Experience Inc. Jobs

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 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 essential functions. While performing the duties of this job, the employee is required on a regular basis 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.

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.

Job Locations US-TX-College Station

Posted Date 1 week ago (11/14/2024 12:44 PM)

Requisition ID 2024-32450

Category Quality Control

Company (Portal Searching) FUJIFILM Diosynth Biotechnologies