Scientist I, Stability & Data Analytics (Temporary)
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What you'll do
- Support clinical and commercial stability programs for biologics and other therapeutic modalities
- Coordinate and manage stability studies at CDMOs/CLOs, including study initiation, sample tracking, data review, and issue resolution
- Review stability data, identify trends, and assist with data analysis to support shelf-life assignments and product investigations
- Support stability protocol creation, amendments, and study documentation
- Assist with investigation activities related to stability results, temperature excursions, and out-of-trend findings
- Maintain stability data and metadata within LIMS system, including batch release and stability modules
- Collaborate with internal stakeholders and external partners to ensure stability testing is executed according to approved protocols and timelines
- Prepare summaries, reports, and presentations of stability data for internal teams and regulatory submissions
What they're looking for
- Bachelor's degree with 6+ years of relevant industry experience; or a Master's degree with 4+ years of experience; or PhD candidates with relevant training
- Experience supporting stability studies, analytical testing, quality control, or CMC development activities in a biotechnology or pharmaceutical environment
- Familiarity with stability program requirements and ICH guidelines
- Experience working with laboratory information management systems (LIMS), electronic data systems, or similar platforms. Experience with Veeva LIMS is a plus
- Strong analytical and problem-solving skills with attention to detail and data quality
- Ability to organize and manage multiple projects and priorities in a fast-paced environment
- Knowledge of cGMP and regulatory requirements applicable to biologics and pharmaceutical development is preferred
Nice to have
- Experience with Veeva LIMS is a plus
- Knowledge of cGMP and regulatory requirements applicable to biologics and pharmaceutical development is preferred
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies.
Vir Biotechnology has exclusive rights to the universal PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.
We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best.
THE OPPORTUNITY
Vir Biotechnology is looking for a motivated Temporary Scientist I, Stability and Data Analytics (12 month+ initial contract) to support clinical and commercial stability programs across a diverse portfolio of therapeutic modalities. This role is critical to the successful execution of stability studies supporting regulatory submissions, product lifecycle management, and Vir Bio’s pipeline.
You will be responsible for managing stability studies conducted at external laboratories and manufacturing partners, reviewing and trending stability data, and supporting data and metadata management within LIMS. This role offers the opportunity to work cross-functionally with Analytical Development, Quality, Regulatory, Supply Chain, and external partners to ensure high-quality stability program execution.
This role is based in our San Francisco, California office with the expectation to be onsite three days per week.
WHAT YOU'LL DO
- Support clinical and commercial stability programs for biologics and other therapeutic modalities
- Coordinate and manage stability studies at CDMOs/CLOs, including study initiation, sample tracking, data review, and issue resolution
- Review stability data, identify trends, and assist with data analysis to support shelf-life assignments and product investigations
- Support stability protocol creation, amendments, and study documentation
- Assist with investigation activities related to stability results, temperature excursions, and out-of-trend findings
- Maintain stability data and metadata within LIMS system, including batch release and stability modules
- Collaborate with internal stakeholders and external partners to ensure stability testing is executed according to approved protocols and timelines
- Prepare summaries, reports, and presentations of stability data for internal teams and regulatory submissions
WHO YOU ARE AND WHAT YOU BRING
- Bachelor's degree with 6+ years of relevant industry experience; or a Master's degree with 4+ years of experience; or PhD candidates with relevant training
- Experience supporting stability studies, analytical testing, quality control, or CMC development activities in a biotechnology or pharmaceutical environment
- Familiarity with stability program requirements and ICH guidelines
- Experience working with laboratory information management systems (LIMS), electronic data systems, or similar platforms. Experience with Veeva LIMS is a plus
- Strong analytical and problem-solving skills with attention to detail and data quality
- Ability to organize and manage multiple projects and priorities in a fast-paced environment
- Knowledge of cGMP and regulatory requirements applicable to biologics and pharmaceutical development is preferred
WHO WE ARE AND WHAT WE OFFER
The expected hourly range for this position is $56.00 to $70.00 per hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to any legally protected characteristics.
This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.
Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology. Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us 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.
For hires based in the United States, Vir Biotechnology, participates in E-Verify.
Company
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