QC Cell Biology Analyst II
Location: College Station
Posted on: January 26, 2023
Summary The Cell Biology Analyst II will be responsible for
participating in the Technology Transfer of established methods
into the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality
+ Participate in training the QC Bioassay Staff at FDBT in the
established release methods.
+ Perform QC analytical testing for GMP release and stability
testing as needed.
+ Perform ELISA based methods, cell based assays and qualification
of critical reagents methodologies.
+ Execute tech transfer, qualification, and validation protocols as
+ Contribute to writing and revising Standard Operating Procedures
(SOPs) and other Good Manufacturing Practices (GMP) documentation
+ Support the establishment of a system for managing test samples,
reagents and reference standards.
+ Report excursion/out-of-specification results to QC Departmental
+ Assist in the preparation of technical proposals, amendments,
reports and memoranda.
+ Provides OOS investigational support as needed.
+ Perform other duties as assigned.
Required Skills & Abilities:
+ Proficient in ELISA based methods, cell based assays and
qualification of critical reagents methodologies.
+ Ability to analyze raw data, assess assay and system suitability
+ Perform as a SME in the designated methods transferred into FDBT
+ Ability to follow safety procedures outlined in the Chemical
+ Utilize SDS sheets to properly assess chemical hazards, spill
response procedures, and PPE requirements if indicated.
+ Excellent attention to detail.
+ Computer proficiency required.
+ Excellent written and oral communication skills.
+ Excellent 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
+ 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 15 lbs regularly and up to 30 lbs on
+ Attendance is mandatory.
+ Master's degree preferably in Biology or Biochemistry with one
(1) year of relevant laboratory experience; OR,
+ Bachelor's degree preferably in Biology or Biochemistry with two
(2) years' of relevant laboratory experience; OR
+ Associates degree preferably in Biology or Biochemistry with five
(5) years' of relevant laboratory experience
+ AND one (1) year of experience in a GLP/GxP or a comparable
federally regulated environment.
+ Familiar with monoclonal antibody testing methodology.
+ Experience in assay troubleshooting and problem solving.
+ Familiar with Quality Systems.
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
If an accommodation to the application process is needed, please
email FDBTHR@fujifilm.com or call 979-431-3528.
Requisition ID: 2021-16677
External Company Name: FUJIFILM
External Company URL: https://uscareers-fujifilm.icims.com
Street: 100 Discovery Drive
Keywords: FUJIFILM, College Station , QC Cell Biology Analyst II, Professions , College Station, Texas
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