Director, CMC Product Strategy Team Lead – Vir Biotechnology
Product Manager
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Vir Biotechnology (201-500 Employees, 92% 2 Yr Employee Growth Rate)
36% 1-Year Employee Growth Rate | 92% 2-Year Employee Growth Rate | LinkedIn | $793.6 Venture Funding
What Is Employee Growth Rate & Why Is It Important?
Vir Biotechnology is a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.
We believe the success of our colleagues drives the success of our Mission. We have an ongoing commitment to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give at their best, we will collectively deliver outstanding results.
Vir Biotechnology is seeking a Product Strategy Leader who will be accountable for CMC product strategy to enable advancement of Vir development products. Specific responsibilities include leading or managing the CMC Team, representing CMC at Vir Program Team meetings, and serving as a primary contact for external strategic alliance partnerships in support of CMC product lifecycle management. Duties also include ensuring all regulatory milestones are met, as well as maintaining adequate clinical and/or commercial supply levels. This role will involve integration of all project aspects related to CMC, including process development, analytical development, technology transfer, manufacturing, and product release. This position is a leadership role in a matrixed environment.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES
- Leads cross-functional CMC team in developing and implementing CMC strategies and activities associated with Vir’s multi-modality portfolio.
- Ensures CMC teams deliver data and supply to enable FIH, Pivotal and Phase 4 Clinical studies
- Facilitates delivery of CMC sections of regulatory filings and ensures any RTQs are addressed in time to meet Program milestones.
- Leads the development and coordination of CMC’s goals at the asset Program Team level and integrates, cross-functional project plans that bring together all CMC activities, including integration of strategic alliance partner activities, and ensures alignment with the overall program strategy.
- Performs critical path analysis and supports scenario planning for CMC strategy.
- Represents the CMC functions on the Program Team; collaborates closely with other Program Team members to define and deliver the Vir project strategy.
QUALIFICATIONS AND EXPERIENCE
- BS/MS/MBA in Biotechnology, Chemical Engineering, Biology, or Chemistry; and 13-15+ year of experience or postgraduate qualifications (PhD) and 10+ years of experience will be a distinct advantage.
- Prior experience leading cross functional teams
- Strong knowledge of commercialization including Process and Product development, CMC Regulatory Affairs, Quality, Supply Chain 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.
This role may be performed remotely if VIR can support remote work arrangements in the state where you currently reside. This includes most states within the US. If you move forward in the hiring process, VIR recruiters will discuss options with you.
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Vir’s compensation and benefits are aligned with the current market and commensurate with the person’s experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity as well as many other Vir benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all lab essential personnel!
Vir is an equal opportunity employer. We value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact Human Resources to request accommodation.
Vir Human Resources leads recruitment and employment for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.
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