Process Development - Associate Principal Scientist-Analytical Method Transfer
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: May 9, 2022
Overview Summary:The Associate Principal Scientist - Analytical
Method Transfer (AMT) focuses on the qualification and validation
of Analytical Methods used at FUJIFILM Diosynth Biotechnologies
(FDB). The AMT group is a protocol-driven group that 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 Associate Principal Scientist
position will predominately focus on managing a group in AMT to
create analytical method protocols and summary reports, executing
protocols, reviewing data, ensuring a seamless transition to the QC
group in a manner that sets them up for "right first time" and
prolonged execution success, troubleshooting issues/spearheading
investigations and working closely with the QA group and client.
The individual will typically lead customer projects and as
expected to complete technical assignments through the
self-sufficient design, execution, and interpretation of complex
experiments. External US Essential Functions:
- Manage a group(s)
- to design and execute method
transfers/qualifications/validations based on regulatory guidelines
and industry best practices.
- that perform assays to evaluate the accuracy, precision,
specificity, linearity, robustness, and detection/quantitation
limits of analytical methods.
- Act as a technical lead for client programs and provide updates
and professional recommendations to external customers.
- Maintain a thorough understanding of project timelines and
milestones and openly communicate scheduling challenges to internal
and external stakeholders.
- Independently applies scientific and/or cross-functional
knowledge to achieve project goals.
- Identifies, resolves technical project issues; ensures
technical quality of work for project execution.
- Implements strategic departmental research and development
goals or ideas.
- Responsible for some administrative and supervisory duties for
- Plans client projects in terms of timing and resources.
- Accountable for accomplishing project goals and objectives;
anticipates and prioritizes workflow to achieve desired
- Monitors project plans and resources to ensure alignment with
overall research goals and objectives.
- Provide technical leadership for higher level analyses
involving analytical or process experimental design.
- Design, execution, and interpretation of complex laboratory
experiments with broad priorities set by department head.
- Defining and implementing strategies, initiatives, and actions
to improve processes and procedures to ensure compliance with
internal and industry standards.
- May manage multiple large programs.
- Partner across company functions and collaborate effectively
with respect to identifying and addressing problems and
opportunities that affect or require input from multiple units
within the company.
- All other duties as may be assigned.Required Skills, Knowledge,
- As appropriate, write, review and approve
SOPs/STM's/procedures/instructions, analytical plans,
protocols/summary reports, departmental and inter-departmental
reports for internal and external distribution.
- Ability to complete technical assignments by designing,
executing, and interpreting complex experiments.
- Initiate new experimental approaches and related work processes
and procedures that align with company and regulatory
- As appropriate, advanced application of statistical concepts
for process design.
- Application of scientific knowledge to the design, conduct, and
implementation of studies and projects.
- Creates plans to resolve project related issues.
- Ability to benchmark available technologies relative to other
companies or industries.
- Contribute strong technical advice to team problem
- Consistently prepares and presents complex scientific
information to internal and external groups.
- Serves as an organizational spokesperson on technical issues
for a specific area of expertise.
- May support Marketing & Sales activities such as proposal/scope
of work review, present on behalf of department at client visits
and provide laboratory tours.
- Operates across disciplines to influence scientific
- Prepares complex proposals and presentations for senior
management, including issue identification and resolution.
- Develop stature in field of expertise by participation in
scientific societies and meetings, review of current scientific
literature and timely publications and/or patents.
- Direct communication with clients to communicate technical
items and to resolve issues.
- May have communication with regulatory agencies, industry
experts and consultants.Preferred Skills & Abilities:
- Hands on experience in several of the following technical
fields: HPLC/UPLC, electrophoresis, spectroscopy, plate-based
assays, PCR (including quantitative and droplet digital), viral
- Experience with CFR 21-part 11 compliant software packages
(such as Empower, SoftMax Pro).
- Experience working with a team of scientists in a direct or
- Experience working in or interfacing with a regulated cGMP
- Understanding of data analysis tools and relevant statistical
- Good understanding of qualification and validation of
- Knowledge of cGMP operations, manufacturing and regulatory
requirements for pharmaceutical products especially related to Cell
and Gene TherapySupervisory Responsibility:May carry out
supervisory responsibilities in accordance with company policies
and applicable laws including (but not limited) to interviewing
potential candidates, planning studies, assigning tasks, training
new and existing team members. Other duties could focus on people
management including performance reviews, addressing complaints,
and resolving problems. - 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.
- Ability to occasionally travel to other sites, vendor
locations, and/or conferences. -Minimum Qualifications:
- PhD preferably in Virology, Biology, Microbiology, Chemistry,
Biochemistry, or a related field and four (4) years relevant
- Master's Degree preferably in Virology, Biology, Microbiology,
Chemistry, Biochemistry or a related field and eight (8) years
relevant experience; OR
- Bachelor's Degree preferably in Virology, Biology,
Microbiology, Chemistry, Biochemistry or a related field and ten
(10) years relevant experience.Preferred Qualifications
- Managing Teams at Scientist and Associate levels.
- Previous experience interacting with Contract Manufacturing
Organization (CMO) environment and/or being a part of a CMO.
- Degree in Virology, Molecular Biology, Biology, Life Sciences,
or related field.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 e-mail FDBTHR@fujifilm.com or
Keywords: FDBT - FUJIFILM Diosynth, College Station , Process Development - Associate Principal Scientist-Analytical Method Transfer, Other , College Station, Texas
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