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 (Vir) is seeking an experienced scientist or engineer to lead the Manufacturing Science and Technology (MSAT) department. At Vir, the MSAT leader is accountable for providing science and technology leadership to late stage and commercial products to ensure continuity of supply, compliance with global GMP standards and competitive costs. This individual will support commercialization of our diverse development portfolio by providing scale-up, validation and regulatory submission advice. This individual will partner with process development scientists and engineers from pilot scale through commercial scale and is accountable for tech transfers and successful implementation of production process at manufacturing scale. In addition, he or she will ensure ongoing process monitoring and lifecycle management with accountability for success of pivotal manufacturing, stage 2 (PPQ) and 3 (CPV) process validation. The scope of the role includes all drug substance, drug product, device and packaging technologies used in the manufacture and supply of the commercial portfolio.
- Manage the technology lifecycle for the commercial product portfolio from approval to ongoing lifecycle management
- Support commercializing of the multi modal development portfolio by providing scale-up, validation and regulatory submission support for CMC elements of assets
- Ensure supply by establishing manufacturing capabilities at external sites through technology transfer and regulatory approval
- Represent commercial requirements to PD, Quality and manufacturing so that manufacturing and control strategies are aligned
- Partner with PD on scale-up considerations, equipment evaluation from pilot scale to commercial scale
- Provide manufacturing technology support drive a continuous improvement agenda to decrease costs, increase productivity and meet quality and compliance goals
- Develop and maintain a technology portfolio so that commercial products are compliant with global regulatory requirements
- Influence emerging regulation and modification of current regulation to ensure supply continuity, compliance and effective utilization of technology advances
- Provide leadership and development of staff as well as talent acquisition to meet current and future needs of the business.
- Provide strategic technology advice and consultation to leadership in the areas of process and analytical technology to ensure effective decision-making
- Represent the commercial product to global regulators to ensure timely approval for new product applications and lifecycle changes as well GMP inspection readiness
QUALIFICATIONS AND EXPERIENCE
- BS/MS in Biology, Microbiology, Chemistry, Engineering with advanced technical degree, MBA, and/or equivalent experiences desirable
- 18+ years of manufacturing technology experience in a complex global environment with a track record of establishing productive relationships internally and externally
- Biopharmaceutical industry experience necessary, experience with viral vectors, nucleic acid or synthetic therapeutics would be a plus
- Leadership experience in one or more CMC functions (e.g. PD, Manufacturing, Quality, Supply Chain, and Manufacturing Technology)
- Understanding of regulatory environment and challenges including experience interfacing on government/ policy issues
- Leadership experience in different manufacturing environments and in similar matrix, multi-location environments
- Brings international and intercultural experiences, and has forged strong connections with internal and external business partners
- Experience in being the lead change agent in complex transformational activities
- Demonstrated ability to hire top talent, developing others and building a successful organization
- Strong written and verbal communication skills, and familiarity with representation on inter-disciplinary and cross-functional teams.
- Ability to travel on an as-needed basis
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, one Friday a month 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.