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 Associate Director, Downstream Process Development, to lead the development of recovery and purification processes for recombinant antibodies. This individual is responsible for the development of both the early stage clinical and late stage/commercial purification processes, defining studies and over-seeing execution of stage-appropriate and robust processes for scale-up, as well appropriate process characterization and validation strategies in support of biologics license applications and market authorization applications which are primarily carried out at contract manufacturing organizations. This individual will develop processes together with a group of engineers/scientists responsible for the downstream development of Vir's product modalities - recombinant antibodies, nucleic acid therapies and viral vector products. He or she will also represent the department on cross-functional teams and develop content for relevant CMC sections of regulatory documents.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES
- Provide strategic and technical leadership in the development of purification processes used for manufacturing of Vir's recombinant antibodies
- Provide strategic and technical leadership in the characterization, validation, and tech transfer activities required to ensure successful execution of the processes at external CDMOs.
- Manages interaction with CMO facilities and vendors that support early-stage and late-stage monoclonal antibody process development and process characterization activities.
- Develop the content of relevant the CMC sections of regulatory dossiers, supporting regulatory queries and inspections. Demonstrates excellent scientific writing skills to draft/review various reports including lab study reports and process development/characterization reports.
- Model chromatography and filtration processes for deeper process understanding and establishes modeling tools to predict process performances.
- Demonstrates expertise knowledge of scale up/scale down principles with respect to chromatographic purification and filtration analysis.
- Lead a small team of engineers/scientists that develop purification processes for recombinant antibodies, nucleic acid therapies and viral vector products.
QUALIFICATIONS AND EXPERIENCE
- Preferred PhD degree in chemical engineering or scientific discipline related to protein purification with a minimum of 7+ years' related industry experience.
- Expert knowledge of monoclonal antibody purification process development and successful application of process characterization, validation and tech transfer strategies is required.
- Experience with virus/viral vector purification and siRNA purification is a plus.
- Expert knowledge of fundamentals of all modes of chromatography and filtration processes including successful demonstration of biopharmaceutical purification scale-up/scale-down principles, and a strong understanding of protein biochemistry/biophysics.
- Demonstrated expertise in purification optimization to maximize cost-efficiency and yield.
- Proven track record of leading a staff of scientists/engineers and managing multiple concurrent technical projects
- 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.
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.