This role, which can be filled at the Associate Director or Director level, is the CMC Program Lead and single point of contact for a Technical Development Team (TDT).
* Be an enterprise thinking integrator of the program CMC activities and ensure that fit for purpose CTM is available at each stage of clinical development * Work closely with the Global Program Team (GPT) leader to meet the program needs and ensure the functions are executing with agility and rigor * Agree on TDT deliverables and ensure full alignment between Functions and the GPT * Represent the TDT team and program in Vaccine Operations (VO) and VBU governance forums and on the GPT * Establish the CMC development plan in accordance with quality and regulatory expectations.
ACCOUNTABILITIES and RESPONSIBILITIES:
* Develops and tracks the CMC development plan, which is aligned with the integrated GPT plan, and ensures all program deliverables are met on time. * Develops and signs off on a TDT contract of deliverables to the GPT. * Tracks TDT program KPIs and presents updates at the Technical Development Review, Stage Gate Review and other forums. * Maintains awareness and alignment within Vaccines Operations an all Program issues being presented at GPT and/or the Development Committee (DECO). * Applies scientific knowledge and principles to influence the direction of the program. Critically reviews technical and scientific details. Identifies novel solutions to meet critical program needs. * Assesses and communicates program risks and provides risk response strategies in a timely manner to appropriate stakeholders and Vaccine Operations management. Maintains risk register and risk mitigation plan * Works proactively with Functional Area Leads (e.g. Regulatory Affairs and Quality Assurance) ensuring agility and high performance. * Represents the VO at the GPT and other meetings including with external agencies as required. * Guides Program-related inputs to the annual budgeting / MRP processes and ensures that all program activities (internal and external) are appropriately planned and budgeted.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
* Bachelor's degree required in a scientific or technical discipline; advanced level degree (Master's Degree or PhD) in a scientific or technical discipline would be an advantage. * Minimum of 10+ years of experience working in a cross functional biologics development group. This is inclusive of experience in at least one of the following areas: Technical Operations, Analytical Development, Drug Product, QA/QC or Regulatory Affairs CMC.
* Requires strong background in a technical / scientific discipline. Must have the maturity to utilize scientific and technical knowledge to provide unique solutions for the benefit of the development program. * Must demonstrate knowledge of multiple disciplines included in the TDT structure, e.g., bioprocess engineering, analytics, formulation, validation, quality assurance and/or regulatory affairs. * Requires extensive knowledge of current Good Manufacturing Practices and other Regulatory requirements related to Vaccine development and manufacturing.
* Requires ability to develop and use knowledge and interpersonal skills to influence and guide internal and external stakeholders towards the accomplishment of program and cross-divisional goals. Must play the role of an integrator * Requires ability to identify/solve technical, budgetary, and schedule risks to the program and propose appropriate risk response strategies. * Must be an excellent communicator that can distill complex concepts with clarity of thought in a concise and factual manner. Presentations and documents should be easy to understand for people with limited background knowledge.
* 20-40% travel
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