Process Development - Associate Scientist - AMT
Company: FUJIFILM Diosynth Biotechnologies
Location: College Station
Posted on: May 12, 2022
Job Description:
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 documentation practices. External US Essential
Functions:
- 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
qualifications.
- 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
within MasterControl.
- Interface with other groups to drive project success, including
Analytical Development, Project Management, Quality Control, and
Quality Assurance.
- Provide assistance and training to other scientists/analyst
within Process Development and Quality Control since QC does not
have scientists.
- Champion the success and continuous improvement of the
group.
- Performs other duties as assigned. Knowledge/Technical
ExpertiseThe ideal candidate will have knowledge and expertise
relevant to viral and protein analytics and protocol-based method
evaluations.
- Some hands on experience in the following technical fields:
HPLC/UPLC, electrophoresis, spectroscopy, plate-based assays, PCR
(including quantitative and droplet digital), viral titer
assays.
- 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
methods.
- Demonstrated ability to professionally relay analytical data
and conclusions both visually and verbally.Required Skills &
Abilities:
- Builds credibility within the group by performing high quality
work and identifying opportunities to improve workflow.
- Ability to operate efficiently and productively with minimal
supervision.
- Strong oral and written communication skills.
- Good interpersonal skills and the ability to work both
individually or as part of a team.
- Demonstrated problem solving capabilities for standard
biopharmaceutical laboratory techniques.
- Comfortable multi-tasking in a fast-paced environment with
defined deliverables and deadlines.
- Comprehensive knowledge of Microsoft Excel, Word, and
PowerPoint. Supervisory Responsibility: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
office equipment.
- 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
regularly.
- Ability to wear PPE.
- Attendance is mandatory.Minimum Qualifications:
- 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
experience; OR
- Associate's Degree preferably in Chemistry, Biology, Life
Sciences or related field, with 4 years of relevant experience.
Preferred Qualifications:
- Experience in pharmaceutical or biotechnology industry.
- Experience working in a contract manufacturing or testing
organization is preferred.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 or call .
Keywords: FUJIFILM Diosynth Biotechnologies, College Station , Process Development - Associate Scientist - AMT, Other , College Station, Texas
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