Quality Control - Manager, Microbiology

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 Manager, Microbiology under general direction, will be required to plan, organize, direct, and evaluate the routine activities of the Quality Control staff and laboratory functions to ensure the safety and reliability of products produced in compliance with The Company Quality and various regulatory requirements. Candidates for this position must have experience in Microbiology (Product Testing, Environmental Monitoring and Utility Monitoring) in a regulated pharmaceutical setting.  This individual will have a working knowledge of additional QC functions in a regulated pharmaceutical setting. They will also be involved in method verification, and routine testing for incoming, in-process, release and stability testing on finished product, critical reagents, and raw materials as needed. The Quality Control Manager, Microbiology will also be responsible for staff hiring, supervision, coaching, discipline and performing annual review assessments.

Reports to                Associate Director, Quality Control Contamination and Control

Work Location         College Station, TX 

Travel                         As needed

Primary Responsibilities:

• Generate staff shift and schedules aligned with required QC and manufacturing support functions.
• Reviewing data and problem solving in support of microbiological analysis.
• Provide clear and understandable direction and goals to supervisors and immediate team as applicable.
• Interpret applicable quality and regulatory requirements and develop associated policies for the laboratories operations.
• Manage operating costs for the outsourced testing and laboratory supplies.
• Develop and enhance the Company EM/UM program, an author/review trend report for all FDBT facilities.
• Establish, monitor, and investigate Action and Alert limit excursions and implement corrective and preventive actions, as needed in collaboration with extended manufacturing and QA team.
• Investigate and trend invalid and out-of-specification results.
• Make critical decisions concerning analytical results (raw material, microbiology, EM/UM).
• 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.
• Interface with investigators during both internal and external inspections including regulatory audits.
• Evaluate external audit observations and develop responses and oversight for related action plans.
• Adapt, develop, or review and approve procedures, protocols and reports.
• Follow all established laboratory, regulatory, safety, and environmental procedures.
• Adhere to the standards of quality ruled by current GMP and the company Quality Policies and site SOPs.
• Identify deviations and report possible preventative and corrective actions.
• Must follow good documentation practices in all aspects and phases of the work; provide reports for review in a timely manner; work with other lab personnel on projects and participate in (OOS) Out-of-Specification and failure investigations.
• Demonstrated knowledge base in USP 61/USP 62/USP 85/ USP 71/ USP 787 / USP 788/ USP 789 for microbiological product testing.
• Familiar with qualification and classification of cleanrooms and performing risk assessments for selection of sites during validation activities.
• Oversight of water systems/compressed gas systems for qualifications and routine sampling
• Oversight of Microbial Identifications using different techniques.
• Maintain the safety and orderliness of the lab; apply knowledge of cGMPs and GLPs on daily basis.
• Perform training on laboratory methods and instrumentation.
• Will provide guidance to other groups within the QC organization in the absence of the Director or Associate Directors.
• Perform other duties as assigned.

Qualifications:

• Bachelor's degree in Biochemistry, Biology, Biotechnology, Microbiology or similar education and 9+ years' experience; OR
• Master's degree in Biochemistry, Biology, Biotechnology, Microbiology or similar education and 8+ years' experience.
• 4+ years of direct management or supervisory experience.
• GLP/GMP knowledge.
• Follow proper safety measures and policies while working in the lab.
• Develop staff to maximize contributions to team and company.
• Must have excellent organizational, written communications and oral communication skills.
• Perform training on laboratory methods and instrumentation.
• Ability to explain information appropriately based on the audience (i.e. technical concepts to a non-technical audience).
• Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
• Computer proficiency required.
• Detail oriented and accurate.
• Ability to multi-task and prioritize work assignments.
• Knowledge of MS Office (Word, Excel, Outlook, PowerPoint).
• 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 chemicals, gases, fumes, odors, dusts, and other hazardous materials.
• Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.
• Must be willing to work flexible hours (i.e. weekends and off-shift hours, as needed to support manufacturing activities).
• Ability to lift up to 15 lbs. regularly and up to 30 lbs. on occasion.

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.