Sr. Engineer I/II or Sr. Scientist I/II, Upstream Manufacturing Science

Company: FUJIFILM Holdings America Corporation
Location: Holly Springs
Posted on: March 11, 2023

Job Description:

Overview 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 manufacture 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 we call Genki. We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end CDMO provider in North America. The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is in Holly Springs, North Carolina, United States. The Upstream Manufacturing Science team is part of the Process Science department which provides engineering and scientific leadership to support both clinical and commercial processes in the area of cell culture operations. The Process Science team act as leads in process transfers, are Subject Matter Experts for manufacturing processes, responsible for scale up/scale down of processes as well as other projects. Cross functional collaboration throughout the entire organization is an important part of our everyday work. The department continuously strives to identify opportunities to improve systems and practices and provides direction to the manufacturing organization. As a Manufacturing Science Sr Scientist/ Sr. Engineer, you will be a part of a dedicated team with highly competent colleagues focusing on Upstream operations. You will be involved in multi-disciplinary projects working in close collaboration with team members and/or in cross functional project groups. This position provides a unique and exciting opportunity to use your breadth and depth of experience in upstream development and manufacturing to shape the future of the manufacturing science team in this $2B large scale manufacturing site. External US RESPONSIBILITIES:

• Lead process transfer subteams, including execution of laboratory experiments and guiding implementation of process parameters or controls for manufacturing processes.
• Develop project plans, timelines and communication forums to ensure a smooth tech transfer.
• Deliver documentation for internal and external use such as comprehensive written manufacturing protocols and reports, PPQ protocol/reports, summarizing investigations/impact assessments, studies and projects.
• Provide interpretation of manufacturing data, analyse laboratory- or manufacturing data to solve manufacturing problems.
• Lead and coordinate analysis of manufacturing process performance and reporting to manufacturing management
• Develop and lead training of manufacturing staff and members of the manufacturing sciences group on new processes and procedures
• Closely collaborate with our Upstream manufacturing department to support commercial/clinical programs running in the manufacturing.
• Partner with Client, Process Development, Quality, Manufacturing and Engineering on large-scale platform development, technology innovation, scale-up, and manufacturability as part of technology transfers as needed.
• Explore, asses, and recommend new equipment/platforms which improves manufacturing processes from a cost, efficiency, quality, and compliance perspective.
• As subject matter expert, support tech transfer stage gate reviews on incoming processes/changes to ensure the change is ready for introduction to Manufacturing. This includes acceptable process characterization/validation, risk assessments and mitigation and robust supporting data for the proposed changes.
• Responsible for leading execution of all aspects of process validation including ancillary process validation (both at-scale and small-scale studies), process performance qualification, and continued process verification, validation master plans, risk assessments, protocols and reports.
• Lead investigation teams and process transfer subteams, identify opportunities to improve manufacturability, reliability, yield and cost., and provide direction to product development teams.
• Lead/support supplier technical evaluations, risk assessments, and raw material evaluation and qualification, as well as new product introductions.
• Serve as subject matter expert across all unit operations in cell culture.REQUIREMENTS:
  • Master's degree or a BS/BA in a scientific or engineering field. You have at least 7+ years of experience, depending on educational background (Bachelor, Master or Ph.D.), within tech transfers in biopharmaceutical or related field with a broad background drug substance biologics manufacturing
  • Prior drug substance manufacturing experience, including process validation, process transfer, commercialization, and manufacturing support and troubleshooting
  • Strong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive environment.
  • Experience communicating and collaborating cross-functionally
  • Excellent verbal and written communication, as well as presentation skills
  • Flexible, organized and solution-oriented mindset.
  • You are outgoing, have a positive can-do attitude, are proactive and with good organizational skills.
  • Self-motivation and capability of working with a high degree of independency is something you master.
  • Capability to absorb and utilize new knowledge quickly and drive data-based decisions.
  • Able to travel, domestic and international (approximately 10-20%)FDBN works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 - 130 and Export Administration Regulations in 15 C.F.R. Part 730 - 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company's ability to secure an export authorization.FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email .To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Keywords: FUJIFILM Holdings America Corporation, Cary , Sr. Engineer I/II or Sr. Scientist I/II, Upstream Manufacturing Science, Engineering , Holly Springs, North Carolina