Process Development - Assoc. Principal Scientist - Upstream (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, Upstream Process Development, functions independently and productively in the Upstream Process Development Group actively engaging in process development within a team-based PD laboratory to support a wide variety of vaccine development projects. The Associate Principal Scientist is responsible for managing a group of scientists and providing technical or scientific leadership with the research and development organization including ongoing coaching and feedback, performance management, and ensuring the goals of the group are met.
The individual should display technical knowledge and scientific understanding of cell cultures and viral vector production. The individual must have experience in process development for both small and large process scales for viral vector manufacturing. The individual will lead internal and client-based projects and is expected to provide scientific and technical contributions within the Process Development Group.
Individual will have broad knowledge and hands-on expertise relevant to Upstream processing of cell, virus, and recombinant protein based products expressed in mammalian, bacterial, insect and yeast cells. Knowledge/expertise will focus on the following activities:
- Supervise technical staff including setting objectives and development plans, performance management, career development, training and mentoring.
- Lead the team and/or advise team members involved in product development.
- Perform and oversee upstream process development of virus and cell cultures.
- Hands-on lab work designing and executing multipart experiments and projects based on skill set and knowledge.
- Provide support to the Director, Upstream Process Development in the management of the group and be effective and efficient in a fast-paced and dynamic environment.
- Serve as a Subject Matter Expert (SME) for the development of robust, scalable, reproducible, high performing upstream processes with emphasis on transferability to cGMP manufacturing.
- Participate in the development of PDO strategy, vision, and direction; and assist in forming decisions that establish objectives for the overall direction or operation of a significant project or area.
- Collaborate with others on the direction of activities relevant to long-term objectives.
- Support the development and implementation of processes from bench through scale-up, and to pilot scale, including technology transfer through clinical manufacturing.
- Actively manage the day-to-day activities in PDO upstream laboratories, including instrument care, maintenance, and troubleshooting and data interpretation.
- Document writing, including SOPs, manufacturing batch records, data interpretation, presentation, statistical analysis, trending and other project/process related documents.
- Be involved in decision-making processes within the project team by actively engaging in scientific and technical discussions.
- Participate in the generation of project and cost proposals, timelines, and work plans by applying scientific knowledge and project management experience.
- Work within the department and with Process Sciences to ensure successful tech transfer of projects.
- Monitor project plans and resources to ensure alignment with overall research goals and objectives.
- Train and coach new and existing team members on cell culture principles, laboratory operation, viral vector production, data collection, and relevant analytical tools.
- Provide input on the acquisition of capital equipment.
- Be in charge for project/process tech transfer to manufacturing or method qualification with Quality Control.
- Provide guidance to upstream, downstream and analytical development teams regarding new and improved approaches and technologies. Participate in global cross-functional teams to solve problems
- Ensure environmental and safety practices are implemented in the lab and pilot plant areas. Work with assigned safety officials. Participate in introducing basic Lean Production System tools to department.
- All other duties as may be assigned.
Required Skills & Abilities:
- Build credibility within PDO by performing high quality work.
- Participate in the expansion of the technical capabilities of PDO Group.
- Hands-on experience in both small and large process scale-up for mammalian, bacterial, and viral vector manufacturing including both adherent and suspension platforms
- Work in and support a team oriented environment.
- Proficient with Microsoft Office, including Word, Excel, and PowerPoint as well as other analytical applications/programs.
- Good interpersonal, follow-up, and excellent verbal and written communication skills.
- Demonstrate ability to prepare/present scientific information, progress and updates to internal and external groups.
- Work independently with minimal supervision and/or guidance.
- Maintain a good grasp of cGMP and pilot scale manufacturing equipment and practices and with the transfer of technology to cGMP operations.
- Strong problem-solving and troubleshooting skills.
- Ability to manage multiple priorities.
- Keep up with new technologies, regulatory requirements and quality standards related to area of development.
Preferred Skills & Abilities:
- Working knowledge of viruses or large molecules mainly in Cell and Gene Therapy field.
- God understanding of virology and how it relates to viral vector manufacturing.
- Perception of cGMP operations, manufacturing and regulatory requirements for pharmaceutical products especially related to Cell and Gene Therapy.
Carries 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 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 (In addition to the above skills and abilities):
- D. degree in a science related field, with at least four (4) years' relevant experience of which at least two (2) years consists of management/supervisory experience; OR
- Master's degree in a science related field, with at least eight (8) years' relevant experience of which at least two (2) years consists of management/supervisory experience; OR
- Bachelor's degree in a science related field and ten (10) years of relevant experience of which at least two (2) years consists of management/supervisory experience.
- Matrix management experience.
- 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 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.