , College Station, Texas

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