VP of 503B Services

Stelle nicht auf LinkedIn

🕒 vor 2 Monaten

🇺🇸 Vereinigte Staaten – Remote

💵 $150.000 - $200.000 / Jahr

⏰ Vollzeit

🔴 Experte

👔 Vizepräsident

👻 Geisterscore 23%

Was es bedeutet: wie wahrscheinlich diese Stelle offen bleibt, ohne dass aktiv eingestellt wird.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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Revelation Pharma

WebsiteLinkedInAlle Stellen

201 - 500 Mitarbeiter

Gegründet 2020

🏥 Gesundheitswesen

🏭 Fertigung

💊 Pharmazie

Healthcare • Manufacturing • Pharmaceuticals

Revelation Pharma ist ein nationales Netzwerk von 503A- und 503B-Rezepturarzneimittel-Apotheken, das sich der Bereitstellung innovativer und qualitativ hochwertiger Apothekenpräparate und -dienstleistungen widmet. Ihr Ziel ist es, die Führung in der Branche der Rezepturarzneimittel-Apotheken zu übernehmen, indem sie sich auf patientenorientierte Betreuung konzentrieren und Wachstums- und Kooperationsmöglichkeiten unter Apotheken erkunden. Ihre Mission beinhaltet das Engagement zur Verbesserung des Apothekengeschäfts und die Sicherstellung eines nahtlosen Übergangs für diejenigen, die an einem Verkauf oder einer Partnerschaft mit renommierten Rezepturarzneimittel-Apotheken interessiert sind.

Beschreibung

• Build, scale, and optimize Revelation Pharma’s 503B outsourcing facility network • Lead real estate evaluation and site selection for new 503B outsourcing facilities • Develop and own the facility development playbook and project governance standards • Manage capital projects from architectural programming and design review through construction, commissioning, validation, registration, and production launch • Partner with Regulatory Affairs on state Board of Pharmacy licensure, DEA registration, and federal 503B registration • Build business cases and capital expenditure requests with ROI modeling, capacity projections, and risk-adjusted timelines • Define and execute network automation strategy, including robotic dispensing, automated filling and finish systems, MES/ERP integration, and environmental monitoring • Lead automation vendor selection, contract negotiation, installation qualification, operator training, and change control • Establish technology standards and approved-vendor lists for compounding automation • Maintain FDA inspection readiness and oversee FDA Form 483 responses, warning letter remediation, and CAPA programs • Partner with Quality Assurance on SOPs, batch records, environmental monitoring, and deviation management • Own network-level production P&L and drive EBITDA performance through COGS, labor efficiency, throughput, and waste management • Lead production scaling across sites and develop production KPIs • Oversee lean manufacturing and continuous improvement programs including 5S, Kaizen, and Six Sigma • Align production scheduling with customer demand and communicate capacity constraints • Serve as operational SME for 503B-related M&A activity • Lead operational due diligence, acquisition valuation input, and post-acquisition integration • Build and lead the 503B operations organization, including Directors, Site General Managers, and project/engineering functions • Develop leaders through performance expectations, development plans, and coaching • Conduct regular site visits and partner with HR on compensation benchmarking, retention, and succession planning • Report directly to the COO

🎯 Anforderungen

• PharmD, Bachelor’s degree in Pharmacy, or B.S./M.S. in Engineering required • Minimum 10 years of progressive leadership experience in 503B outsourcing pharmacy, pharmaceutical manufacturing, or high-volume sterile compounding, with demonstrated multi-site accountability • Proven track record of building or scaling 503B outsourcing operations across more than one location • Direct experience owning facility development from site selection through regulatory registration and production launch • Direct experience overseeing construction, cleanroom design, and commissioning of USP 797/800-compliant facilities, including IQ/OQ/PQ and FDA outsourcing facility registration • Demonstrated experience identifying, selecting, and implementing automation in compounding or pharmaceutical manufacturing environments • Direct experience with FDA inspections, cGMP compliance programs, 21 CFR Parts 210/211, and USP chapters 795/797/800 required • Strong capital project management skills, including business case development, CapEx management, contractor oversight, and on-time/on-budget delivery • Proven people leadership experience developing multi-level teams and building leadership bench strength in complex, regulated environments • Strong financial acumen with experience owning operational P&L, managing capital budgets, and driving EBITDA performance • Exceptional executive presence and ability to represent 503B operations to regulators, health system customers, investors, and the Board • MBA or equivalent business training strongly preferred • Experience supporting or leading M&A activity in a pharmaceutical, compounding, or healthcare services context strongly preferred

🏖️ Vorteile

• Laptop • Mobile device • Secure remote access to all operational and quality systems • Travel budget supporting approximately 50% travel to facility and project sites nationwide • Access to ERP/MES, QMS, environmental monitoring platforms, and executive reporting infrastructure • Capital project management tooling • Approved vendor relationships for construction and automation procurement