2 дня назад
Director, CMC Product Lead (Biotech)
183 800 - 330 300$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director, CMC Product Lead (Biotech): Leading CMC development strategies and execution for multiple drug development assets from first-in-human through pivotal studies with an accent on technical development, manufacturing, quality, supply chain, and regulatory alignment. Focus on translating program strategy into actionable roadmaps, managing cross-functional risks and resources, and driving complex decisions across R&D, leadership, and manufacturing stakeholders.
Location: Norwood, Massachusetts, United States; 70/30 work model with 70% in-office collaboration.
Salary: $183,800–$330,300 annually, with potential bonus, incentive compensation, or equity.
Company
develops mRNA therapeutics and vaccines through its mRNA science, delivery technology, and manufacturing platform.
What you will do
- Define and communicate CMC development plans for products across therapeutic areas, from first-in-human through pivotal studies.
- Translate platform and program strategy into actionable CMC tasks, milestones, technical roadmaps, and portfolio priorities.
- Represent CMC on program teams and serve as the primary accountable owner for CMC plans and critical decisions.
- Lead technical discussions with leadership, R&D teams, governance bodies, and manufacturing sites.
- Contribute to CMC sections of global regulatory submissions and identify, escalate, and resolve cross-functional risks.
- Manage team resources, budgets, costs, delegation, and stakeholder relationships across the organization.
Requirements
- PhD with 10+ years, MS with 12+ years, or BS/BA with 15+ years of relevant experience.
- Leadership experience in CMC or product development within the biotechnology or pharmaceutical industry.
- Strong knowledge of technical development, manufacturing, supply chain, quality, process development, and CMC regulatory activities.
- Demonstrated ability to lead cross-functional teams and complex projects with strategic and operational impact.
- Technical depth in drug development, executive influence, stakeholder management, negotiation, and decision-making.
- Ability to work in the United States and meet applicable U.S. export-control requirements.
Nice to have
- PhD in biochemistry, chemistry, biology, pharmaceutical sciences, or a related field.
- Thought leadership in program strategy and tactics, with the ability to operate through ambiguity and organizational change.
Culture & Benefits
- In-person collaboration supported through a 70/30 office-based working model.
- Healthcare and voluntary benefit programs.
- Fitness, mindfulness, mental health, family planning, fertility, adoption, and surrogacy support.
- Paid vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
- Savings and investment programs, plus location-specific perks.
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