Position Overview:
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
Company Overview:
The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies call Genki.
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.
Job Description:

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.
• 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.
• 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, Gemba, and Genki.

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.

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.

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