Process Development - Senior Scientist - Downstream (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. 

  The Downstream Process Development Senior Scientist functions to lead the design, execution, and interpretation of complex laboratory experiments necessary for gene therapy, vaccine, and recombinant protein purification process development with minimal oversight. The individual will lead both customer process transfer and development projects. The individual should display strong technical knowledge and scientific understanding of protein purification, as well as having experience in process development at both small and large process scales. As both a technical and supervisory role, the individual will be expected to provide significant scientific and technical contributions, as well as mentorship and guidance, within the Process Development Group.

External US

Essential Functions: 

• Participates in decision-making processes within the project team by independently and actively engaging in scientific and technical discussions.
• Serves as a Subject Matter Expert in one or more major downstream technical categories (chromatography, filtration, viral clearance, formulation, etc.).
• Leads both Process Transfer and Process Development projects, delegating work to junior scientists, as appropriate.
• Delivers presentations in both internal and client-facing technical and project meetings.
• Designs, executes, and interprets complex lab experiments and applies advanced scientific knowledge associated with protein and viral purification development activities.
• Leads scale-up and transfer of development processes into cGMP manufacturing.
• Leads multiple projects and directs multiple project teams, ensuring (good) communication and milestone adherence.
• Represents Downstream Process Development group in a client-facing role, including direct communications with internal/external technical teams.
• Supervise and manage junior technical staff including setting objectives and development plans, performance management, career development, training, mentoring, guiding, etc.  Matrix management structure.
• Preparation and authoring of technical reports, including writing and reviewing SOPs, procedures, instructions, analytical plans, protocols, and summary reports.
• Provide input on the acquisition of capital equipment and assist in personnel hiring.
• Perform all other duties as assigned.

Required Technical Knowledge and Experience

Individual will have considerable knowledge/expertise relevant to downstream processing of protein based products expressed in mammalian, bacterial, insect and yeast cells. Knowledge/expertise should be practical and focused on lab-related activities:

• Expert understanding of liquid chromatography, direct and tangential filtration, and centrifugation.
• Demonstrated proficiency with chromatography systems such as GE Healthcare's AKTA line (AKTA Pure, Avant, Pilot, and Ready), including automated method writing and technical evaluation.
• Proven experience with developing and scale-up of viral and/or protein purification strategies.
• Advanced understanding of protein and viral biochemistry and analytical techniques
• Demonstrated experience with complex problem solving and/or prevention analysis affecting both PD and GMP activities
• Knowledge of cGMP regulations and procedures, as well as pilot scale manufacturing equipment with a focus on technical transfer into cGMP operations.
• Demonstrated experience with risk reduction, large-scale problem solving, and continuous group and/or team improvement strategies
• Experience with independent design of filtration systems and chromatography strategies
• Experience with formulation development strategies
• Excellent understanding of Drug Substance process characterization and risk mitigation
• Advanced understanding of Drug Product quality target product profiles and critical quality attributes and criteria
• Proven experience with data interpretation and presentation, statistical analysis and trending, and critical data management and recording in support of regulatory requirements.

Required Skills & Abilities:

• Excellent written and oral communication skills
• Ability to effectively direct and work closely with other members of a project group and receive and provide constructive feedback
• Ability to work and lead independently and reliably across multiple projects
• Builds credibility within the process development group by acting as a reliable source for technical consultation and performing high-quality work
• Takes initiative in finding opportunities to improve group functions and tasks, as well as continuously developing own technical skills and knowledge
• Comprehensive knowledge of Microsoft Excel, Word, and PowerPoint, and experience with Microsoft Visio.
• Consistently meets deadlines and communicates issues affecting program delivery in a timely manner
• Can solve complex problems arising during transfer and GMP activities
• Takes initiative in setting and achieving personal and professional goals
• Excellent organizational and stress-management skills
• The ability to work in team oriented environment is essential, as this person will work closely with other members of the Process Development Group and participate on multidisciplinary project teams.

Supervisory Responsibility:

Carries out supervisory responsibilities in accordance with company policies and applicable laws including interviewing, hiring, planning, assigning, directing work, training and development, disciplinary actions, performance reviews, addressing complaints and resolving problems. 

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:

• 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.

Preferred Qualifications:

• Experience in pharmaceutical or biotechnology industry.
• Hands-on downstream processing experience related to viral vector production.
• Degree in Chemistry, Biology, Life Sciences or related field.

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.