Technical Project Leader

1 week ago

Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full time
Position Overview

The Technical Project Leader (TPL) provides technical and scientific leadership to external (client) and internal projects and is accountable for the delivery of the challenging technical elements of the program. The TPL guides customer projects through the initial kick-off and technical transfer stages, including process development and scale up, manufacturing readiness, and clinical GMP manufacturing.

The TPL directs the work of multi-disciplinary teams and ensures that project milestones are met on time and to budget, thus ensuring that program margins are achieved. The TPL also serves as the primary technical point of contact for the customer on a program, guiding and informing them through the Project stages – from Tech Transfer through to GMP manufacture and disposition.

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FUJIFILM Diosynth Biotechnologies call Genki.

Job Description

Essential Functions:

  1. Provides technical oversight and leadership in the delivery of customer or internal programs, from the Tech Transfer stage through GMP manufacture.
  2. Leads up to two standard programs and may occasionally act as a Primary Technical support for additional programs.
  3. Works closely with the Program Manager to ensure program and business success by communicating progress and issues which may impact timelines.
  4. Reviews proposals and scopes of work (SoWs), assimilates knowledge of customer processes, and translates them into detailed technical plans.
  5. Ensures work is performed in alignment with the SoW, helps identify additional work needed, and ensures that additional work is captured appropriately through Change Orders or additional SoWs.
  6. Acts as the primary technical contact for the customer, keeping them regularly informed of progress and issues, and responding promptly to the customer's technical requests.
  7. Coordinates technical activities of multi-disciplinary teams (upstream, downstream, process sciences, analytical development and method qualification) to ensure that key project activities are on track.
  8. Attends functional Tier meetings to report progress and/or escalate issues related to technical aspects of the program and ensures that escalations are resolved appropriately.
  9. Acts as multi-disciplinary technical resources to colleagues within cross-functional departments.
  10. Facilitates recurring and ad hoc technical meetings to ensure that PD teams review current technical progress and align on project requirements, timelines and deliverables.
  11. Identifies, recommends and helps implement process enhancements and improvements.
  12. Participates in GMP readiness activities to liaise across multi-functional groups and facilitate the generation of GMP documents such as sample plans, product and process specification and batch production record (BPRs), and to provide technical guidance to manufacturing and tech ops teams through GMP and HAZOP reviews.
  13. Provides technical support to manufacturing teams during GMP manufacturing and offers technical advice to resolve processing issues.
  14. Assists QA in the GMP review of executed BPRs, and to provide technical guidance in the closing of comments, events, deviations and non-conformances.
  15. Interacts with the Process Sciences group on late phase programs during the design and delivery of FMEA and PC studies, and the support of process validation activities when required.
  16. Acts as the project's technical expert to provide guidance and input to the design and delivery of FMEA, process characterization and validation studies, and to regulatory audits.
  17. Performs all other duties as assigned.
Minimum Qualifications:
  1. PhD in Biological sciences or related field and 2 years relevant experience; OR
  2. Master's Degree Biological sciences or related field and 6 years relevant experience; OR
  3. Bachelor's Degree Biological sciences or related field and 8 years relevant experience.
Preferred Qualifications:
  1. Experience in pharmaceutical or biotechnology industry with cGMP experience.
  2. Hands-on experience in upstream and/or downstream processing and the analytics related to viral vector production.
  3. Experience in the operation of lab scale and manufacturing scale equipment used in the purification of viruses, vaccines and biological products.
  4. Degree in Biology, Microbiology, Chemistry, Biochemistry or a related field.
EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBTHR@fujifilm.com or (979) 431-3500).

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