QC Manager, Chemistry

Overview

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki. 

External US

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

 

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.  

 

Reports to                Director, QC

Work Location         College Station, TX 

 

Primary Responsibilities:

• 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.
• 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.
• Coordinate and oversee all raw material testing (internal and external) in adherence to approved material specifications.
• Serve as QC lead during project team meetings.
• Participate in client calls and meetings.
• Release raw materials from quarantine using SAP.
• Assist in developing and managing QC Chemistry budget.
• 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.

 

Qualifications:

• Master’s degree with 5+ years of industry experience in a GMP/GxP, or a comparable federally regulated environment.  
• Bachelor’s degree with 7+ years industry experience in a GMP/GxP, or a comparable federally regulated environment.
• 4+ years of supervisory or managerial experience.
• Chemistry or Biochemistry major preferred.
• Analytical laboratory experience in a GLP/GMP regulated environment is preferred.
• Experience in Systems, Applications and Products (SAP) software preferred.
• Experience in Trackwise Deviation Management software preferred.
• Sound understanding of analytical instrumentation and methodologies.  For example, 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 comp