Sr. Principal Scientist Group Leader, Upstream Process Development
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 12, 2021
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Job Description:
Overview Summary: The Sr. Principal Scientist Group Leader,
Upstream Process Development, functions independently and
productively in the Upstream Process Development Group actively
engaged in process development within a team-based PD laboratory to
support a wide variety of vaccine development projects. The Sr.
Principal Scientist Group Leader is responsible for managing a
group of scientists and providing technical or scientific
leadership with the research and development organization including
ongoing coaching and feedback, performance management, and ensuring
the goals of the group are met. The individual should display
strong technical knowledge and scientific understanding of cell and
virus cultures, expansion, harvest, medium development, clone
selection and development, and DOE studies, as well as having
experience in process development with both small and large process
scales for vaccine development. The individual will lead multiple
projects and is expected to provide significant scientific and
technical contributions within the Process Development Group and
will work closely with other Departments to develop strong working
relationships.External US Essential Functions: Individual will have
considerable knowledge/expertise relevant to Upstream processing of
cell, virus, and recombinant protein based products expressed in
mammalian, bacterial, insect and yeast cells. Knowledge/expertise
should be practical and focused on lab-related activities:*
Supervise technical staff including setting objectives and
development plans, performance management, career development,
training, mentoring, guiding, etc. Matrix management structure.*
Leads the team and/or advises team members involved in product
development.* Perform and/or oversee Upstream process research and
development of virus and cell cultures.* Hands on lab work
designing and executing complex experiments and projects using a
wide application of complex principles, theories, and concepts.*
Provide support to the Director, Upstream Process Development in
the management of the group and be effective and efficient in a
fast-paced environment.* Develops new experimental approaches and
related work processes and procedures that align with company and
regulatory requirements.* Provide expert input into developing,
optimizing, scaling-up, and validating all steps in the upstream
process development group, including cell bank production and
characterization.* Serve as a Subject Matter Expert (SME) for the
development of robust, high performing upstream processes with
emphasis on transferability to cGMP manufacturing.* Participate in
the development of PDO strategy, vision, and direction; and assist
in forming decisions that establish objectives for the overall
direction or operation of a significant project or area.*
Collaborate with others on the direction of activities relevant to
long-term objectives.* Provide significant input in the development
and implementation of processes from bench through scale-up, and to
pilot scale, including technology transfer through clinical
manufacturing.* Actively manage the day-to-day activities in PDO
upstream laboratories, including instrument care, maintenance,
troubleshooting and data interpretation.* Identifies, develops, and
implements innovative and complex projects with significant
potential value to the Company.* Document writing, including SOPs,
data interpretation, presentation, statistical analysis and
trending.* Participation in decision-making processes within the
project team by actively engaging in scientific and technical
discussions.* Assist in the generation of project and cost
proposals, timelines, and work plans by applying scientific
knowledge and project management experience.* Resolve technical
problems through scientific understanding, options assessment, and
application of innovative solutions.* Function in matrix
management-based system and handle multiple priorities quickly and
efficiently.* Monitors project plans and resources to ensure
alignment with overall research goals and objectives.* Training new
or current team members and delegating tasks appropriately.*
Provide input on the acquisition of capital equipment.*
Participates in global cross-functional teams to solve problems or
to develop products or strategies.* Responsible for and/or assists
in documentation for tech transfer to manufacturing or method
qualification with Quality Control.* All other duties as may be
assigned.Required Skills & Abilities: * Builds credibility within
PDO by performing high quality work.* Expands the technical
capabilities of PDO Group, such as technology development, use of
the literature and systems development.* Experience in both small
and large process scale-up for mammalian, bacterial, and viral
vaccine development.* The ability to work in team oriented
environment is essential, as this person will work closely with
other members of PDO Group and participate on multidisciplinary
project teams.* Demonstrated experience participating in and
conducting complex work for projects or programs.* Proficient with
Microsoft Office, including Word, Excel, and PowerPoint as well as
other analytical applications/programs.* Ability to work on broad
and highly complex development problems on the frontiers of new
knowledge.* Cell culture, lab-scale and pilot scale bioreactor
experience.* Good interpersonal, follow-up, and excellent verbal
and written communication skills.* Demonstrated ability to
prepare/present complex scientific information to internal &
external groups.* Exercises good judgment and works independently
with minimal supervision and/or guidance.* Working knowledge of
cGMP and pilot scale manufacturing equipment and practices and with
the transfer of technology to cGMP operations.* Hands on experience
with cell culture and viral vaccine development techniques.* Strong
problem-solving and troubleshooting skills.* Ability to manage
multiple priorities while being flexible and responsive to shifting
priorities.* Responsible for maintaining up-to-date knowledge of
regulatory requirements and quality standards related to area of
development.Preferred Skills & Abilities: * Working knowledge of
protein purification methods.* Strong background in cell biology
and/or virology.* Fluency with cGMP operations, manufacturing and
regulatory requirements for pharmaceutical products.Supervisory
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. 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.* Attendance is mandatory.*
Ability to occasionally travel to other sites, vendor locations,
and/or conferences.Minimum Qualifications: * PhD degree in
Chemistry, Biology, Life Sciences (preferably virology), or related
field, with at least 7 years' experience in pharmaceutical or
biotechnology industry of which at least 3 years of
management/supervisory experience OR;* Master's degree in
Chemistry, Biology, Life Sciences (preferably virology), or related
field with at least 13 years' experience in pharmaceutical or
biotechnology industry of which at least 5 years of
management/supervisory experience.Preferred Qualifications* Matrix
management experience.* Previous experience managing tech transfers
and production in a Contract Manufacturing Organization (CMO)
environment.
Keywords: FDBT - FUJIFILM Diosynth, College Station , Sr. Principal Scientist Group Leader, Upstream Process Development, Other , College Station, Texas
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