Senior Director, Commercial Supply Chain

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $180k - $200k / year

⏰ Full Time

🟠 Senior

🔗 Supply Chain

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Notified

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

📣 Marketing

☁️ SaaS

🤝 B2B

Marketing • SaaS • B2B

Notified is a B2B SaaS company that provides media monitoring and communications software for PR and marketing teams. It helps organizations track media coverage, social mentions, and influencer activity; measure campaign performance and audience reach; and manage communications and stakeholder engagement across earned, owned, and social channels. Notified’s platform is used by enterprises and agencies to centralize insights, reporting, and workflows for public relations and corporate communications.

📋 Description

• Head the Commercial Manufacturing function • Provide technical and organizational leadership, project management, and oversight of commercial drug product and API manufacturing activities at contract manufacturers • Support scale-up, validation, launch, and continued supply of commercial products and samples • Manufacture drug products and API on-time and on-budget to meet forecasted sales volumes • Participate in Sales and Operations Planning to review sales/sample distribution and revise forecasts • Provide forecast updates to contract manufacturing organizations according to contract requirements • Provide monthly production and inventory reports to Finance for monthly close • Establish and oversee commercial manufacturing strategies and operational plans across projects • Participate in selection and qualification of third-party suppliers • Oversee commercial manufacturing operations at third-party service providers in a 100% outsourced business model • Prepare supporting documentation for global regulatory filings and provide technical support for Health Authority responses • Serve as a Drug Product Manufacturing subject matter expert and represent Commercial Manufacturing on the CMC Team • Collaborate with Quality Assurance and Regulatory Affairs to ensure compliance with GxP and global regulatory requirements • Ensure budget, schedules, and performance requirements are met • May hire, mentor, and develop staff according to future company needs

🎯 Requirements

• Advanced degree in pharmaceutical sciences, engineering, or related discipline • PhD highly preferred • Minimum of 15 years’ industry experience in cGMP drug product manufacturing • Experience in development and manufacturing of small molecule dosage forms • NDA experience required • Minimum of 10 years’ industry experience in manufacturing small molecule API according to cGMP regulations is ideal • Strong knowledge of US and EU cGMP requirements, ICH guidelines and best practices relating to drug products and API • Strong knowledge of formulation development and drug product manufacture across all phases of drug development from initial regulatory filings through registration, scale-up, validation, launch, and commercial supply • Up to 50% travel, frequently outside the local area and overnight

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • Time off • 401K • Participation in Mineralys incentive plans contingent on achievement of personal and company performance

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