Senior Director, Commercial Manufacturing, Science and Technology

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CultureHQ

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1 - 10 Mitarbeiter

Gegründet 2017

☁️ SaaS

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CultureHQ ist eine webbasierte Anwendung; der angegebene Text weist lediglich darauf hin, dass die Anwendung JavaScript benötigt, um zu funktionieren. Es wurden keine weiteren Informationen über das Angebot des Unternehmens, die Zielkunden oder die Branche bereitgestellt.

Beschreibung

• 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.

🎯 Anforderungen

• 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.

🏖️ Vorteile

• 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.