Process Development - Associate Principal Scientist - Downstream
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: June 19, 2022
Overview Summary: - The Downstream Process Development Associate
Principal Scientist functions in a supervisory role in the
Downstream Process Development Group, actively engaged and engaging
others in process development within a team based PD laboratory.
The individual will independently lead customer projects and is
expected to complete technical assignments through the
self-sufficient design, execution and interpretation of complex
experiments. The individual will be expected to significantly
contribute to the technical growth and mentorship of the Downstream
Process Development group, suggest new areas for development,
present his or her own original ideas and research findings, and
demonstrate a solid theoretical understanding within their own
scientific discipline. - External US Essential Functions: -
- Serves as a Technical Lead on multiple client projects, leading
the experimental design, execution and communication of all the
aspects for which they are responsible.
- Directs and leads the work of scientists and teams across
- Independently makes decisions affecting downstream transfer and
- Serves as a Subject Matter Expert in several downstream
- Leads both Process Transfer and Process Development projects,
delegating work to junior scientists, as appropriate.
- Delivers technical presentations in client-facing meetings, as
well as presents data on behalf of FDBT during conferences,
- Independently applies extensive scientific and/or
cross-functional knowledge to design and direct plans for
development and transfer activities
- Represents Downstream Process Development group as a technical
SME during customer meetings
- Supervises junior and senior technical staff, including setting
objectives and development plans, performance management, career
development, training, mentoring, guiding, etc. - Matrix management
- Provides technical/scientific leadership within the department,
and takes a lead in the improving the technical capabilities of
Process Development Group.
- Provides input on the acquisition of capital equipment and
assist in personnel hiring.
- Initiates new experimental approaches and related work
processes and procedures that align with company and regulatory
- Perform all other duties as assignedSupervisory
Responsibility:Carries out supervisory responsibilities in
accordance with company policies and applicable laws including
interviewing, hiring, planning, assigning, directing work, training
and development, disciplinary actions, performance reviews,
addressing complaints and resolving problems. -Required Technical
Knowledge and ExperienceIndividual will have extensive
knowledge/expertise relevant to downstream processing of products
expressed in mammalian, bacterial, insect and yeast cells.
Knowledge/experience should focus on the following:
- -Considerable experience with individual and/or group
management, as well as originating and implementing individual or
team improvement strategies
- Extensive theoretical and practical experience with
chromatography based processing methods and tangential flow
filtration techniques, including design and execution.
- Substantial experience with developing - viral and/or protein
- Expert understanding of protein and viral biochemistry
(aggregation, degradation, protein folding, etc.).
- Thorough knowledge of protein and viral analytical techniques
(HPLC, ELISA, PCR, SDS-PAGE, etc.)
- Proven experience with complex problem solving and prevention
analysis, risk mitigation, -affecting both PD and GMP
- Thorough understanding of cGMP regulations and procedures, as
well as pilot scale manufacturing equipment with a focus on
technical transfer into cGMP operations.
- Experience with formulation development strategies.
- Demonstrated experience with Drug Substance process
characterization and risk mitigation
- Advanced understanding of Drug Product quality target product
profiles and critical quality attributes and criteria
- Proven experience with data interpretation and presentation,
statistical analysis and trending, and critical data management and
recording in support of regulatory requirements.
- Extensive experience with a variety of downstream processing
equipment and techniques. -Required Skills & Abilities:
- Excellent organizational, stress-management, people management,
and communication skills
- Ability to direct and work closely with other members of a
project group and receive and provide constructive feedback
- Ability to work and lead independently and reliably across
- Builds credibility with the process development group by acting
as a routine source for technical consultation
- Consistently finds opportunities to improve group functions and
tasks, as well as continuously develops own technical skills and
- Strong problem solving skills and the possession of a solid
understanding of the research literature associated with own
scientific discipline; stay informed of current trends via
journals, patents and personal networks of internal and external
- Comprehensive knowledge of Microsoft Excel, Word, and
PowerPoint, as and experience with Microsoft Visio.
- The ability to act as a lead in team oriented environment is
essential, as this person will work closely with cross functional
groups and participate on multidisciplinary project teams.
- Ability to mentor, train, and motivate a team of scientists,
including providing ongoing coaching and feedback and providing
input to department head regarding performance reviews and ensuring
that the goals of the group are met.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.Minimum Qualifications (in addition to
required skills & abilities):
- PhD in a science related field and 4 years relevant experience;
- Master's Degree in a science related and 8 years relevant
- Bachelor's Degree in a science related and 10 years relevant
- At least 2 years' experience in a lead or supervisory role.
- Experience in pharmaceutical or biotechnology industry with
- Hands-on downstream processing experience related to viral
- Degree in Biology, Microbiology, Chemistry, Biochemistry or a
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 email FDBTHR@fujifilm.com or
call 979-431-3528. -
Keywords: FDBT - FUJIFILM Diosynth, College Station , Process Development - Associate Principal Scientist - Downstream, Other , College Station, Texas
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