Process Development - Scientist II - Analytical Development (Boston)

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 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. 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.

Summary:  

The Scientist II assists in the planning of, conducting, evaluating, and interpreting routine laboratory experiments. The individual monitors on going 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. 

External US

Essential Functions:

• Advanced knowledge of basic virology viral vector, chemical and/or biochemical analysis and associated techniques.
• Leads the development of new analytical methods, processes or technologies.
• Ability to work with team members and client to troubleshoot and solve complex problems meet project needs.
• Ability to present to senior management and/or internal customers regarding problems, updates, and/or results.
• Lead transfer of analytical methods from other collaborators/clients.
• Independent use and application of more complex instrumentation, computer systems and software for data acquisition and analysis.
• 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.
• Train or provide guidance to peers.
• 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, participate in assay qualification process.
• As appropriate, writes and reviews analytical plans, protocols or summary reports.
• As appropriate, write SME content of technical reports (memos, development reports etc.).
• All other duties as may be assigned.

Required Skills & Abilities:

• Experience with analytical instrumentation such as analytical chromatography/ELISA, DLS, Nanosight or CE.
• Experience in assay development.
• Ability to work with minimal supervision.
• Strong hands-on skill in aseptic technique, cell culture, and virology.
• Able to monitor on going experiments and identify and resolves or suggests alternates or solutions to complex occurrences.
• Ability to design experiments independently.
• Work professionally as part of a team and independently.
• Ability to work on multiple projects.
• 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):

• Entry level position for a PhD degree (in virology, molecular biology or related field) with no prior experience
• Master's Degree (in virology, molecular biology or related field) , with at least 2 years of relevant experience; OR
• Bachelor's Degree (in virology, molecular biology or related field) , with at least 4 years of relevant experience

Preferred Qualifications

• 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.