Head of Design & Development & Construction

NEPSE Trading; United States; On-site; USD 180,000 - 260,000; Full time

Job summary

Gilbert Pharmaceuticals seeks a Head of Design, Development & Construction to own the full lifecycle from site selection to licensure and go-live for national pharmacy facilities.

You will bridge pharmacy operations with construction, facilities engineering, and regulatory compliance, ensuring cGMP standards for 503A and 503B environments. AI-first collaboration and aggressive problem solving are valued.

Qualifications

• Extensive experience launching pharmacy facilities with regulatory input.
• Strong knowledge of 503A/503B operations and FDA regulations.
• Proven ability to manage budgets, schedules, and teams.
• Experience coordinating architects, engineers, and contractors.

Responsibilities

• Own end-to-end design, development, and construction of new pharmacy sites nationwide.
• Lead entitlement, permitting, and regulatory submissions with external partners.
• Oversee design standards for production areas, clean rooms, and dispensing spaces.
• Direct project budgets, timelines, and contractor performance across multiple sites.

Skills

Project management

Budgeting

Regulatory compliance

Facilities engineering

Construction management

Cross-functional leadership

Job description

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

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 insp