Process Development - Senior Scientist - Analytical Development (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 fall 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.
Summary: The Senior Scientist, under minimal supervision, will develop new methods to support clients and adapt client-specific methods to FDBT instrumentation as well as helping to qualify and/or validate them. This role will be expected to perform as the subject matter expert (SME) and provide technical leadership to the team in most aspects of the laboratory.
- Organize and oversee project timelines to meet milestones on multiple projects.
- Work with internal department groups to track timelines and provide timely updates to the client groups.
- Review client proposals.
- Lead technical work in BSL-2 and BSL-1 environments.
- Lead the development and implementation of bioanalytical assays e.g. qPCR, HPLC, ELISA, & bioassays.
- Lead interactions with external clients to understand their needs and effectively communicate these needs to internal departments. Ability to work with team members and client to troubleshoot and solve complex problems to keep the client satisfied and happy with end results.
- Clearly articulate in presentations to senior management and/or clients regarding problems, updates, and/or results.
- Lead the transfer of analytical methods from other collaborators/clients.
- Optimize assays as needed for implementation in a QC environment and train QC analysts in method performance.
- Write SOP/method qualification and validation protocols and reports, and review team contributions for accuracy.
- Maintain a laboratory notebook according to company guidelines.
- Summarize results and generate reports.
- Maintain analytical instrumentation as needed and interface with external vendors for instrument installation and operation qualifications.
- Perform as the SME and lead technical training to peers as needed.
- Stay abreast of new technologies in the field.
- Expand expertise to other types of assays.
- Ensure lab is maintained (organized, clean, properly supplied).
- All other duties as may be assigned.
Required Skills & Abilities:
- Ability to provide technical mentorship of more junior members of the group and train on assay development.
- Proficient with analytical instrumentation such as analytical chromatography/ELISA/qPCR.
- Proficient in assay development.
- Ability to work professionally as part of a team as well as independently.
- Experience with assay qualification and validation.
- Proficient in performing multiple protein assays such as ELISA, SDS-PAGE, Western blotting, HPLC, CE, cell-based assays, immunoassays and/or molecular assays such as q-PCR.
- Ability to work on multiple projects.
- Experience working in a GMP environment is required.
- Knowledge of statistics for analytical chemistry.
- Ability to formally present problems, updates, and/or results.
- Significant knowledge of bioanalytical techniques demonstrated through industry or academic performance.
- Ability to clearly communicate in writing and verbally to senior management and/or clients.
- Ability to write and perform detailed analytical procedures.
- Ability to train technical aspects of the job to analytical personnel.
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 sitting, standing, some bending, stooping and stretching.
- Ability to sit for long periods to work on a computer.
- Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
- Use hand-eye coordination and manual dexterity sufficient to operate a manual pipet and other analytical equipment is required.
- Ability to wear personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required in most areas associated with this position.
- May be required to lift up to 25 pounds frequently and up to 50 pounds on occasion.
- Attendance is mandatory.
- Ph.D. in Chemistry, Biochemistry, Biotechnology, Food Science, Biological or Chemical Engineering or a related field with 4 years of demonstrated relevant experience with at least 2 years in a GMP environment; OR
- M.S. in Chemistry, Biochemistry, Biotechnology, Food Science, Biological or Chemical Engineering or a related field with 8 years of demonstrated relevant experience with at least 2 years in a GMP environment.
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.