4 дня назад
CMC Demand & Supply Leader (Biopharma)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
CMC Demand & Supply Leader (Biopharma): Integrating clinical, CMC, and operational plans to forecast end-to-end demand and optimize supply strategies with an accent on clinical supply planning, sourcing, regulatory requirements, and risk-cost analysis. Focus on defining supply scenarios, allocating drug substance and drug product batches, managing material flow and documentation, and improving supply performance through KPIs.
Location: Framingham, Massachusetts, United States; onsite
Company
is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines across multiple therapeutic areas.
What you will do
- Lead collaboration with Global Project Management, Clinical Development, and CMC to define clinical assumptions and forecast demand.
- Consolidate non-clinical and clinical demand and align development demand with CMC, clinical supply chain, operational, and regulatory plans.
- Run demand and supply scenarios covering risks, costs, strategic decisions, and budget definition.
- Co-lead the Demand & Supply Sub-Team and define sourcing and supply strategies for marketed products and comparators.
- Define drug product blinding strategies and allocate drug substance and drug product batches to investigational medicinal product batches.
- Oversee delivery to packaging sites, material flow, documentation, reporting, and supply performance KPIs.
Requirements
- PhD, MS, or BS in a relevant life sciences, pharmaceutical, chemical engineering, or biomedical engineering discipline.
- At least 3 years of R&D or Clinical Development experience with a PhD, 5 years with an MS, or 8 years with a BS.
- At least 2 years of Demand Management experience in R&D in oncology, immuno-inflammation, rare disease, neurology, or multiple sclerosis.
- CMC experience and the ability to work in regulated GMP and GCP environments.
- Knowledge of data analytics, forecasting, and project management.
Nice to have
- Experience with mammalian, genomic, microbial, or synthetic modalities.
- PMI certification and experience with Power BI, Power Apps, or project management software.
- Experience with co-development projects, company integrations, contract management, and industrial supply chain principles.
- Team management experience and strong cross-functional collaboration skills.
Culture & Benefits
- Supportive, future-focused environment focused on advancing drug development.
- Career growth opportunities through promotion or lateral moves, locally and internationally.
- Rewards package with healthcare, prevention, and wellness benefits.
- At least 14 weeks of gender-neutral parental leave.
- Work with AI, data, and digital platforms at the forefront of drug discovery.
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