Process Development Associate Scientist - Analytical Method Transfer
Company: FUJIFILM Diosynth Biotechnologies
Location: College Station
Posted on: June 13, 2021
Summary: The Associate Scientist - Analytical Method Transfer
(AMT) will function collaboratively and productively in a team
devoted to ensuring the quality of effective analytical methods at
FDBT. The individual should possess experience with several
bioanalytical techniques that are used to assess viruses and
proteins as well as strong technical writing skills.
The AMT group is a protocol-driven group which will primarily
perform Tech Transfer, Qualification, and Validation of test
methods coming out of the FDB analytical groups and transition them
into our Quality Control group. The position will primarily focus
on executing analytical method protocols, summarizing data,
coordinating instrumentation needs, finalizing test methods and
ensuring a seamless transition to the QC group in a manner that
sets them up for "right first time" and prolonged execution
success. The candidate will be expected to follow cGMP
- Execute method transfers/qualifications/validations based on
regulatory guidelines and industry best practices.
- Perform assays to evaluate the accuracy, precision,
specificity, linearity, robustness, and detection/quantitation
limits of analytical methods.
- Maintain laboratory instrumentation and assist with vendor
- Develop expertise on a subset of analytical methods and
participate in method troubleshooting activities.
- Maintain awareness of project timelines and milestones and
openly communicate scheduling challenges.
- Assist in the preparation of technical documents including
protocols and reports.
- Finalize analytical test methods; route documents for approval
- Interface with other groups to drive project success, including
Analytical Development, Project Management, Quality Control, and
- Provide assistance and training to other scientists/analyst
within Process Development and Quality Control since QC does not
- Champion the success and continuous improvement of the
- Performs other duties as assigned.
The ideal candidate will have knowledge and expertise relevant
to viral and protein analytics and protocol-based method
- Some hands on experience in the following technical fields:
HPLC/UPLC, electrophoresis, spectroscopy, plate-based assays, PCR
(including quantitative and droplet digital), viral titer
- Knowledge of CFR 21 part 11 compliant software packages (such
as Empower, SoftMax Pro).
- Knowledge of cGMP regulations.
- Understanding of data analysis tools and relevant statistical
- Demonstrated ability to professionally relay analytical data
and conclusions both visually and verbally.
- Comprehensive knowledge of Microsoft Excel, Word, and
This position will not have direct reports.
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, along with some bending,
stooping, and stretching.
- Use hand-eye coordination and manual dexterity sufficient to
operate a keyboard, photocopier, telephone, calculator, and other
- Potential for exposure to hazardous chemicals, gases, fumes,
odors, mists, and dusts, and other hazardous materials.
- Ability to lift 50 pounds on occasion and 25 pounds
- Ability to wear PPE.
- Attendance is mandatory.
- Master's Degree preferably in Chemistry, Biology, Life Sciences
or related field; OR
- Bachelor's Degree preferably in Chemistry, Biology, Life
Sciences or related field, with one (1) year of relevant
- Associate's Degree preferably in Chemistry, Biology, Life
Sciences or related field, with 4 years of relevant
- Experience in pharmaceutical or biotechnology industry.
- Experience working in a contract manufacturing or testing
organization is preferred.
Keywords: FUJIFILM Diosynth Biotechnologies, College Station , Process Development Associate Scientist - Analytical Method Transfer, Other , College Station, Texas
Didn't find what you're looking for? Search again!