Senior Director, Commercial Manufacturing, Science and Technology

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🕒 Maio 20

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CultureHQ

SiteLinkedInTodas as Vagas

1 - 10 funcionários

Fundada em 2017

☁️ SaaS

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Descrição

• Oversee late phase through commercialization small molecule drug product manufacturing at partner CDMOs. • Serve as a technical expert for the transfer of manufacturing processes to commercial scale. • Manage compliance with safety and regulatory standards. • Provide oversight for process validation, lifecycle management, and continuous improvement. • Anticipate and solve complex manufacturing issues. • Collaborate with internal and external stakeholders including CMC, Quality, Supply Chain, Regulatory, and CDMOs. • Lead commercial drug product CMC lifecycle activities such as post-approval change management.

🎯 Requisitos

• PhD, MS or BS in chemical engineering, pharmaceutical sciences or related field with an exceptional understanding of drug product development and manufacturing for small molecule solid oral dosage forms. • 20+ years of biotechnology and/or pharmaceutical industrial experience in CMC/cGMP environment. • 12+ years of management and oversight of CDMOs for cGMP activities for late stage and commercial assets. • Experience in manufacturing techniques such as advanced drug delivery systems for enhancing drug permeability and/or solubility and other manufacturing processes including blending, granulation, tablet compression, film coating etc. • Extensive experience in outsourcing, vendor selection and managing CMOs for scale up, tech transfer, process validation, and commercial manufacturing. • Extensive knowledge of cGMP requirements for drug product manufacture and broader drug development guidelines (ICH, FDA, and EMA) and past experience in regulatory filings. • Excellent oral and written communication skills. • Attention to detail and quality with critical thinking. • Ability to navigate and craft global regulatory CMC documents. • Familiarity with safe and efficient laboratory practices. • General and scientific computer and software application proficiency. • Up to 30% travel.

🏖️ Benefícios

• We cover 100% of medical, dental, and vision premiums for you and your family. • Help reduce out-of-pocket costs by funding up to 75% of in-network deductibles. • A 401(k) match with immediate vesting. • Generous paid time off. • 12 weeks of fully paid parental leave. • Paid family and medical leave for all employees regardless of location. • Company-paid short-term disability coverage for up to 20 weeks. • Additional perks like wellness programs, tuition reimbursement, and inclusive family-forming support.