Associate Director, Upstream Process Development
Company: FUJIFILM Diosynth Biotechnologies
Location: College Station
Posted on: November 21, 2022
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 techniques Preferred
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: FUJIFILM Diosynth Biotechnologies, College Station , Associate Director, Upstream Process Development, Executive , College Station, Texas
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