2 дня назад
Senior Manager, Clinical Supplies Project Manager (Biotech)
130 800 - 209 400$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manager, Clinical Supplies Project Manager (Biotech): Managing clinical drug supply planning, packaging, labeling, distribution, IRT, and vendor operations across clinical programs with an accent on cold-chain logistics, forecasting, inventory control, and regulatory compliance. Focus on coordinating international shipments, resolving supply issues, overseeing vendors, and aligning production schedules with clinical trial needs.
Location: Cambridge, Massachusetts, United States; 70% in-office work model.
Salary: $130,800–$209,400 per year, plus potential bonus, incentive compensation, or equity.
Company
develops mRNA technology and medicines through a biopharmaceutical research and manufacturing platform.
What you will do
- Manage clinical drug supply logistics, including cold-chain packaging, labeling, shipment, depot and investigative-site distribution, and international transit.
- Plan and forecast clinical supply needs and align master production schedules with clinical trial requirements.
- Define and manage IRT requirements, user acceptance testing, inventory control, and distribution activities.
- Oversee third-party vendors, including procurement, packaging and labeling performance, delivery, quality, scope, and issue resolution.
- Develop KPIs, processes, SOP-compliant workflows, pharmacy manuals, and training materials for investigative sites.
- Collaborate with CMC, clinical, regulatory, functional leads, CROs, and therapeutic-area teams to meet program objectives.
Requirements
- 5–8 years of experience in clinical drug supply management, clinical supply chain, or clinical supplies in a clinical research environment.
- Bachelor’s degree in a science-based subject.
- Required experience with cold-chain packaging, labeling, distribution, IRT design and management, clinical supplies planning and forecasting, and clinical supply inventory management systems.
- Experience managing vendor relationships and participating in business review meetings.
- Working knowledge of ICH, FDA, IRB/IEC, applicable regulations, and clinical research protocol requirements.
- Proficiency with Microsoft Office tools, including Outlook, Word, Excel, PowerPoint, and SharePoint.
Nice to have
- Biopharmaceutical, pharmaceutical, or chemical manufacturing experience.
- Creative problem-solving skills and experience proposing improvements in clinical research operations.
Culture & Benefits
- In-person collaboration supported through a 70/30 work model.
- Healthcare and voluntary benefit programs.
- Fitness, mindfulness, and mental health resources.
- Family planning benefits, including fertility, adoption, and surrogacy support.
- Paid vacation, volunteer days, sabbatical, global recharge days, and a year-end shutdown.
- Savings and investment programs plus location-specific benefits.
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