Associate Director, Upstream Process Development
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: March 18, 2023
Overview Follow Your Genki to FUJIFILM Diosynth Biotechnologies
(FDB) The work we do at FDB has never been more important-and we
are looking for talented candidates to join us. We are growing our
locations, our capabilities, and our teams, and looking for
passionate, mission-driven people like you who want to make a real
difference in people's lives. Join FDB and help create the next
vaccine, cure, or gene therapy in partnership with some of the most
innovative biopharma companies across the globe. We are proud to
cultivate a culture that will fuel your passion, energy and drive -
what FDB call Genki.Summary: The Associate Director, 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 individual should
display strong technical knowledge and scientific understanding of
cell and virus culture, 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 provide
significant scientific and technical contributions within the
Process Development Group and will work closely with the customer
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
- Upstream process research and development of virus and cell
- Hands on lab work designing and executing complex experiments
and projects using a wide application of complex principles,
theories, and concepts.
- Manage the Process Development group to be effective and
efficient in a fast-paced environment.
- 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 the technical project lead for the development of
robust high performing upstream processes with emphasis on
transferability to cGMP manufacturing.
- Technical lead for Client development projects; communicates
project status and effectively provides technical explanation and
- Provide strategy, vision, and direction; make 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.
- Leads in the development and implementation of processes from
bench through scale-up, and to pilot scale, including technology
transfer through clinical manufacturing.
- Instrument care, maintenance, troubleshooting and data
- 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
- Work collaboratively with internal staff to generate project
and cost proposals, timelines, and work plans by applying
scientific knowledge and business expertise.
- Resolve technical problems through scientific understanding,
options assessment, and application of innovative solutions.
- Responsible for taking a leadership role in the day-to-day
operations of the project, able to handle multiple priorities
quickly and efficiently including conducting and evaluating
training for new or current team members and delegating tasks
- All other duties as may be assigned.Required Skills &
- Builds credibility within lab group by performing high quality
- Expands the technical capabilities of Process Development
Group, such as technology development, use of the literature and
- Effectively communicates results of own work though scientific
meetings, presentations, discussions and documentation with some
input from supervisor.
- 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 Process
Development Group and participate on multidisciplinary project
- Demonstrated experience leading complex projects or
- Demonstrated experience in bioprocess development and/or
manufacturing, specifically on cell culture / fermentation
- Cell culture, lab-scale and pilot scale bioreactor
- Good interpersonal, follow-up, and excellent verbal and written
- Exercises superior judgment and works independently with
minimal supervision and/or guidance.
- Experience in cGMP and pilot scale manufacturing equipment and
practices and with the transfer of technology to cGMP
- Proven experience in the scale-up and technology transfer from
pilot plant to manufacturing with extensive mammalian cell culture
- Hands on experience with cell culture techniquesPreferred
Skills & Abilities: Working knowledge of protein purification
- Strong background in cell biology and/or virology.
- Fluency with cGMP operations, manufacturing and regulatory
requirements for pharmaceutical products.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
- Attendance is mandatory.Minimum Qualifications:
- Ph.D. degree in Chemistry, Biology, Life Sciences (preferably
virology), or related field, with at least 9 years' experience in
pharmaceutical or biotechnology industry of which at least 6 years
of management/supervisory experience OR;
- Master's degree in Chemistry, Biology, Life Sciences
(preferably virology), or related field with at least 11 years'
experience in pharmaceutical or biotechnology industry of which at
least 6 years of management/supervisory experience OR;
- Bachelor's degree in Chemistry, Biology, Life Sciences
(preferably virology), or related field with at least 16 years'
experience in pharmaceutical or biotechnology industry of which at
least 6 years of management/supervisory experience.Preferred
- Matrix management experience.
- Previous experience managing tech transfers and production in a
Contract Manufacturing Organization (CMO) environment 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: FDBT - FUJIFILM Diosynth, College Station , Associate Director, Upstream Process Development, Executive , College Station, Texas
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