Summary: The Microbiology Lead will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.
- Responsible for QC microbiological aspects of cGMP compliance and testing.
- Write verification protocols and summary reports as needed for finished product and in process controls and buffers.
- Assist in performing environmental risk assessments for qualification of cleanrooms.
- Serve as SME for all of the functional streams: utility monitoring, environmental monitoring and material monitoring.
- Be in charge of scheduling and managing the training and on-boarding of new staff members and be able to troubleshoot assays when there is a problem encountered.
- Assist in the identification of microbiological root cause analysis and provide technical advice as needed.
- Perform Cost Analysis for methods and monthly metrics of assays performed.
- Lead the investigations and review of alert and action limit investigations as needed and implements corrective action as appropriate.
- Manage the investigations of microbiological data deviations and PRs.
- Develop and/or contribute toward creating and revising microbiological Standard Operating Procedures (SOPs) and other current Good Manufacturing Practices (cGMP) documentation.
- Manage the weekly laboratory schedule of activities for the staff.
- Approval of EM and product release data.
- Manage the plan generation/scheduling in MODA-EM
- Manage all equipment calibrations/PM events in Blue Mountain
- Management of inventory for the laboratory and generation of Purchase Orders for supplies
- Management of CAPAs, Change Controls and Deviations for the group
- Ensure lab is maintained (organized, clean, properly supplied)
- Perform other duties as assigned.
Required Skills & Abilities:
- Sound aseptic technique and understanding of industry best practices, techniques, equipment, and materials.
- Ability to analyze raw data, assess assay and system suitability criteria.
- 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.
- Good attention to detail and ability to utilize problem solving/trouble shooting skills.
- Good computer skills.
- Minimal supervision required.
- Demonstrated written and oral communication skills.
- Demonstrated leadership skills.
- Strong organization and analytical skills.
Working Conditions & 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 lift/pull/push 50 lbs on occasion and 15 lbs regularly.
- Ability to wear personal protective equipment including safety glasses, lab coat, and gloves.
- Attendance is mandatory.
- Master's degree preferably in Biochemistry, Chemistry, Biology or related field with five (4) years of relevant GMP experience; OR
- Bachelor's degree preferably in Biochemistry, Chemistry, Biology or related field with six (5) years of relevant GMP experience; OR
- Associate of Science preferably in Biochemistry, Chemistry, Biology or related field with seven (6) years of relevant GMP experience.
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 979-431-3528.