QC Lead, Chemistry - Fujifilm

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. 

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 Chemist Lead, with limited supervision, will be responsible for mentoring the team on technical aspects of performing in-process, release and stability testing using the established analytical methods. This position is a pivotal role to either a technical career path as a Chemist IV or a managerial career path as a Lead for the team, and a successful individual in this role will lead the team regardless of the career path they decide to pursue.

Reports to                QC Manager, Chemistry

Work Location         College Station, TX 

Primary Responsibilities:

• Lead QC analytical testing for GMP in-process, release and stability testing as needed.
  • PH Conductivity & qPCR.
  • HPLC, RP-HPLC, SEC, Agarose Gel Electrophoresis, UPLC, CE, IEF, Protein Purity Assay, Peptide Mapping, DNA Sequencing and/or UV/Vis Spectrometry.
  • Residual Analysis and/or Surfactant Analysis
  • Osmolality testing
  • Western Blot
• Executes technical transfer, qualification and validation protocols as needed.
• Leads evaluation of equipment for use.
• Leads IQOQ evaluation.
• Help to maintain safety and orderliness of the lab; apply knowledge of cGMPs and GLPs on a daily basis.
• Technical Writing to include:
  • Writes and revises Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation as appropriate.
  • Qualification protocols.
  • Transfer Protocols.
  • Creating manuals for processes/activities.
  • Sample plans (support & edit).
  • Lead the initiation and closure of deviations, CAPAs and Change Controls.
  • Reviewing Methods for accuracy:
• HPLC, Chromatography (Ion Exchange, SEC, RP-HPLC, Residual Analytes).
• Lead technical training for less experienced members of the team.
• Facilitate the maintenance and repair of equipment.
• Facilitate the communication between various different departments.
• Develop and support a system for managing test samples, reagents, and reference standards.
• Reviews data obtained for compliance to specifications and reports excursion/out of specifications.
• Leads OOS investigations and support as needed.
• Leads QC support for the sites Environmental Monitoring program and raw material analysis.
• Ensure lab is maintained (organized, clean, properly supplied).
• Perform other duties as assigned.

Qualifications:

• Bachelor’s degree preferably in Chemistry or Biochemistry with 4+ years of hands-on laboratory experience.
• Associate’s degree preferably in Chemistry or Biochemistry with 6+ years of hands-on laboratory experience.
• 4+ years’ industry experience in a GMP/GxP or a comparable federally regulated environment required.
• Familiar with monoclonal antibody testing methodology. Experience in assay troubleshooting and problem solving. 
• Ability to analyze raw data, assess assay and system suitability criteria, understand process from beginning to end, and explain process.
• Excellent communication skills.
• Ability to work independently or in a team.
• Perform as a SME in the designated methods transferred into FDBT.
• Previous pipetting experience.
• 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.
• Excellent attention to detail.
• Computer proficiency.
• 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.
• Ability to lift up to 30 pounds on occasion.
• Attendance is mandatory.

Join us!  FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential.  We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

We 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 email FDBTHR@fujifilm.com or call 979-431-3500.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.