Senior Scientist I, Drug Product and Device Development jobs in United States
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Vir Biotechnology, Inc. · 5 hours ago

Senior Scientist I, Drug Product and Device Development

Vir Biotechnology is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives. They are seeking a Senior Scientist I to lead formulation development and process optimization for drug products, collaborating with cross-functional teams to advance pipeline assets from discovery through development.

BiotechnologyHealth CareMedicalTherapeutics
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Comp. & Benefits
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Responsibilities

Scientific leadership of formulation development and process optimization for parenteral dosage forms of monoclonal antibodies and biologics, ensuring robustness, stability, and scalability
Design and execute in-house laboratory studies, including formulation screening, in-use stability studies, and analytical characterization, leveraging advanced experimental designs (DoE) and statistical methods
Provide technical direction and oversight for internal and external drug product development and manufacturing activities, including data review, trouble-shooting, and risk assessment
Lead technical transfer of manufacturing processes at contract manufacturing organizations, managing cross-functional alignment and proactively addressing challenges
Author and review high-impact technical reports, regulatory submissions, and scientific publications, ensuring clarity, accuracy, and regulatory compliance
Represent Drug Product and Formulation and Device Development on cross-functional program teams, actively contributing to strategy, timelines, and issue resolution in collaboration with clinical, process development, analytical, quality, and regulatory stakeholders
Ensure consistent scientific oversight for data generated by internal teams and contract research/manufacturing organizations, upholding best practices and industry standards
Drive continuous improvement initiatives and implement new technologies or methodologies to strengthen group capabilities

Qualification

Formulation developmentDrug product developmentLyophilizationExperimental design (DoE)Analytical methodsPharmaceutical developmentTechnical project leadershipData analysisMentoringCross-functional collaboration

Required

PhD with 5+ years, Master's with 8+ years' or Bachelor's with 10+ years' experience, in Biosciences, Pharmaceutical Technology, Biochemistry, Chemistry, Chemical Engineering, or a related discipline
Demonstrated expertise in formulation and drug product development for monoclonal antibodies and biologics required
Proficiency in experimental design (DoE), data analysis, and use of statistical programs for formulation screening and optimization
Strong working knowledge of analytical methods supporting formulation assessments
Possess a solid understanding of pharmaceutical development, particularly as related to biological drug development
Experience authoring development reports, batch records, SOPs, regulatory filings, or other documents
Previous experience representing Drug Product and formulation on inter-disciplinary teams and with external collaborations
Experience leading technical projects and mentoring junior team members

Preferred

Hands-on experience with lyophilization and prefilled syringe development strongly preferred

Benefits

Health and welfare benefit plans
Non-accrual paid time off
Company shut down for holidays
Commuter benefits
401K match
Lunch each day in the office

Company

Vir Biotechnology, Inc.

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At Vir Biotechnology, Inc., we leverage the immense potential of the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer.

Funding

Current Stage
Public Company
Total Funding
$908.6M
Key Investors
Biomedical Advanced Research and Development Authority (BARDA)Bill & Melinda Gates FoundationGlaxoSmithKline
2023-10-03Grant· $50M
2023-05-02Grant· $10M
2022-10-04Grant· $55M

Leadership Team

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Marianne De Backer
Chief Executive Officer
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Louis Picker
Co-Founder
Company data provided by crunchbase