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Principal Engineer and Group Lead

Company: FUJIFILM Holdings America Corporation
Location: Morrisville
Posted on: September 23, 2022

Job Description:

Overview FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a dynamic and dedicated leader to fulfill the role of Principal Process Scientist/Engineer and Group Lead. The Principal Process Scientist/Engineer and Group Lead is responsible for team leadership as well and leading one to many concurrent technical transfer client projects in and to manufacturing as applicable. - This individual directs the technical activity of multiple projects and troubleshoots complex technical issues to support project success. - The Principal Process Scientist/Engineer and Group Lead also provides leadership to members of process sciences team and provides comprehensive technical direction throughout the organization. External US FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a dynamic and dedicated leader to fulfill the role of Principal Process Scientist/ Engineer and Group Lead. The Principal Process Scientist/Engineer and Group Lead is responsible for team leadership as well and leading one to many concurrent technical transfer client projects in and to manufacturing as applicable. - This individual directs the technical activity of multiple projects and troubleshoots complex technical issues to support project success. - The Principal Process Scientist/Engineer and Group Lead also provides leadership to members of process sciences team and provides comprehensive technical direction throughout the organization.MAJOR ACTIVITIES AND RESPONSIBILITIES:Responsibilities

  • Fosters the success of the overall department and his/her pod
  • Provides ongoing coaching and feedback for direct reports
  • 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 projects and assist less experienced peers
  • Responsible for new project site-fit assessments as needed
  • Demonstrate supervisory skills with staff, outside contractors and consultants
  • Plan for and manage resource assignments
  • Demonstrate 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
  • Monitor, maintain, and report group Key Performance Indicators
  • Represent Manager/Director for internal and external duties when requestedProficiencies
    • 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
    • Directs technical activity associated with many aspects of a project or multiple 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 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 (PD, MTS, MFG, QA, PM and Engineering departments) and collaborates effectively with respect to identifying and addressing problems and opportunities that affect or require input from multiple units within the company.
    • Conceives and generates significant new ideas within specific areas of research.
    • Capable of developing a facility fit strategy for programs based on limited client dataSupervision
      • Responsible for directly supervising a pod team consisting of 6-7 scientists and technicians
      • Supports and drives a safety first culture
      • A resource to colleagues within cross-functional departments.
      • Act as departmental technical lead on complex programs and influences decisions within department.
      • May lead multiple client projects.
      • Effective at building teams.
      • Applies diverse scientific knowledge to assignments.
      • 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.
      • Identify and select team members as neededProblem 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.
        • Supports decision making in shaping FDB research and development agenda.
        • Leads the decision-making process.
        • Implements new technologies and approaches to solve project-related problems.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
          • Writes, reviews and approves departmental and inter-departmental reports for internal and external distribution.
          • Serves as an organizational spokesperson on technical issues for a specific area of expertise.
          • Operates across disciplines to influence scientific decisions. -
          • 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.
          • Direct communication with site and global leadership and clients to communicate technical items and to resolve issues.
          • Direct communication with regulatory agencies, industry experts, and consultants.ORGANIZATIONAL STRUCTURE:This position typically reports to the Director of Process SciencesBACKGROUND 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
            • Deep understanding and command of biotechnology, bio-production and associated technologies including fermentation, cell culture, and purification of regulated biopharmaceuticals
            • 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 dataFDBU 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. If an accommodation to the application process is needed, please e-mail .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 , Principal Engineer and Group Lead, Engineering , Morrisville, North Carolina

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