*Must have ddPCR experience for a minimum of 3 years pharma/biotech/biotech industry (combo in a GMP/GLP environment is fine). Must be willing to work 2nd shift, Mon-Fri, 2pm - 11 pm CST.

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 QC Supervisor, Cell Biology will be responsible for coordinating the installation and qualification of new analytical equipment in support of GMP release and stability testing. The Cell Biology/Immunology Supervisor will lead tech transfer activities of qualified cell based and immunological methods from designated donor laboratories. The Supervisor will play a pivotal role in selecting qualified personnel to staff the QC Cell Biology laboratory.

Reports to QC Manager, Cell Biology

Work Location College Station, TX

Primary Responsibilities:

• Supervise and lead the QC Cell Biology/Immunology Staff, including hiring, supervision, coaching, mentoring, discipline, and performing annual review assessments.
• Coordinate QC testing for GMP release and stability testing.
• Ensure QC equipment is maintained in a qualified state.
• Prepares and executes tech transfer, qualification and validation protocols and reports as needed.
• Writes, revises, and reviews Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation.
• Establish a system for managing test samples, reagents and reference standards.
• Critical reagent / system suitability qualification and management.
• 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.
• Follow all established laboratory, regulatory, safety, and environmental procedures.
• Identify deviations and report possible preventative and corrective actions.
• Perform other duties as assigned.

Qualifications:

• Master’s degree preferably in Biology, Biochemistry, or a related scientific discipline with 3+ years’ industry experience in a GMP / GxP or a comparable federally regulated environment OR
• Bachelor’s degree preferably in Biology, Biochemistry, or a related scientific discipline with 5+ years’ industry experience in a GMP / GxP or a comparable federally regulated environment.
• 2+ years of experience in a supervisory or lead role required.
• Sound understanding and knowledge of ELISA based methods including potency and colorimetric assays.
• 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.