3 дня назад
Associate Director, CMC Project Management (Biotech)
193 500 - 236 500$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Associate Director, CMC Project Management (Biotech): Driving cross-functional CMC planning and execution across drug development programs, including manufacturing timelines, regulatory filings, risk management, and collaboration with CMOs, with an accent on small-molecule development, quality systems, and program governance. Focus on coordinating complex matrixed teams, resolving cross-functional risks, and enabling regulatory and clinical supply milestones through commercialization.
Location: South San Francisco, California; hybrid role. Must be authorized to work in the United States.
Annual salary: $193,500–$236,500, plus eligibility for an annual performance bonus.
Company
is a clinical-stage biopharmaceutical company developing precision medicines for kidney and metabolic diseases by applying human genetics and small-molecule drug discovery.
What you will do
- Provide end-to-end CMC project management across the drug development lifecycle.
- Lead cross-functional teams covering chemical and pharmaceutical development, analytical development, quality, regulatory CMC, manufacturing, and clinical supply chain.
- Coordinate CMO meetings, action items, workstream dependencies, timelines, and program status.
- Own risk registries, mitigation plans, escalation, governance materials, and senior leadership recommendations.
- Support IND, IMPD, and other regulatory filing preparation with Regulatory CMC and partner functions.
- Improve project management processes, governance frameworks, dashboards, budget tracking, and financial forecasting.
Requirements
- Bachelor's degree in life sciences, science, technology, engineering, business, or a related discipline; an advanced degree is preferred.
- At least 10 years of professional experience, including 5 years in project management within pharmaceutical, biotechnology, or medical device industries.
- At least 3 years managing cross-functional teams in a matrixed organization and delivering complex programs.
- Working knowledge of CMC functions, drug development from Pre-IND through NDA and commercialization, clinical development, and regulatory requirements.
- Familiarity with GMP/GxP environments, quality management systems, and preferably small-molecule modalities.
- Must be authorized to work in the United States. Strong communication, organization, prioritization, and influencing skills are required.
Nice to have
- Experience with late-stage or commercial programs.
- PMP certification.
- Experience in startup or growth-stage biotechnology environments.
- Advanced degree in a relevant discipline.
Culture & Benefits
- Collaborative, patient-focused environment with emphasis on integrity, resilience, initiative, and continuous improvement.
- Medical, dental, vision, and mental health benefits for eligible employees.
- Equity incentive plan and 401(k) program with employer match.
- Generous holiday and paid time off policy.
- Annual performance bonus eligibility.
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