FUJIFILM

  • Director, Commercial Operations

    Job Locations US-NC-Durham
    Posted Date 2 weeks ago(10/30/2018 5:44 PM)
    Requisition ID
    2018-3274
    Category
    Manufacturing
    Company (Portal Searching)
    FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
  • Overview

    We are looking for a talented Director of Commercial Operations to help identify and address unrealized opportunities for reliability, efficiency, agility delivery of commercial operations at this CDMO. This highly visible and influential position reports directly into Sr. Director of Manufacturing, is a key member of the manufacturing leadership team and will interact closely with leaders or business performance managers of other site functions. Reporting to this role will be Process Engineers 3-5 staff dedicated to value-driving commercial projects.

     

    The successful candidate will be responsible for understanding of commercial manufacturing operations in agile environments, financial cost structures, the ability to go beyond the analysis of existing data to arrive at smooth commercial operations. Ensure execution and release of commercial batches on time.   Ensures continuous monitoring of process trends and identifies process improvements to work with clients on implementation of improvements in alignment with the client filing strategies.

     

    #CB

     

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    External US

    Responsibilities:

    • Functions as primary oversight of CDMO Commercial activities, engaging input from other counterparts as needed to inform key decisions
    • Experience in the implementation and support of biopharmaceutical manufacturing processes
    • Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
    • Experience working with commercial manufacture of biologics using single use technology
    • Experience related to upstream and/or downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP). This includes technical support for nonconformance investigations and other commercial support activities
    • Experience in working with design and optimization of pharmaceutical processing unit operations including cell expansion, harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration among others for a variety of biological molecules
    • Ability to apply engineering principles and statistical analysis, including process trending, in-order to solve processing issues and evaluate opportunities for process improvements
    • Experience in the analysis of data generated from a variety of analytical techniques
    • Strong oral and verbal communication and presentation skills
    • Basic understanding cGMP requirements
    • Review and approve post launch change controls, CAPAs and other commercial documentation
    • Provide quality advice and gather information from appropriate functions during ideation for any changes
    • Participate in inspections as needed, authors regulatory filings
    • Provides quality advice to teams and clients on regulatory strategy
    • Ensures activities are in line with budget and support evidence-based resource needs
    • Management, development, and selection of highly qualified staff

     

    Preferred Qualifications:

    • Doctorate degree and 4 years of directly related experience in biopharmaceutical manufacturing processes or
    • Master’s degree and 8 years of directly related experience in biopharmaceutical manufacturing processes or
    • Bachelor’s degree and 10 years of directly related in biopharmaceutical manufacturing processes

    AND

    • 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

    Required Qualifications:

    • Bachelor’s Degree in a Science Field
    • Leadership skills and the ability to oversee multiple projects simultaneously
    • Familiar with combination products including applicable guidance, regulations and standards e.g. ISO 14971, ICH Q9, ICH Q10, ICH Q12, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211
    • Experience providing expertise using quality engineering methodology to resolve investigations
    • Experience conducting process engineering risk assessments
    • Experience in developing sampling plans and control strategies
    • Prior experience leading and/or working as part of a combination product launch team
    • Able to successfully manage workload to timelines
    • Familiarity with basic project management tools
    • Ability to negotiate a position after taking feedback from multiple sources
    • Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results
    • Ability to operate in a matrixed or team environment with site, functional, and executive leadership
    • Experience driving decision making
    • Understanding of industry requirements
    • Understanding of the applicable manufacturing/testing processes

     

    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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