SENIOR SCIENTIST, DRUG PRODUCT PROCESS & FORMULATIONS
San Francisco, CA /
CMC – Process Development /
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 Senior Scientist to join the newly formed Drug Product Process Development and Formulation group. The position includes developing formulations for multiple modalities in biologics as well as supporting clinical stage process development and manufacturing. This position encompasses early and late-stage drug product development cycles. The successful candidate will design and oversee formulation development for Vir molecules both internally and with contract manufacturing organizations. Responsibilities will include driving the technical aspects of manufacturing, tech transfer, and scientific oversight of drug product and process data generated internally and with partner organizations.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES:
- Develop robust, stable and effective formulations for monoclonal antibodies, viral vector(s) and/or SiRNA modalities.
- Support the development of manufacturing processes for parenteral dosage forms of biologics for the clinic and market.
- Perform lab work in-house as needed to support formulation and manufacturing process development activities.
- Support technical transfer of manufacturing process from development to clinical and commercial contract manufacturing organizations.
- Author technical reports, regulatory submissions, test methods, validation protocols/reports and white papers, as needed.
QUALIFICATIONS AND EXPERIENCE:
- Bachelor’s Degree with 12+ years’ experience, Master’s Degree with 8+ years’ experience or PhD with 5+ years in Biosciences, Pharmaceutical Technology, Biochemistry, Chemistry, Chemical Engineering or a related discipline.
- Must possess a solid understanding of pharmaceutical development, particularly as related to biological drug development; experience with other biologic modalities such as viral vaccines or gene therapy is a plus.
- Must possess experience with formulation and drug product development with monoclonal antibodies, viral vector and/or SiRNA formulations.
- Technical writing skills and experience authoring development reports, batch records, SOPs, regulatory filings, or other documents.
- Experience in design of experiment (DoE) and using statistical programs.
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.