Process Development - Senior Scientist - Downstream
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: November 21, 2022
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
- Purification methods development of specific protein
- Representation of DS PD in a customer/client facing role
including direct communications with internal/external technical
- Development of downstream protein purification processes and
technical transfer into cGMP.
- Preparation and authoring of technical reports, including
writing and reviewing SOPs, procedures, instructions, analytical
plans, protocols, and summary reports.
- Interacting with appropriate analytical and upstream functional
areas to determine appropriate method for protein
- Technical lead on moderate to large programs.
- Participation in decision-making processes within the project
team by actively engaging in scientific and technical
- 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
- 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
- Downstream development of protein purification processes.
- Protein biochemistry (protein folding, protein degradation,
- 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
- Document writing, data interpretation, presentation,
statistical analysis and trending. Required Skills & Abilities:
- Builds credibility within lab group by performing high quality
- Experience with chromatography systems such as GE Healthcare's
- Hands on experience with chromatography based processing
methods and tangential flow filtration techniques.
- Expands the technical capabilities of Process Development
Group, such as technology development, use of the literature and
- Teaches others regarding their expertise and training other
members of Process Development Group with respect to the day-to-day
lab goals and activities.
- 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
- 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
- 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
- Potential for exposure to hazardous chemicals, gases, fumes,
odors, mists, and dusts, and other hazardous materials.
- Ability to lift 50 pounds on occasion and 25 pounds
- Ability to wear PPE.
- Attendance is mandatory.Minimum Qualifications:
- Ph.D. in a science related field with 1 year of relevant
experience including some management/supervisory/lead experience;
- Master's Degree in a science related field with 6 years' of
relevant experience including some management/supervisory/lead
- Bachelor's Degree in a science related field with eight (8)
years' of relevant experience including some
- Associates Degree in a science related field with ten (10)
years' experience including some management/supervisory/lead
- Hands-on downstream process transfer experience.
- Experience working in a cGMP facility.
- Technical Project Management experience.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 , Process Development - Senior Scientist - Downstream, Other , College Station, Texas
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