We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.
FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a Staff Process Scientist/Engineer. Join our team of passionate engineers and scientists as we drive cutting-edge biopharmaceuticals from R&D lab to commercialization. Our Staff Engineers are responsible for technical transfer of a wide variety client projects into our manufacturing facilities. From first clinical batch, to PPQ, to Pre-Approval Inspection – you will be there. No two days are alike and your level of ownership for projects will be high. Our Staff Engineers direct much of the technical activity of multiple projects and troubleshoot complex technical issues to support project success. Staff Engineers provide leadership to junior members and provide comprehensive technical direction throughout the organization. If you are ready to grow your career, work hard, and make a substantial impact in patients’ lives, consider joining our team.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- Responsible for many aspects of technical transfer or process validation of client projects in and to manufacturing as applicable
- Wide latitude for independent judgment
- Support capital projects by providing technical expertise
- Manage large complex engineering projects
- May be responsible for new project site-fit assessments as needed
- Apply engineering design principles
- Demonstrate production troubleshooting knowledge
- Support development of engineering and technology transfer policies
- Identify process improvements and implement
- Understanding and command of biotechnology, bio-production and associated technologies including fermentation, cell culture, and purification of regulated biopharmaceuticals
- Experience in Tech Transfer or Process Validation of biopharmaceutical processes
- Directs technical activity associated with many aspects of projects.
- Able to apply advanced computer systems, and relevant instrumentation and data analysis knowledge to complex and unusual situations
- Applies advanced scientific and engineering knowledge associated with larger and more complex projects.
- Defines and implements strategies, initiatives, and actions to improve processes and procedures to ensure compliance with internal and regulatory standards.
- Partners across company functions and collaborates effectively with respect to identifying and addressing problems and opportunities that affect or require input from multiple units within the company.
- Capable of developing a facility fit strategy for programs based on limited client data
- Work under minimal supervision on complex projects and may assist/direct less experience peers
- A resource to colleagues within the function. May indirectly supervise others within line function.
- May presents his or her own original ideas and research findings.
- Leads cross-functional teams to solve problems or to develop products.
- Develops and directs technical and/or system solutions.
- Creates plans to resolve project related issues.
- Effectively benchmarks available technologies relative to other companies or industries.
- Implementation of new technologies within area.
- Contributes strong technical advice to team problem solving.
- Makes decisions on technical information generated.
- Possesses a solid understanding of the research literature associated with own scientific discipline; stays 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.
Oral & Written Communication
- Review and approval of SOPs/procedures
- Review and approval of qualification/validation/tech transfer protocols or reports
- Writes and reviews departmental and inter-departmental reports for internal and external distribution.
- Makes presentations within department and outside of department.
- Present at project teams as department or division representative.
- May present papers or posters at scientific meetings.
- Establishes cross-functional communication across FFDB.
- Direct communication with clients to communicate technical items and to resolve issues.
- Direct communication with regulatory agencies, industry experts and consultants.
- Significant impact on department performance; drives department results; impact is achieved primarily by personal efforts or leading others.
- degree or equivalent and 10+ years of experience
- MS and 8+ years or equivalent
- PhD and 4+ years or equivalent
FDBU 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. FDBU 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.
FDBU 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.