Vir Biotechnology is seeking an experienced CMC Team Leader to drive cross-functional CMC activities for one or more of Vir's programs from early stage development through commercial life cycle. This role will involve management of all project aspects related to CMC, including process development, analytical development, technology transfer, manufacturing, regulatory submissions, and clinical and commercial supply. This newly created position is a leadership role in a matrixed environment and will report to the Vice President of CMC Strategy & Operations.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES
- Leads cross-functional CMC project teams in developing and implementing CMC strategies and activities associated with Vir's multi-modality portfolio.
- Leads the development and coordination of CMC's goals at the asset Program Team level and closely supervises progress against these goals for operational efficiency.
- Drives the execution of high quality, integrated, cross-functional project plans that bring together all CMC activities, including integration of partner / vendor activities, and ensures alignment with the overall program strategy.
- Performs critical path analysis and supports scenario planning for CMC stratagy.
- Utilizes negotiation, facilitation, meeting management, and conflict resolution skills to improve cross-functional team performance.
- Represents the CMC functions on the Program Team; collaborates closely with other Program Team members to define and deliver the project strategy.
- When required, provide project management support including administrative functions, meeting facilitation, work planning and scheduling, communications preparation and distribution.
QUALIFICATIONS AND EXPERIENCE
- BS or MS in Biotechnology, Chemical Engineering, Biology, or Chemistry; additional/postgraduate qualifications (PhD, MBA, PMP) will be a distinct advantage.
- 20+ years of experience in the pharmaceutical industry with prior experience as a CMC team leader.
- Strong technical knowledge of CMC development, CMC Regulatory Affairs, Quality, and/or Biotech Operations
- Strong leadership, negotiation, interpersonal, communication, and meeting facilitation skills.
- Proven track record in a fast-paced, challenging and complex matrixed team environment.
- Demonstrated competency and hands-on experience with typical CMC activities. Understanding of cGMP requirements and quality management systems for the pharmaceutical or biotechnology industry environment.