Senior Scientist - Downstream Process Development
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 13, 2021
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Job Description:
Overview Summary: The Senior Scientist - Downstream Process
Development, functions independently and productively in the
Downstream Process Development Group actively engaged in process
development within a team based PD laboratory. The individual
should display strong technical knowledge and scientific
understanding of protein purification as well as having experience
in process development at both small and large process scales. The
individual will provide significant scientific and technical
contributions within the Process Development Group.External US
Essential Functions: * Purification methods development of specific
protein molecule(s).* Development of downstream protein
purification processes and technical transfer into cGMP.*
Preparation and authoring of technical reports, including writing
and reviewing SOPs, STMs, procedures, instructions, analytical
plans, protocols, and summary reports.* Interacting with
appropriate analytical and upstream functional areas to determine
appropriate method for protein purification.* Participation in
decision-making processes within the project team by actively
engaging in scientific and technical discussions.* Originates
development ideas and independently applies scientific knowledge to
achieve project goals.* Provide monthly project reports to
department head summarizing milestones, successes, and issues.*
Designs, executes, and interprets complex lab experiments and
applies advanced scientific knowledge associated with larger and
more complex experiments and projects.* Supervise technical staff
including setting objectives and development plans, performance
management, career development, training, mentoring, guiding, etc.
Matrix management structure.* Perform all other duties as
assigned.Knowledge/Technical ExpertiseIndividual will have
considerable knowledge/expertise relevant to downstream processing
of protein based products expressed in mammalian, bacterial, insect
and yeast cells. Knowledge/expertise should be practical and
focused on lab-related activities:* Downstream development of
protein purification processes.* Hands on experience with
chromatography based processing methods and tangential flow
filtration techniques.* Experience with GE Healthcare's AKTA line
of chromatography systems is desired.* Protein biochemistry
(protein folding, protein degradation, aggregation, etc.).* General
analytical methods applicable for proteins (HPLC, electrophoresis,
assay development, etc.).* Knowledge of cGMP concepts.* Application
of statistical concepts and performs higher level analysis
involving analytical or process experimental design.* Troubleshoot
and resolve technical issues in Downstream technology transfer into
cGMP manufacturing.* Instrument care, maintenance, troubleshooting
and data interpretation.* Document writing, data interpretation,
presentation, statistical analysis and trending.Required Skills &
Abilities:* Builds credibility within lab group by performing high
quality work.* Expands the technical capabilities of Process
Development Group, such as technology development, use of the
literature and systems development.* Teaches others regarding their
expertise and training other members of Process Development Group
with respect to the day-to-day lab goals and activities.* May be
assigned as a technical lead on smaller to moderate programs.*
Effectively communicates results of own work though scientific
meetings, presentations, discussions and documentation with some
input from supervisor.* Minimum supervision required on day-to-day
activities and accomplished tasks.* Leadership input focused on
status and future of project or technical area and long-term
development path.* May be responsible for leading a team, including
creating project goals and development plans, teaching team
members, including providing ongoing coaching and feedback and
providing input to the supervisor regarding performance reviews and
ensuring that the goals of the group are met.* The ability to work
in team oriented environment is essential, as this person will work
closely with other members of the Process Development Group and
participate on multidisciplinary project teams.* Comprehensive
knowledge of Microsoft Excel, Word, and PowerPoint.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.Minimum Qualifications:* Ph.D. preferably in Chemistry,
Biology, Life Sciences or related field, with 1 year of relevant
experience including management/supervisory experience; OR*
Master's Degree preferably in Chemistry, Biology, Life Sciences or
related field, with 6 years' of relevant experience including
management/supervisory experience; OR* Bachelor's Degree preferably
in Chemistry, Biology, Life Sciences or related field, with eight
(8) years' of relevant experience including management/supervisory
experience.* Associates Degree preferably in Chemistry, Biology,
Life Sciences or related field, with ten (10) years' experience
including management/supervisory experience.Preferred
Qualifications:* Experience in pharmaceutical or biotechnology
industry.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 FDBTHR@fujifilm.com or call
979-431-3528.
Keywords: FDBT - FUJIFILM Diosynth, College Station , Senior Scientist - Downstream Process Development, Other , College Station, Texas
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