Gilbert Pharmaceuticals: Head of Design & Development & Construction Gilbert Pharmaceuticals

Mosaec; Northern (KY); Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

Gilbert Pharmaceuticals seeks a Senior leader to own the end‑to‑end process of launching new compounding pharmacies nationwide. The role covers site selection, feasibility, budgeting, design team selection, project management, build‑out, and regulatory readiness for 503A and 503B facilities, including FDA cGMP considerations.

The candidate will bridge pharmacy operations with construction and regulatory compliance, ensuring facilities are inspection‑ready and scalable.

Qualifications

• 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 spaces.
• Experience interfacing with regulatory agencies on facility approvals and inspections.

Responsabilités

• Lead end-to-end design, development, and construction of new pharmacy facilities, ensuring regulatory readiness.
• Manage design team selection and coordination (architects, MEP engineers, consultants) and oversee space planning for 503A/503B operations.
• Develop budgets, oversee value engineering, and coordinate with legal, operations, and regulatory bodies to obtain licenses and go-live.

Connaissances

Project management

Regulatory compliance

Pharmacy facility design

Stakeholder management

Construction oversight

Budgeting

Vendor management

Formation

Bachelor's degree in Architecture/Engineering/Pharmacy

Outils

Architectural drawings

Construction documents

Facility engineering specs

Description du poste

Headquarters: United States
URL: https://gilbertpharmaceuticals.com/

The Head of Design, Development, & Construction will own the entire end to end process of launching new compounding pharmacies nationally. This will include site selection, feasibility, budgeting, design team & contractor selection, project management, build-out, and regulatory readiness of all Gilbert Pharmaceuticals pharmacy facilities. Reporting to the Director of Pharmacy Development & Operations, this role bridges pharmacy operations expertise with construction, facilities engineering, and regulatory compliance to bring new pharmacy sites from concept through licensure and go-live. The ideal candidate has hands‑on experience designing and building efficient commercial spaces and pharmacy environments including traditional 503A compounding pharmacies and FDA‑registered 503B outsourcing facilities operating under current Good Manufacturing Practice (cGMP) Standards. Their thorough knowledge enables them to successfully navigate state and federal regulations required for pharmacy facility approval.

At Gilbert Pharmaceuticals , every role is AI-first. Work starts in an LLM to clarify intent and context, moves into the right tools to explore and execute, is tested with real users and stakeholders, and is continuously refined as we learn. AI and self‑serve research are default parts of how we work, not side experiments.

We are looking for people who take full ownership of their work, treat AI as a real collaborator, and care deeply about building a company that meaningfully improves how healthcare is delivered.

We’re Looking For

You think outside of the box, excel at creative problem‑solving, and are comfortable taking on projects that you have potentially never done before! You are a people‑person – empathetic, self‑aware, low ego, and extremely positive – and are comfortable working in a small collaborative team where you’ll wear many hats. You have care for performance, accessibility, and reliability as part of craft. You are passionate and proficient in written and verbal communication, and comfort pairing with designers, engineers, and marketers.

Key Responsibilities

Acquisition

• Lead market analysis and site selection to identify viable pharmacy locations nationally.
• Conduct feasibility assessments and due diligence on prospective sites, evaluating regulatory feasibility, build‑out complexity, and operational suitability.
• Develop and execute entitlement strategy for new pharmacy locations in coordination with legal and operations teams.
• Act as liaison between landlords, brokers, and Gilbert Pharmaceuticals on your prospective sites.
• Coordinate with internal stakeholders to supply landlords and brokers with essential company information to secure new leases and site acquisitions.

Entitlements

• Navigate land use and zoning requirements for each new pharmacy site.
• Lead master plan coordination and manage environmental compliance obligations across all facility projects.
• Oversee community outreach efforts and represent Gilbert Pharmaceuticals at public hearings as needed.
• Coordinate regulatory submissions and interface directly with operations team on state Boards of Pharmacy, DEA, FDA, and local authorities for facility inspections and approvals.
• Develop and maintain a facility compliance playbook for new site design and existing facility modifications.

Design

• Lead concept and programming strategy for all new pharmacy facilities, translating operational workflows into effective, compliant physical environments.
• Manage design team selection and coordination, including architects, MEP engineers, and specialty consultants.
• Lead the architectural design and space planning for new pharmacy locations, including compounding suites, sterile and non‑sterile areas, clean rooms, and dispensing environments.
• Develop detailed facility design standards and specifications aligned with USP , USP , USP , applicable state Board of Pharmacy requirements, and FDA cGMP requirements for 503B outsourcing facilities.
• Review and approve architectural drawings, construction documents, and engineering plans for all new pharmacy projects.
• Design scalable production environments for 503A and 503B operations, including batch manufacturing areas, quarantine/release zones, and controlled material flow segregation.
• Develop HVAC, cleanroom, airflow, and environmental monitoring specifications in coordination with engineering and operating partners.
• Coordinate with operating partners to ensure facility design supports validated processes, environmental monitoring programs, and batch production controls.

Pre-Con

• Develop project budgets and oversee value engineering exercises to optimize cost without compromising regulatory or operational standards.
• Lead GC selection processes, evaluating contractors for pharmacy build‑out experience, compliance track record, and execution capability.
• Manage permit management across all active projects, ensuring timely approvals from local building authorities and regulatory bodies.
• Develop and track project timelines, procurement schedules, and risk mitigation plans across multiple concurrent site developments.

Construction

• Serve as Owner’s representative throughout construction, maintaining accountability for design intent, budget, and schedule.
• Provide field oversight through regular site inspections and quality walkthroughs to ensure regulatory and operational standards are met.
• Maintain rigorous cost control across all active build‑outs, managing change orders and contractor performance.
• Oversee FF&E installation and commissioning of all pharmacy‑specific equipment and systems.
• Manage QA & closeout activities including installation qualifications of critical manufacturing utilities (e.g., WFI systems, clean steam, environmental monitoring) where applicable to 503A and 503B facilities.
• Drive operational readiness in partnership with pharmacy operations and quality teams, ensuring facilities are inspection‑ready as soon as possible.
• Maintain up‑to‑date documentation including as‑built drawings, equipment lists, and SOPs for all facility environments.
• Support evaluation of pharmacy partners by assessing the design and regulatory readiness of their existing facilities.

Requirements

• 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 , USP , USP , 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.

Preferred

• Licensed Architect (AIA), Professional Engineer (PE), or Certified Pharmaceutical Industry Professional (CPIP).
• Familiarity with digital health or telehealth‑linked pharmacy models.
• Strong vendor management experience working with contractors, engineers, and equipment suppliers.

What Success Looks Like (First 12 Months)

• Documented pharmacy facility design standards and a reusable build‑out playbook for new sites.
• Streamlined project flow to maximize efficiency and completion time per project.
• Documented budgets for all existing and prospective sites with cost efficient suggestions to scale nationally.
• Successful delivery of at least three to five new 503A pharmacy facilities on time, on budget, and licensed for operation.
• Successful delivery of at least one 503B pharmacy facility on time, on budget, and licensed for operation.
• All existing partner facilities assessed and documented against Gilbert’s compliance standards.
• Strong cross‑functional relationships established with pharmacy operations, contracting, and external vendor teams.

Benefits

Base salary, equity, and bonus structure are open to discussion based on experience and fit.