Principal Scientist - Process Characterization
Company: FUJIFILM Diosynth Biotechnologies
Location: College Station
Posted on: May 12, 2022
FUJIFILM Diosynth Biotechnologies Texas is seeking a dynamic and
dedicated Principal Scientist to fulfill the leadership role of the
Process Characterization (PC) Unit as part of the Process
Development team at the College Station, Texas site. This person
will lead a growing team of talented scientists and work directly
with counterparts within the FDB global organization to deliver on
an expanding globally harmonized PC business model. The PC
laboratories will include state of the art instrumentation to
support late-stage process characterization activities for
biopharmaceutical programs for external sponsors. It is preferred
to find a candidate with exposure to upstream, downstream, and
analytical biopharmaceutical development and process
characterization. (Relocation assistance provided) External US
- Oversee the operation of the Process Characterization (PC) unit
at Texas providing line management and leadership to the PC unit
- Accountable for the technical delivery of multiple PC programs
by the application of scientific knowledge, project management and
- Strong working knowledge of upstream, downstream and analytical
- Scale Down Model (SDM) establishment (USP and DSP)
- Development of Process characterization experimental work plans
to identify CPPs in collaboration with the process design team,
prospective clients and relevant site of manufacture
- Delivery/ Review of Process characterization protocols that
enable robust execution of Process Characterization work flows
- Delivery of Process characterization reports, providing
sufficient depth of understanding to enable key process validation
decisions to be made.
- Track the performance of the PC unit through review of relevant
metrics indicating the performance of the unit in the following key
areas: safety, quality, staff engagement, equipment utilization,
right first time and profitability.
- Regularly communicate the performance of the unit. Identify and
implement efficiency savings to improve the performance of the unit
e.g. Review and implement systems to drive efficient data
- Host client meetings and form part of the Client engagement
process to win new business Required Skills & Abilities:
- Directs the work of PC scientists alongside the PC functional
leads and ensures that project milestones are met on time and to
- Providing expert scientific counsel to clients and project
teams on the most appropriate way to execute Process
characterization work plans to support process validation at the
proposal and scope development stages.
- Maintain strong communication with other technical leads from
process design, TPL group, and FDB sister site and clients.
- Representing FDB externally at meetings and conferences
including presentation Process validation approaches which enhance
the reputation of the business.
- Resolve conflicts and remove obstacles that stand in the way of
accomplishing project goals and objectives.
- Support the Business using expert knowledge during Audits.
- Ensure safe systems of work are set in place to protect
- Provide opportunities to coach and develop staff working within
- Foster a quality culture where the highest standards of quality
and data integrity are valued.
- Operate the unit in line with FDBs core values, encourage, and
support all employees within the unit to do likewise.
- Develop a continuous improvement culture within the PC unit
where team members are encouraged and supported to drive
- Through implementation of appropriate systems and development
of key measures, monitor and report on operation of PC Unit.
- Work closely with the PC Project Manager in project planning
and responses to changes in priorities.
- Excellent communication and influencing skills are required to
support clients' at the most critical stage of their drug candidate
- Must work well with multiple stakeholders across multiple sites
and be sensitive to their respective requirements and will be
expected to be a member of the TPL group.
- As a senior member of the PC unit team the candidate should be
prepared to coach / mentor and provide council and guidance to
other team members.
- Forward thinking and enterprising the candidate should help the
PC unit maintain a competitive edge by remaining open to new ways
of working to improve the efficiency of the unit including the use
of high throughput technologies and software. Working Conditions &
- The candidate will be operating in a regulated environment and
must maintain in-depth awareness of the regulatory background and
expectations, industry best practices.
- A quality culture is critical and as a senior member of the
team, the candidate should uphold the highest level of quality and
data integrity standards.Minimum Qualifications:
- A minimum MS / BS and 15+ years' experience or PhD and 12+
- At least 5+ years' of management or supervisory
- Demonstrated group leadership in analytical biopharmaceutical
development is essential, along with a strong understanding of
protein upstream and downstream development and analytics. It is
preferred that the candidate have strong customer-service,
communication and leadership skills and have experience in
client-based project management. 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 or call .
Keywords: FUJIFILM Diosynth Biotechnologies, College Station , Principal Scientist - Process Characterization, Other , College Station, Texas
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