Process Development - Scientist I - 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 at the site in 2023.
The Scientist I assists in the planning of, conducting, evaluating, and interpreting routine laboratory experiments. The individual monitors ongoing experiments and identifies and resolves or suggests alternates or solutions to complex occurrences. The individual understands and applies use of equipment, technology and materials associated with analytical development and related studies and projects. The individual takes a more active role in non-routine analytical or process development activities.
- Participates in the development of new analytical methods, processes or technologies
- 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 internal customers regarding problems, updates, and/or results.
- Participate in the transfer of analytical methods from other collaborators/clients.
- Maintain a laboratory notebook according to company guidelines.
- Summarize results and generate reports.
- Understands and applies required techniques in support of projects and studies according to pre-defined plans and protocols.
- Maintain analytical instrumentation as needed and interface with external vendors for instrument installation and operation qualifications.
- May train or provide guidance to lower level scientists
- May direct technical work encompassing one aspect of a project under the oversight of more senior staff.
- Stay abreast of new technologies in the field.
- Expand expertise to other types of assays.
- Ensure lab is maintained (organized, clean, properly supplied).
- As appropriate, writes SOPs/procedures/instructions
- As appropriate, may participate in assay qualification process
- As appropriate, writes and reviews analytical plans, protocols or summary reports
- As appropriate, may write SME content of technical reports (memos, development reports etc.)
- All other duties as may be assigned.
Required Skills & Abilities:
- Advanced knowledge of basic, viral vector, chemical and/or biochemical analysis and associated techniques.
- Independent use and application of more complex instrumentation, computer systems and software for data acquisition and analysis.
- Experience with analytical instrumentation such as analytical chromatography/ELISA, DLS, Nanosight or CE.
- Experience in assay development.
- Ability to work with minimal supervision.
- Able to monitor on going experiments and identify and resolves or suggests alternates or solutions to complex occurrences.
- Ability to understand basis of experimental design.
- Work professionally as part of a team and independently.
- Ability to work on multiple projects.
- Some knowledge of cGMP (current Good Manufacturing Practices).
- Some knowledge of statistics for analytical chemistry.
- Demonstrated knowledge of analytical techniques demonstrated through industry or academic performance.
- Ability to work on multiple problems of higher complexity.
- Implementation of new methods and processes.
- Adequately assembles reports and presentations describing scientific information.
- Familiarity with available new technologies and vendor offerings.
- Ability to clearly communicate in writing and verbally to senior management and/or internal clients.
- Ability to write and perform detailed analytical procedures.
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.
Minimum Qualifications (in addition to the required skills and abilities):
- Master's Degree in a science related field, with one (1) year of relevant experience; OR
- Bachelor's Degree in a science related field, with four (4) years of relevant experience; OR
- Associate's Degree in a science related field, with six (6) years of relevant experience.
- Degree in Chemistry, Biology, Life Sciences or related field.
- Experience working 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.