Quality Control - Cell Biology Analyst II
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: March 17, 2023
Job Description:
Overview
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB) -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.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
Control Laboratory. -
External US
Essential Functions:
- 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 needed.
- Contribute to writing and revising Standard Operating
Procedures (SOPs) and other Good Manufacturing Practices (GMP)
documentation as appropriate.
- Support the establishment of a system for managing test
samples, reagents and reference standards.
- Report excursion/out-of-specification results to QC
Departmental management.
- 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 criteria.
- Perform as a SME in the designated methods transferred into
FDBT from FDBU.
- 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.
- 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
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 15 lbs regularly and up to 30 lbs on
occasion.
- Attendance is mandatory. -Minimum Qualifications:
- 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. -Preferred Qualifications:
- 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 local law. -If an accommodation to
the application process is needed, please email FDBTHR@fujifilm.com
or call 979-431-3528. -#LI-SB2
Keywords: FDBT - FUJIFILM Diosynth, College Station , Quality Control - Cell Biology Analyst II, Professions , College Station, Texas
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