The 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.
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 structure.
- Upstream process research and development of virus and cell cultures.
- 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 rationalization.
- 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 interpretation.
- 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 discussions.
- 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 appropriately.
- All other duties as may be assigned.
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.
- 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 teams.
- Demonstrated experience leading complex projects or programs.
- Demonstrated experience in bioprocess development and/or manufacturing, specifically on cell culture / fermentation systems.
- Cell culture, lab-scale and pilot scale bioreactor experience.
- Good interpersonal, follow-up, and excellent verbal and written communication skills.
- 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 operations.
- Proven experience in the scale-up and technology transfer from pilot plant to manufacturing with extensive mammalian cell culture experience.
- Hands on experience with cell culture techniques
Preferred Skills & Abilities:
- Working knowledge of protein purification methods.
- 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 office equipment.
- Attendance is mandatory.
- Ph.D. degree in Chemistry, Biology, Life Sciences (preferably virology), or related field, with at least 8 years' experience in pharmaceutical or biotechnology industry of which at least 5 years of management/supervisory experience OR;
- Master's degree in Chemistry, Biology, Life Sciences (preferably virology), or related field with at least 12 years' experience in pharmaceutical or biotechnology industry of which at least 5 years of management/supervisory experience.
- 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 FDBTHR@fujifilm.com or call 979-431-3528.