3 дня назад
Associate Director, Chemical Engineering
189 800 - 216 700$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Director, Chemical Engineering (Small-Molecule Drug Substance Manufacturing): Leading 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 technology transfer, troubleshooting engineering and validation batches, defining critical process parameters and quality attributes, and managing regulatory CMC documentation.
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 through an AI-integrated discovery platform.
What you will do
- Lead end-to-end chemical engineering support for bexobrutideg drug substance from late-stage development through commercial launch.
- Design, develop, and optimize scalable small-molecule manufacturing routes, including unit operations, process modeling, equipment selection, and scale-up.
- Oversee CDMO facility and equipment operations, qualification, maintenance, technology transfer, troubleshooting, and manufacturing scale-up.
- 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 strategies, DoE, and QbD.
- Review manufacturing documentation and regulatory CMC sections, 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.
- Extensive experience in GMP small-molecule drug substance manufacturing, process development, characterization, equipment evaluation, scale-up, and process validation.
- Knowledge of solid-state properties, polymorphism, and crystallization principles.
- Experience managing third-party drug substance CDMOs, including technology transfer, QbD and DoE studies, clinical supply, registration batches, and commercial launch.
- In-depth knowledge of cGMP, ICH, FDA, and EMA guidelines, with strong communication, collaboration, problem-solving, and conflict-management skills.
- Ability to work onsite in Brisbane, California, and travel up to 25%.
Culture & Benefits
- Collaborative, strongly team-oriented environment.
- Solutions- and results-oriented approach.
- Hands-on, resourceful culture open to diverse points of view.
- Opportunity to provide technical leadership across development, manufacturing, regulatory, and commercial activities.
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