FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a Principal Process Scientist/Engineer.

Join our team of passionate engineers and scientists as we drive cutting edge biopharmaceuticals from R&D lab to commercialization. Our principal 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 Principal Engineers direct the technical activity of multiple projects and troubleshoot complex technical issues to support project success. Principal 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 one to many concurrent technical transfer or process validation of client biopharmaceutical projects
  • Wide latitude for independent judgment
  • Support capital projects by providing technical expertise
  • Responsible for new project site-fit assessments
  • Demonstrate supervisory skills with staff, outside contractors and consultants
  • Demonstrate production troubleshooting knowledge
  • Prepare and deliver presentations to external audiences
  • Identify process improvements and implement

Proficiencies

  • Deep understanding and command of biotechnology, bio-production and associated technologies including fermentation, cell culture, and purification of regulated biopharmaceuticals
  • Experience leading tech transfer or process validation of biopharmaceutical processes
  • 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 experiments and 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
  • Conceives and generates significant new ideas within specific areas of research.
  • Capable of developing a facility fit strategy for programs based on limited client data

Supervision

  • A resource to colleagues within cross functional departments.
  • Responsible for directly or indirectly supervising a group of scientists and technicians
  • Act as departmental technical lead on complex programs and influences decisions within department.
  • Effective at building teams.
  • Presents his or her own original ideas and research findings.
  • Participates in global cross-functional teams to solve problems or to develop products or strategies.

Problem Solving

  • Leads others through problem solving or complicated applications involving computer systems, instrumentation and data analysis
  • Promotes technical and/or cross functional solutions
  • Creates plans to resolve project related issues.
  • Benchmarks available technologies relative to other companies or industries.
  • Applies advanced scientific concepts to complex problems.
  • Published achievements in scientific literature or presented at conferences.
  • Consultant to management throughout the organization on specific area of expertise.
  • Leads the decision-making process.
  • Implements new technologies and approaches to solve project-related problems.
  • Possesses advanced 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 and reports
  • Writes, reviews and may approve project plans
  • 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.

BACKGROUND REQUIREMENTS:

  • BSc. degree or equivalent and 15+ years of relevant experience
  • MS and 10+ years of relevant experience or equivalent
  • PhD and 7+ years of relevant experience or equivalent
  • 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 experiments and projects.
  • Able to conceive and generates significant new ideas within specific areas of research.
  • Capable of developing a facility fit strategy for programs based on limited client data

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.

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