Process Development - Assoc. Principal 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 at the site in 2023.
The Associate Principal Scientist - Downstream Process Development, functions in a supervisory role in the Downstream Process Development Group actively engaged and engaging others in process development within a team based PD laboratory. The individual will typically lead customer projects and is 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.
- Independently applies extensive scientific and/or cross-functional knowledge to achieve project goals.
- Lead the development of downstream protein purification processes and technical transfer into cGMP.
- Act as a Technical Lead on multiple client projects leading the experimental design, execution and communication of all the aspects for which they are responsible.
- Initiate new experimental approaches and related work processes and procedures that align with company and regulatory requirements.
- 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.
- Originates development ideas and independently applies scientific knowledge to achieve project goals.
- Ensures the quality of work during project execution.
- Supervise technical staff including setting objectives and development plans, performance management, career development, training, mentoring, guiding, etc. Matrix management structure.
- Provide technical/scientific leadership within the department.
- Perform all other duties as assigned.
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.
Individual will have extensive knowledge/expertise relevant to downstream processing of products expressed in mammalian, bacterial, insect and yeast cells. Knowledge/expertise should be practical and theoretical, and focused on:
- Ability to develop Downstream processes.
- Extensive theoretical and practical experience with chromatography based processing methods and tangential flow filtration techniques.
- Extensive experience with a variety of downstream processing equipment and techniques.
- Deep knowledge of Protein biochemistry (protein folding, protein degradation, aggregation, etc.).
- Knowledge of the general analytical methods applicable for Biologics (HPLC, electrophoresis, PCR etc.).
- Thorough knowledge and understanding of cGMP concepts.
- As appropriate, be able to apply advanced statistical concepts for process design
- Lead troubleshooting and resolve technical issues in downstream technology transfer into cGMP manufacturing.
- Troubleshooting and data interpretation of complex issues.
- Document writing, data interpretation, presentation, statistical analysis and trending.
Required Skills & Abilities:
- Takes a lead in the technical capabilities of Process Development Group.
- Strong problem solving skills and the possession of 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.
- Oversee the delivery of transfer projects by junior scientists.
- Technical lead on a large client project or multiple smaller projects and influence decisions within the department.
- Leads cross-functional teams to solve problems or to develop products.
- Consistently prepares and presents complex scientific information to internal and external groups.
- Ability to supervise, train and motivate direct reports.
- Acts without supervision on day-to-day activities and accomplished tasks.
- Leadership input focused on status and future of project or technical area and long-term development path.
- Responsible for leading a team of Scientists, including creating project goals and development plans, teaching team members, including providing ongoing coaching and feedback and providing input to the supervisor regarding performance reviews and ensuring that the goals of the group are met.
- The ability to act as a lead in team oriented environment is essential, as this person will work closely with cross functional groups and participate on multidisciplinary project teams.
- Comprehensive knowledge of Microsoft Excel, Word, and PowerPoint.
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/pull/push 30 lbs on occasion and 15 lbs regularly.
- Ability to wear personal protective equipment including safety glasses, lab coat, and gloves.
- Attendance is mandatory.
- PhD preferably in Biology, Microbiology, Chemistry, Biochemistry or a related field and six (6) years relevant experience; OR
- Master's Degree preferably in Biology, Microbiology, Chemistry, Biochemistry or a related field and ten (10) years relevant experience; OR
- Bachelor's Degree preferably in Biology, Microbiology, Chemistry, Biochemistry or a related field and fourteen (14) years relevant experience.
- At least 2 years' experience in a lead or supervisory role.
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.