11 дней назад
Associate Director, Chemical Engineering (Biotech)
189 800 - 216 700$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Director, Chemical Engineering (Biotech): Providing end-to-end chemical engineering support for bexobrutideg drug substance from late-stage development through commercial launch with an accent on process optimization, equipment scale-up, CDMO oversight, and GMP manufacturing. Focus on leading technology transfer, troubleshooting engineering and production batches, authoring CMC regulatory content, and driving process robustness and cost-of-goods optimization.
Location: Brisbane, California, United States — onsite; travel up to 25% of the time.
Salary: $189,800–$216,700 per year
Company
is a clinical-stage biopharmaceutical company developing targeted protein degradation medicines for cancer and inflammatory diseases using an AI-integrated discovery engine.
What you will do
- Provide chemical engineering leadership for scalable small-molecule drug substance manufacturing routes, including unit operation design, process modeling, equipment selection, and scale-up.
- Oversee facility and equipment operations at external CDMOs, including qualification, maintenance, engineering support, and performance monitoring.
- Lead technology transfer, process troubleshooting, engineering batches, clinical and registration batches, PPQ batches, and commercial scale-up activities.
- Partner with CMC, Quality Assurance, and Global Supply Chain teams to support timely drug substance manufacture and lot release.
- Drive process understanding using critical process parameters, critical quality attributes, control strategy, DoE, and QbD principles.
- Review manufacturing documentation and regulatory filings, define long-term engineering strategy, and mentor scientists and engineers.
Requirements
- Ph.D. in chemical engineering or a related field with at least 5 years of relevant industrial experience; alternatively, an M.S. with 10 years or a B.S. with 15 years of experience.
- Extensive experience in GMP drug substance manufacturing, process development, equipment evaluation, scale-up, process validation, and small-molecule development.
- Knowledge of solid-state properties, polymorphism, and crystallization principles.
- Significant experience managing third-party drug substance CDMOs, including technology transfer, QbD and DoE studies, clinical supply, registration batches, and commercial launches.
- In-depth knowledge of cGMP, ICH, FDA, and EMA guidelines, plus strong communication, collaboration, problem-solving, and conflict-management skills.
- Ability to work onsite in Brisbane, California and travel up to 25%.
Culture & Benefits
- Highly collaborative, team-oriented environment.
- Solutions- and results-oriented culture.
- Hands-on, resourceful approach with openness to diverse perspectives.
- Opportunity to contribute across late-stage development, commercial launch, and lifecycle management.
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