Process Development - Senior Scientist - Downstream
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.
- Purification methods development of specific protein molecule(s).
- Representation of DS PD in a customer/client facing role including direct communications with internal/external technical teams.
- 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 purification.
- Technical lead on moderate to large programs.
- 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.
Individual 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.
- 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.
- Experience with chromatography systems such as GE Healthcare's AKTA line.
- 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 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.
- 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.
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.
- 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 regularly.
- Ability to wear PPE.
- Attendance is mandatory.
- Ph.D. in a science related field with 1 year of relevant experience including some management/supervisory/lead experience; OR
- Master's Degree in a science related field with 6 years' of relevant experience including some management/supervisory/lead experience; OR
- Bachelor's Degree in a science related field with eight (8) years' of relevant experience including some management/supervisory/lead experience.
- Associates Degree in a science related field with ten (10) years' experience including some management/supervisory/lead experience.
- 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 e-mail FDBTHR@fujifilm.com or call 979-431-3500.