Process Development - Associate Principal Scientist - 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.

The Associate Principle Scientist independently applies scientific and/or cross-functional knowledge to achieve project goals and provide technical and scientific leadership within the department.  The individual will typically lead customer projects and as expected to complete technical assignments through the self-sufficient design, execution and interpretation of complex experiments. The individual will suggest new areas for development, presents his or her own original ideas and research findings and demonstrate a solid theoretical understanding within their own scientific discipline

External US

Essential Functions:

• Independently applies scientific and/or cross-functional knowledge to achieve project goals.
• Identifies and resolves technical project issues.
• Implements strategic departmental research and development goals or ideas.
• Ensures technical quality of work for project execution.
• Responsible for some administrative and supervisory duties for the group.
• Plans client projects in terms of timing and resources.
• Accountable for accomplishing project goals and objectives; anticipates and prioritizes workflow to achieve desired outcomes.
• Monitors project plans and resources to ensure alignment with overall research goals and objectives.
• Provide technical leadership for higher level analyses involving analytical or process experimental design.
• Design, execution and interpretation of complex laboratory experiments with broad priorities set by department head.
• Defining and implementing strategies, initiatives, and actions to improve processes and procedures to ensure compliance with internal and industry standards.
• Perform higher level analyses involving analytical or process experimental design.
• Application of advanced scientific knowledge associated with larger and more complex experiments and projects.
• Interpretation and judgment of the quality of experimental outcomes and data to effectively draw conclusions and make recommendations regarding project execution.
• Defining and implementing strategies, initiatives, and actions to improve processes and procedures to ensure compliance with internal and industry standards
• May manage multiple large programs.
• Partner across company functions and collaborate effectively with respect to identifying and addressing problems and opportunities that affect or require input from multiple units within the company.
• All other duties as may be assigned.

Required Skills, Knowledge, and Abilities:

• Ability to complete technical assignments by designing, executing and interpreting complex experiments.
• Initiate new experimental approaches and related work processes and procedures that align with company and regulatory requirements.
• As appropriate, advanced application of statistical concepts for process design.
• Application of scientific knowledge to the design, conduct, and implementation of studies and projects.
• Development and implementation of technical and/or system solutions.
• Creates plans to resolve project related issues.
• Ability to benchmark available technologies relative to other companies or industries.
• Implementation of new technologies within area.
• Contribute strong technical advice to team problem solving.
• Makes decisions on technical information generated.
• Possess a solid understanding of the research literature associated with own scientific discipline; stay informed of current trends via journals, patents and personal networks of internal and external experts.
• Consistently prepares and presents complex scientific information to internal and external groups.
• As appropriate, write, review and approve SOPs/STM's/procedures/instructions.
• As appropriate, write, review and approve of analytical plans, protocols or summary reports.
• As appropriate, write, review and approve departmental and inter-departmental reports for internal and external distribution.
• Serves as an organizational spokesperson on technical issues for a specific area of expertise.
• May support Marketing & Sales activities such as proposal/scope of work review, present on behalf of department at client visits and provide laboratory tours.
• Operates across disciplines to influence scientific decisions.
• Prepares complex proposals and presentations for senior management, including issue identification and resolution.
• A voice on complex scientific and/or technical concepts.
• Develop stature in field of expertise by participation in scientific societies and meetings, review of current scientific literature and timely publications and/or patents.
• Direct communication with clients to communicate technical items and to resolve issues.
• May have communication with regulatory agencies, industry experts and consultants.

Preferred Skills & Abilities:

• Working knowledge of viruses or large molecules, mainly in Cell and Gene Therapy field.
• Good understanding of qualification and validation of analytical methods.
• Knowledge of cGMP operations, manufacturing and regulatory requirements for pharmaceutical products especially related to Cell and Gene Therapy

Supervisory Responsibility:

May carry out supervisory responsibilities in accordance with company policies and applicable laws including (but not limited) to interviewing potential candidates, planning studies, assigning tasks, training new  and existing team members. Other duties could focus on people management including 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.
• Ability to occasionally travel to other sites, vendor locations, and/or conferences.

Minimum Qualifications:

• PhD preferably in Virology, Biology, Microbiology, Chemistry, Biochemistry or a related field and four (4) years relevant experience; OR
• Master's Degree preferably in Virology, Biology, Microbiology, Chemistry, Biochemistry or a related field and eight (8) years relevant experience; OR
• Bachelor's Degree preferably in Virology, Biology, Microbiology, Chemistry, Biochemistry or a related field and ten (10) years relevant experience.

Preferred Qualifications

• Managing Teams at Scientist and Associate levels
• Previous experience interacting with Contract Manufacturing Organization (CMO) environment and/or being a part of a CMO.
• Degree in Virology, Molecular Biology, 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 email FDBTHR@fujifilm.com or call 979-431-3528.

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