10 дней назад
Executive Director, Pharmaceutical Development, Small Molecule (CMC)
247 000 - 337 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Executive Director, Pharmaceutical Development, Small Molecule (CMC): Leading pharmaceutical development strategy for a global small-molecule pipeline, covering formulation, drug product development, manufacturing readiness, and CMC innovation with an accent on regulatory alignment and commercialization readiness. Focus on advancing oral, parenteral, combination product, and other dosage-form programs, implementing emerging manufacturing technologies, and building organizational capability across the development function.
Location: Fully remote; can be performed from anywhere. Occasional travel for team meetings and events is expected, approximately 25%.
Salary: $247,000–$337,000 annual
Company
is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.
What you will do
- Lead the strategic direction and operating model for small-molecule Pharmaceutical Development within Technical Operations.
- Oversee formulation development, drug product process development, technology transfer, process validation, manufacturing readiness, and lifecycle management.
- Align global CMC regulatory strategies with clinical, commercial, and portfolio objectives.
- Drive innovation through emerging formulation technologies, advanced manufacturing approaches, digital tools, and external scientific partnerships.
- Provide executive oversight for oral, parenteral, combination product, and other advanced small-molecule dosage-form programs.
- Build relationships with CDMOs, technology partners, regulatory agencies, academic institutions, and industry experts while developing organizational talent and performance frameworks.
Requirements
- PhD with 10 years of CMC experience, MS with 12 years, or BS with 15 years of pharmaceutical industry experience.
- Extensive expertise in formulation development, process development, technology transfer, process validation, manufacturing sciences, regulatory strategy, and commercialization readiness.
- Experience with solid oral and liquid dosage forms, including pediatric, geriatric, and modified-release products.
- Thorough understanding of cGxP, CMC, ICH, and USP/EP/JP requirements.
- Experience authoring, reviewing, and approving CMC sections of INDs, NDAs/MAAs, and other regulatory documentation.
- Proven leadership in managing multiple programs, resources, and staff from early discovery through commercialization, with strong communication, negotiation, and influencing skills.
Nice to have
- Experience with inhalation and combination products.
Culture & Benefits
- Remote work with occasional purposeful in-person collaboration, team meetings, and events.
- Medical, dental, vision, and mental health coverage, plus wellbeing reimbursement and an Employee Assistance Program.
- Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
- 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
- Learning programs, mentorship, employee resource groups, service programs, and recognition opportunities.
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