Senior Director, Analytical Sciences

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $215k - $240k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 0%

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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

• Provide strategic and technical leadership for analytical activities supporting development, registration, validation, launch, and lifecycle management of the company's small molecule drug substance and drug product portfolio. • Set and lead analytical direction across the portfolio using risk-based, phase-appropriate, fit-for-purpose approaches. • Serve as the company subject matter expert for analytical chemistry and pharmaceutical analysis. • Develop and execute integrated analytical strategies for drug substance, drug product, raw materials, impurities, and reference standards. • Own method development, qualification, validation, transfer, verification, and lifecycle management. • Establish specifications, impurity control, characterization, reference standards, and stability programs. • Lead OOS/OOT investigations, deviations, CAPAs, and complex analytical troubleshooting. • Lead selection, governance, and review of external analytical partners, including CDMOs, CROs, and contract testing laboratories. • Author, review, and approve analytical content for global regulatory submissions and support Health Authority questions, audits, and inspections. • Ensure external partners comply with cGMP requirements, quality agreements, and company standards. • Drive analytical readiness for process validation, launch, continued process verification, and post-approval changes. • Partner with Drug Substance, Drug Product, Quality, Regulatory, Supply Chain, and Program Management teams on integrated CMC plans. • Manage budgets, timelines, resources, and technical risk across programs; build and mentor the team as the organization grows.

🎯 Requirements

• Ph.D in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or a related scientific discipline; an M.S. with substantial directly relevant experience may be considered. • Typically 15 or more years of relevant pharmaceutical or biotechnology industry experience, including progressively responsible leadership in analytical development or analytical sciences. • Demonstrated experience supporting small molecule products from development through regulatory submission, approval, launch, and commercial lifecycle management. • Deep expertise in analytical method development, validation, transfer, stability, specifications, and impurity control for drug substance and drug product. • Strong working knowledge of cGMP requirements, ICH guidelines, compendial expectations, data integrity principles, and global CMC regulatory requirements. • Proven ability to lead external analytical partners and manage budgets, timelines, and technical risks across multiple programs. • Excellent written, verbal, and executive-level communication skills. • Up to 10% travel, frequently outside the local area and overnight. • Preferred: experience in a virtual, externally networked, or substantially outsourced pharmaceutical operating model. • Preferred: experience with oral solid dosage forms, late-stage development, process validation, and commercial launch readiness. • Preferred: experience building an Analytical Sciences function and establishing scalable governance and operating processes.

🏖️ Benefits

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

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