Scientist I, Stability & Data Analytics (Temporary)

Vir Biotechnology

San Francisco (CA)

On-site

USD 77,000 - 96,000

Full time

7 days ago
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Job summary

Vir Biotechnology, Inc. is seeking a Scientist I, Stability and Data Analytics (Temporary, 12+ month contract) to support clinical and commercial stability programs across diverse modalities.

The role manages stability studies at external labs and partners, reviews data, and supports data management within LIMS. Based in San Francisco, CA, onsite three days per week, cross-functional collaboration with Analytical Development, Quality, Regulatory, and Supply Chain to ensure timely, compliant

Qualifications

  • Stability studies experience in biotech/pharma
  • Familiarity with ICH guidelines
  • Experience with LIMS or similar platforms (Veeva LIMS preferred)

Responsibilities

  • Support stability programs for clinical and commercial products
  • Coordinate stability studies at CDMOs/CLOs and track samples
  • Review stability data for trends and shelf-life implications
  • Assist with protocol creation and study documentation
  • Investigate stability results, excursions, and out-of-trend findings
  • Maintain stability data in LIMS and metadata
  • Collaborate with internal and external partners to ensure timely testing
  • Prepare summaries and reports for internal teams and regulatory submissions

Skills

Analytical thinking
Data quality
Multi-project management
Regulatory knowledge
cGMP knowledge

Education

Bachelor's degree + 6+ years
Master's degree + 4+ years
PhD candidates with relevant training

Tools

LIMS
Veeva LIMS
Electronic data systems

Job description

Scientist I, Stability & Data Analytics (Temporary)

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.

For hires based in the United States, Vir Biotechnology, participates in E-Verify .

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