5 дней назад
Scientist II, Biologics Drug Product Development
84 500 - 162 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Scientist II, Biologics Drug Product Development (HPLC/UPLC): Developing and characterizing biologic drug product formulations, in-use studies, and manufacturing processes with an accent on formulation science, protein characterization, and chromatographic analysis. Focus on leading HPLC/UPLC systems, troubleshooting instrumentation and methods, interpreting experimental data, and supporting regulatory documentation for clinical programs.
Location: Onsite in South San Francisco, California, United States
Salary: $84,500–$162,000 per year
Company
develops medicines and solutions across immunology, oncology, neuroscience, and other therapeutic areas.
What you will do
- Lead biologics drug product development studies, including formulation screening, in-use studies, stability assessment, and manufacturing process support.
- Develop scientific understanding of formulation attributes and product quality through laboratory experimentation and data interpretation.
- Serve as the primary technical resource and owner for HPLC/UPLC systems within the Drug Product Development group.
- Troubleshoot chromatographic instruments, methods, and data acquisition systems while coordinating maintenance, qualification, and vendor support.
- Support Empower users, develop HPLC training materials, maintain SOPs, and provide technical guidance on HPLC-related matters.
- Document and present findings, author technical reports and SOPs, and contribute to regulatory documents, publications, and patent applications.
Requirements
- Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related discipline with 7+ years of relevant industry experience; or a related master’s degree with 5+ years of experience.
- Hands-on experience in biologics drug product development, including formulation development, characterization, and stability assessment.
- Strong understanding of protein degradation pathways and analytical approaches for assessing biologic product quality.
- Deep practical expertise with HPLC/UPLC across modalities such as RP, SEC, IEC, and HIC, including method development and troubleshooting.
- Experience with protein characterization and stability techniques such as CE-SDS, icIEF, HIAC, MFI, DLS, or SoloVPE, plus chromatography data systems such as Empower.
- Strong scientific communication, documentation, project-management, and data-analysis skills.
Nice to have
- Experience with in-use stability or clinical compatibility studies for biologic drug products.
- Experience with Design of Experiments for formulation and process optimization.
- Experience supporting IND, NDA, or BLA filings.
- Experience contributing to scientific publications, patent applications, automation, or data digitalization.
Culture & Benefits
- Collaborative laboratory environment with daily face-to-face interaction across scientific disciplines.
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) benefits for eligible employees.
- Eligibility to participate in short-term incentive programs.
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