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.
Learn more at takedajobs.com.
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