Staff Process Scientist/Engineer

FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a Staff Process Scientist/Engineer. The successful candidate manages technical transfer of client projects in and to manufacturing. This person is the technical lead in the department and partners across company functions to identify and address issues and opportunities during the tech transfer process and throughout the client project cycle.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

 

Responsibilities

 

  • Responsible for one to many concurrent 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
  • Demonstrate supervisory skills with outside contractors and consultants
  • Apply engineering design principles
  • Demonstrate production troubleshooting knowledge
  • Support development of engineering and technology transfer policies
  • Prepare and deliver presentations to external audiences
  • Identify process improvements and implement

Proficiencies

  • 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  

Supervision

  • 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.
  • Act as departmental technical lead on one large program and influences decisions within department.
  • May manage multiple programs.
  • Presents his or her own original ideas and research findings.
  • Leads cross-functional teams to solve problems or to develop products.  

Problem Solving

  •  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, reviews and may approve project plans
  • Writes, reviews and approves 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.
  • 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.
  • Responsible for maintaining project timelines

BACKGROUND REQUIREMENTS:

  • BSc. degree or equivalent and 10+ years of relevant experience
  • MS and 8+ years of relevant experience or equivalent
  • PhD and 4+ years of relevant experience or equivalent
  • Able to apply advanced computer systems, and relevant instrumentation and data analysis knowledge to complex and unusual situations
  • Able to define and implement strategies, initiatives, and actions to improve processes and procedures to ensure compliance with internal and regulatory standards.
  • Possesses an 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.
  • 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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