Head of Design, Development, and Construction

🕒 il y a 10 jours

🇺🇸 États-Unis – Télétravail

💵 $140 000 - $165 000 / an

⏰ Temps Plein

🔴 Expert

🎨 Designer Produit (UI/UX)

🗣️🇺🇸🇬🇧 Anglais requis

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Repérée par Remote Rocketship il y a 10 jours

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Gilbert Pharmaceuticals

11 - 50 employés

💊 Pharmaceutique

🏥 Santé

🏗️ Construction

Pharmaceuticals • Healthcare • Construction

Gilbert Pharmaceuticals est un partenaire qui aide les pharmacies de préparation magistrale à créer, gérer et développer leur activité grâce à des services couvrant l’ensemble du projet : conception des installations, approvisionnement, construction, exploitation et conformité réglementaire. L’entreprise accompagne les propriétaires de pharmacies depuis la sélection du site et la conception des installations jusqu’à l’approvisionnement, la gestion de la construction, la mise en service, ainsi que le conseil au quotidien en matière d’exploitation et de conformité, avec une attention particulière portée aux exigences des State Boards of Pharmacy et de la FDA (notamment les exigences 503A et 503B / cGMP). Gilbert réunit des compétences en conception et en ingénierie, en procurement, en construction management et en conseil en conformité afin de fournir des pharmacies de préparation magistrale clés en main, prêtes pour les inspections, ainsi que des procédures opérationnelles directement applicables.

Description

• Own the end-to-end process of launching new compounding pharmacies nationally. • Lead market analysis, site selection, feasibility assessments, due diligence, entitlement strategy, and lease/site acquisition coordination. • Navigate land use and zoning requirements, master plan coordination, environmental compliance, community outreach, and public hearings. • Coordinate regulatory submissions and facility inspections and approvals with state Boards of Pharmacy, DEA, FDA, and local authorities. • Develop and maintain facility compliance playbooks for new site design and existing facility modifications. • Lead concept, programming, architectural design, space planning, and design standards for pharmacy facilities, including compounding suites, sterile and non-sterile areas, clean rooms, and dispensing environments. • Manage architects, MEP engineers, specialty consultants, contractors, and other design and construction partners. • Review and approve architectural drawings, construction documents, engineering plans, HVAC, cleanroom, airflow, and environmental monitoring specifications. • Design scalable 503A and 503B production environments with batch manufacturing areas, quarantine/release zones, and controlled material flow segregation. • Develop project budgets, oversee value engineering, select general contractors, manage permits, timelines, procurement schedules, and risk mitigation. • Serve as Owner’s representative during construction, overseeing design intent, budget, schedule, site inspections, quality walkthroughs, change orders, contractor performance, FF&E installation, and commissioning. • Manage QA and closeout activities, including installation qualifications for critical manufacturing utilities. • Drive operational readiness with pharmacy operations and quality teams to ensure inspection-ready facilities. • Maintain as-built drawings, equipment lists, SOPs, and facility documentation. • Assess pharmacy partners’ existing facilities for design and regulatory readiness. • Report to the Director of Pharmacy Development & Operations.

🎯 Exigences

• Bachelor’s degree in Architecture, Engineering (Mechanical, Civil, or Chemical), Pharmacy, or a closely related field; advanced degree or licensure preferred. • 5+ years of experience designing, building, or commissioning pharmacy facilities, healthcare environments, or regulated laboratory/cleanroom spaces. • Ability to understand/learn USP <795>, USP <797>, USP <800>, and applicable state Board of Pharmacy facility requirements. • Demonstrated project management experience overseeing construction projects from design through commissioning. • Experience interfacing with regulatory agencies on facility approvals and inspections. • Proficiency with architectural drawings, construction documents, and facility engineering specifications. • Experience designing or supporting sterile manufacturing or 503B outsourcing facilities operating under cGMP environments strongly preferred. • Ability to travel to pharmacy sites as needed for construction oversight, inspections, and go-live support. • Licensed Architect (AIA), Professional Engineer (PE), or Certified Pharmaceutical Industry Professional (CPIP) preferred. • Familiarity with digital health or telehealth-linked pharmacy models. • Strong vendor management experience working with contractors, engineers, and equipment suppliers.

🏖️ Avantages

• Equity • Bonus structure • Base salary

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