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, guides and informs them through the Project stages – from Tech Transfer through to GMP manufacture and disposition.

Essential Functions:

· Provides technical oversight and leadership in the delivery of customer or internal programs, from the Tech Transfer stage through GMP manufacture.

· Leads up to two standard programs and may occasionally act as a Primary Technical support for additional programs.

· Works closely with the Program Manager to ensure program and business success by communicating progress and issues which may impact timelines.

· Reviews proposals and scopes of work (SoWs), assimilates knowledge of customer processes, and translate them into detailed technical plans.

· Ensures work is performed in alignment with the SoW, helps identify additional work needed, and ensures that additional work is captured approprietly through Change Orders or additional SoWs.

· 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.

· Co-ordinates technical activities of multi-disciplinary teams (upstream, downstream, process sciences,analytical development and method qualification) to ensure that key project activities are on track.

· Attends functional Tier meetings to report progress and/or escalate issues retated to technical aspects of the program and ensures that escalations are resolved appropriately.

· Acts as multi-diciplinary technical resources to colleagues within cross-functional departments.

· Facilitates recurring and ad hoc technical meetings to ensures that PD teams review current technical progress and align on project requirements, timelines and deliverables.

· Identifies, recommends and helps implement process enhancements and improvements.

· Participates in GMP readiness activities to 1) liase across multi-funcional groups and faciliate the generation of GMP documents such sample plans, product and process specification and batch production record (BPRs), and 2) to provide technical guidance to manufacturing and tech ops teams through GMP and HAZOP reviews.

· Provides technical support to manufacturing teams during GMP manufacturing and offers technical advice to resolve processing issues.

· Assists QA in the GMP review of executed BPRs, and to provide technical guidance in the closing of comments, events, deviations and non-conformances.

· 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.

· 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.

· Perform all other duties as assigned.

Required Technical Knowledge and Experience:

Individual will have substantial understanding of process and analytical development best practices and GMP manufacturing standards for the bioprocessing of viral vectors, vaccines, proteins, and plasmid DNA based products expressed in mammalian, bacterial and insect cells. Knowledge/expertise should be practical and focused on related activities:

· Experience in reviewing and interpreting experimental data and adapting experimental plans to suit.

· Has substantial theoretical and practical knowledge in the fields of Biochemistry, Viral and/or Protein Purification and associated analytical techniques.

· Proficient in preparing summary presentations to present progress, results, issues and recommendations to customers during Face to Face and/or teleconferences.

· Capable of authoring accurate and compliant summary reports for various stages of project work.

· Ability to build excellent customer relationships using customer management skills, attentiveness to the technical needs of the customer and a prompt response to any customer requests.

· Strong problem-solving skills and a solid understanding of the research literature associated with own scientific discipline; stay informed of current trends via journals, patents and personal networks of internal and external experts.

· Proficient in resolving technical problems by the application of scientific expertise as well as by the employment of innovative solutions.

· Ability to mentor, train, and motivate a team of scientists, including providing ongoing coaching and feedback and providing input to department head regarding performance reviews and ensuring that the goals of the group are met.

Required Skills & Abilities:

· Must possess excellent interpersonal skills to deal with both international customer program managers and multifunctional internal program teams.

· Excellent organizational, stress-management, people management, and communication skills

· Possess skills in leadership and people management, to be empathetic to the needs of individual team members, and therefore build motivated and highly productive teams.

· Strong problem-solving skills and the possession of a solid understanding of the research literature associated with own scientific discipline; stay informed of current trends via journals, patents and personal networks of internal and external experts.

· Ability to direct and work closely with other members of a project group and receive and provide constructive feedback.

· Ability to work and lead independently and reliably across multiple projects.

· Consistently finds opportunities to improve group functions and tasks, as well as continuously develops own technical skills and knowledge.

· Comprehensive knowledge of Microsoft Excel, Word, and PowerPoint, as and experience with Microsoft Visio.

· Ability to be a lead in a team-oriented environment is essential, as this person will direct the work of cross functional groups and participate in multidisciplinary project teams.

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:

· Experience prolonged standing, along with some bending, stooping, and stretching.

· Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.

· Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.

· Ability to lift 50 pounds on occasion and 25 pounds regularly.

· Ability to wear PPE.

· Attendance is mandatory.

Minimum Qualifications:

· PhD in Biological sciences or related field and 2 years relevant experience; OR

· Master’s Degree Biological sciences or related field and 6 years relevant experience; OR

· Bachelor’s Degree Biological sciences or related field and 8 years relevant experience.

Preferred Qualifications:

· Experience in pharmaceutical or biotechnology industry with cGMP experience.

· Hands-on experience in upstream and/or downstream processing and the analytics related to viral vector production.

· Experience in the operation of lab scale and manufacturing scale equipment used in the purification of viruses, vaccines and biological products.

· Degree in Biology, Microbiology, Chemistry, Biochemistry or a related field.

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 FDBTHR@fujifilm.com or call 979-431-3528.