Technical Project Leader

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

External US

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 jour