Job Type Full-time
Industry Life Science
Vir Biotechnology is seeking a highly motivated Scientist II, Oligonucleotide Process Development professional for our CMC team. The Process Development team is responsible for the development of drug substance processing methodologies across all modalities that can be easily transferred to the cGMP Manufacturing Team and CMO. The primary focus of this role is to develop robust and scalable late phase manufacturing processes and to support the technology transfer, process characterization and process validation for Vir’s siRNA modality.
Responsibilities and learning opportunities:
- Manages siRNA late phase process development, optimization and scale up at a CMO/CRO.
- Designs process characterization and process validation activities and writes regulatory filings summarizing this work.
- Works closely with internal MSAT, manufacturing, and quality to ensure successful technology transfer to CMO and provide support for cGMP manufacturing.
- Demonstrates excellent scientific writing skills to draft/review various reports including lab study reports, process development/characterization report, and memo supporting cGMP manufacturing/change control/deviation investigation.
- Demonstrates expert knowledge of scale up/scale down principles with respect to siRNA synthesis and purification.
Qualifications and experience:
- Preferred Bachelor’s degree with 8+ years of industry experience, Master’s degree with 6+ years of industry experience, PhD with 0-2 years of industry experience with a degree in organic chemistry or chemical engineering.
- Demonstrated strong expertise in techniques related to solid-phase synthesis of siRNA or other nucleic acid modalities. Experience with purification of nucleic acid products and statistical design of experiments (DOE) is a plus.
- Hands-on operational knowledge and experience using and troubleshooting DNA/RNA automated solid-phase synthesizers.
- Detailed understanding of the in-process analytical techniques for oligonucleotides.
- Experience working in a cGMP environment. Good documentation practices (GDP) and experience writing standard operating procedures, batch records, and reports.
*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, 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.