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Principal Scientist - Process Characterization

Company: FUJIFILM Diosynth Biotechnologies
Location: College Station
Posted on: June 17, 2022

Job Description:

FUJIFILM Diosynth Biotechnologies Texas is seeking a dynamic and dedicated Principal Scientist to fulfill the leadership role of the Process Characterization (PC) Unit as part of the Process Development team at the College Station, Texas site. This person will lead a growing team of talented scientists and work directly with counterparts within the FDB global organization to deliver on an expanding globally harmonized PC business model. The PC laboratories will include state of the art instrumentation to support late-stage process characterization activities for biopharmaceutical programs for external sponsors. It is preferred to find a candidate with exposure to upstream, downstream, and analytical biopharmaceutical development and process characterization. (Relocation assistance provided) External US Essential Functions:

  • Oversee the operation of the Process Characterization (PC) unit at Texas providing line management and leadership to the PC unit team.
  • Accountable for the technical delivery of multiple PC programs by the application of scientific knowledge, project management and leadership skills.
  • Strong working knowledge of upstream, downstream and analytical areas
  • Scale Down Model (SDM) establishment (USP and DSP)
  • Development of Process characterization experimental work plans to identify CPPs in collaboration with the process design team, prospective clients and relevant site of manufacture
  • Delivery/ Review of Process characterization protocols that enable robust execution of Process Characterization work flows
  • Delivery of Process characterization reports, providing sufficient depth of understanding to enable key process validation decisions to be made.
  • Track the performance of the PC unit through review of relevant metrics indicating the performance of the unit in the following key areas: safety, quality, staff engagement, equipment utilization, right first time and profitability.
  • Regularly communicate the performance of the unit. Identify and implement efficiency savings to improve the performance of the unit e.g. Review and implement systems to drive efficient data flows.
  • Host client meetings and form part of the Client engagement process to win new business Required Skills & Abilities:
    • Directs the work of PC scientists alongside the PC functional leads and ensures that project milestones are met on time and to budget.
    • Providing expert scientific counsel to clients and project teams on the most appropriate way to execute Process characterization work plans to support process validation at the proposal and scope development stages.
    • Maintain strong communication with other technical leads from process design, TPL group, and FDB sister site and clients.
    • Representing FDB externally at meetings and conferences including presentation Process validation approaches which enhance the reputation of the business.
    • Resolve conflicts and remove obstacles that stand in the way of accomplishing project goals and objectives.
    • Support the Business using expert knowledge during Audits.
    • Ensure safe systems of work are set in place to protect staff
    • Provide opportunities to coach and develop staff working within the group
    • Foster a quality culture where the highest standards of quality and data integrity are valued.
    • Operate the unit in line with FDBs core values, encourage, and support all employees within the unit to do likewise.
    • Develop a continuous improvement culture within the PC unit where team members are encouraged and supported to drive improvements.
    • Through implementation of appropriate systems and development of key measures, monitor and report on operation of PC Unit.
    • Work closely with the PC Project Manager in project planning and responses to changes in priorities.
    • Excellent communication and influencing skills are required to support clients' at the most critical stage of their drug candidate journey.
    • Must work well with multiple stakeholders across multiple sites and be sensitive to their respective requirements and will be expected to be a member of the TPL group.
    • As a senior member of the PC unit team the candidate should be prepared to coach / mentor and provide council and guidance to other team members.
    • Forward thinking and enterprising the candidate should help the PC unit maintain a competitive edge by remaining open to new ways of working to improve the efficiency of the unit including the use of high throughput technologies and software. Working Conditions & Physical Requirements:
      • The candidate will be operating in a regulated environment and must maintain in-depth awareness of the regulatory background and expectations, industry best practices.
      • A quality culture is critical and as a senior member of the team, the candidate should uphold the highest level of quality and data integrity standards.Minimum Qualifications:
        • A minimum MS / BS and 15+ years' experience or PhD and 12+ years' experience.
        • At least 5+ years' of management or supervisory experience.
        • Demonstrated group leadership in analytical biopharmaceutical development is essential, along with a strong understanding of protein upstream and downstream development and analytics. It is preferred that the candidate have strong customer-service, communication and leadership skills and have experience in client-based project management. We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please e-mail or call .

Keywords: FUJIFILM Diosynth Biotechnologies, College Station , Principal Scientist - Process Characterization, Education / Teaching , College Station, Texas

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