Senior Director, Analytical Sciences

Stelle nicht auf LinkedIn

🕒 vor 4 Tagen

🇺🇸 Vereinigte Staaten – Remote

💵 $215.000 - $240.000 / Jahr

⏰ Vollzeit

🟠 Senior

👔 Direktor

👻 Geisterscore 0%

Was es bedeutet: die Wahrscheinlichkeit, dass für diese Stelle niemand wirklich einstellt.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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Notified

WebsiteLinkedInAlle Stellen

1001 - 5000 Mitarbeiter

Gegründet 2004

📣 Marketing

☁️ SaaS

🤝 B2B

Marketing • SaaS • B2B

Notified ist ein B2B-SaaS-Unternehmen, das Software für Media Monitoring und Communications für PR- und Marketingteams anbietet. Unternehmen können damit Medienberichterstattung, Social-Media-Erwähnungen und die Aktivitäten von Influencern verfolgen, die Kampagnenperformance und Reichweite messen sowie ihre Kommunikation und ihr Stakeholder-Engagement über Earned-, Owned- und Social-Kanäle hinweg steuern. Die Plattform von Notified wird von Unternehmen und Agenturen genutzt, um Insights, Reporting und Workflows für Public Relations und Corporate Communications zentral zu bündeln.

Beschreibung

• 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.

🎯 Anforderungen

• 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.

🏖️ Vorteile

• 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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