Process Development - Senior Scientist - Upstream (Boston)
We are growing our locations and are investing more than $40 million for a new facility in Watertown, Massachusetts. The new process development and manufacturing facility will focus on viral vectors and advanced therapies.
The new site will host experimental and analytical equipment needed for viral vector and advanced therapy process development. The contract manufacturing services for early phase clinical trials are planned to begin at the site in 2023.
The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki.
The Senior Scientist Upstream will provide technology leadership for the Upstream Process Development for a variety of technical platforms, provide technical support for associated regulatory filings, and improve processes or propose modifications to equipment to deliver improvements. The Senior Scientist will act as technical lead for the development and optimization of novel cell culture and bioreactor processes for multiple viral projects. Responsibilities include cell line selection, process development, process scale-up, and tech transfer. Requires hands-on execution of process optimization, cell culture media, along with process characterization of cell culture production processes that can be transferred to the Manufacturing group as well as external collaborators.
- Develop scalable, robust, high yielding, and economically viable cell culture processes using miniature, bench-scale, and larger disposable bioreactors in the laboratory setting for the production of viral vectors.
- Provides in plant support for cGMP manufacturing of preclinical and clinical materials.
- Set-up, operate, and troubleshoot single use stirred tank bioreactors up to 200L scale.
- Carry out upstream process research and development on a variety of microbial and cell culture derived biopharmaceuticals including MAbs, Immunoglobulins, vaccines (e.g. pDNA & viral), etc.
- Assist in achieving high yielding cGMP biopharmaceutical production through clone selection, media and feed development, seed train optimization, bioreactor process scale-up, clone stability testing and effective transfer to manufacturing.
- Lead projects to develop and optimize analytical methods for product quality assessment.
- Maintain and monitor process development equipment. Propose modifications to processes or equipment to deliver improvements.
- Support analytical evaluation, interpret data and work with other team members to integrate results into overall process development plans.
- Generate, manage and evaluate critical data and records of all upstream process development operations in support of regulatory requirements.
- Collaborate and coordinate with colleagues as necessary to facilitate in technology transfer of processes, e.g., Downstream, QA, QC, etc.
- Develop and provide technical reports, data analysis, SOP's, and investigate and complete deviations as need.
- Evaluate and implement new technologies for upstream process development.
- All other duties as required.
Required Skills & Abilities:
- Hands on experience with mammalian and/or insect cell culture, aseptic techniques.
- Proven experience in the scale up and technology transfer from pilot plant to commercial scale
- Cell culture protocol experience using HYPERStack vessels.
- Proven experience using Icellis bioreactors and Triton CF 10 cell culture vessels.
- Proven experience in adherent and suspension cell culture lines.
- Excellent organizational, interpersonal, analytical skills, and problem solving skills.
- Experience/familiarity with cell culture and cell based assays is required.
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 upstream 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.