6 дней назад
Senior Scientist, Formulation Development (Biologics)
160 000 - 180 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Scientist, Formulation Development (Biologics): Developing robust liquid and lyophilized biologic drug product formulations from early development through commercialization with an accent on protein stability, formulation optimization, and high-throughput Design of Experiments studies. Focus on characterizing degradation pathways, managing CMO development and scale-up, and authoring CMC documentation for IND and BLA submissions.
Location: Bothell, Washington, United States; domestic and international travel up to 10% may be required.
Salary: $160,000–$180,000 annually for potential hires working or residing in Washington, plus eligibility for a 15% bonus target and long-term incentive plan.
Company
Global biopharmaceutical company focused on research, development, manufacturing, and commercialization of treatments for brain diseases.
What you will do
- Develop robust liquid and lyophilized formulations for biologic drug products.
- Design, execute, and interpret formulation screening studies using Design of Experiments and statistical software.
- Evaluate protein physical and chemical stability using analytical characterization techniques and investigate degradation pathways.
- Collaborate with internal development functions and external manufacturing partners on drug product process development, technology transfer, scale-up, and commercialization.
- Manage outsourced formulation development and provide technical oversight to Contract Manufacturing Organizations.
- Prepare and present formulation reports, protocols, technical documents, regulatory submissions, and project updates.
Requirements
- Ph.D. with 5+ years of relevant biopharmaceutical industry experience, M.S. with 10+ years, B.S. with 12+ years, or an equivalent combination.
- Demonstrated expertise in biologic drug product formulation development, protein stability, aggregation, and degradation mechanisms.
- Experience with high-throughput formulation screening and Design of Experiments.
- Hands-on experience with SEC-HPLC, IEX-HPLC, DLS, MFI or HIAC, and related protein characterization methods.
- Ability to independently manage laboratory studies, analyze complex datasets, document results, and collaborate across scientific and operational functions.
- Strong scientific problem-solving, communication, and collaboration skills.
Nice to have
- Experience with lyophilized biologic products and lyophilization process development.
- Experience supporting commercial or late-stage biologics development.
- Working knowledge of JMP or equivalent statistical software.
- Experience authoring and reviewing CMC sections for IND, BLA, or MAA submissions.
- Familiarity with GMP manufacturing and Quality systems.
Culture & Benefits
- Flexible paid time off.
- Medical, dental, and vision benefits.
- Company-matched 401(k).
- Eligibility for a 15% bonus target and long-term incentive plan.
- Work focused on advancing brain health and transforming lives.
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