Head of Design & Development & Construction

About the Role

Gilbert Pharmaceuticals is seeking a Head of Design, Development, & Construction to oversee the complete lifecycle of launching new compounding pharmacies nationwide. This pivotal role involves managing everything from initial site selection and feasibility studies to budgeting, selecting design and construction teams, project management, facility build-out, and ensuring regulatory compliance for all new pharmacy facilities. Reporting to the Director of Pharmacy Development & Operations, this position requires a blend of expertise in pharmacy operations, construction, facilities engineering, and regulatory adherence to guide new pharmacy sites from conception through to licensure and operational launch. The ideal candidate will possess practical experience in designing and constructing efficient commercial and specialized pharmacy environments, including both traditional 503A compounding pharmacies and FDA-registered 503B outsourcing facilities that adhere to current Good Manufacturing Practice (cGMP) standards. A deep understanding of state and federal regulations pertinent to pharmacy facility approval is essential.

This role embraces an AI-first approach, utilizing Large Language Models (LLMs) for initial clarification and context, followed by the application of appropriate tools for execution and testing with users. Continuous refinement based on feedback and learning is a core aspect of this methodology. We are looking for individuals who take full ownership, view AI as a genuine collaborator, and are committed to enhancing healthcare delivery.

Key Responsibilities

• Acquisition: Spearhead market analysis and site selection for potential pharmacy locations across the country. Conduct thorough feasibility assessments and due diligence, evaluating regulatory viability, construction complexity, and operational suitability of prospective sites. Develop and implement entitlement strategies in collaboration with legal and operations teams. Serve as the primary liaison between landlords, brokers, and Gilbert Pharmaceuticals for site-related matters. Coordinate with internal departments to provide necessary company information to landlords and brokers for lease and site acquisition.
• Entitlements: Navigate land use and zoning regulations for each new pharmacy site. Lead master plan coordination and manage environmental compliance for all facility projects. Oversee community engagement and represent the company at public hearings when required. Coordinate regulatory submissions and liaise directly with the operations team and relevant authorities (State Boards of Pharmacy, DEA, FDA) for facility inspections and approvals. Establish and maintain a comprehensive facility compliance playbook for new site designs and modifications to existing facilities.
• Design: Direct the strategy for concept and programming for all new pharmacy facilities, translating operational workflows into efficient and compliant physical spaces. Manage the selection and coordination of the design team, including architects, MEP engineers, and specialized consultants. Lead the architectural design and space planning for new pharmacy locations, encompassing compounding suites, sterile and non-sterile areas, clean rooms, and dispensing environments. Develop detailed facility design standards and specifications in alignment with USP <797>, USP <800>, relevant state Board of Pharmacy regulations, 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, ensuring proper segregation of materials and workflow. Develop specifications for HVAC, cleanroom, airflow, and environmental monitoring in conjunction with engineering and operational partners. Ensure facility designs support validated processes, environmental monitoring, and batch production controls in collaboration with operating partners.
• Pre-Construction: Develop project budgets and conduct value engineering to optimize costs while maintaining regulatory and operational standards. Lead the selection process for General Contractors (GCs), assessing their experience in pharmacy build-outs, compliance history, and execution capabilities. Manage permit acquisition for all active projects, ensuring timely approvals from local building authorities and regulatory bodies. Develop and monitor project timelines, procurement schedules, and risk mitigation plans for multiple concurrent site developments.
• Construction: Act as the Owner's representative throughout the construction phase, ensuring adherence to design intent, budget, and schedule. Provide on-site oversight through regular inspections and quality checks to confirm compliance with regulatory and operational standards. Maintain strict cost control over all active build-outs, managing change orders and contractor performance. Oversee the installation and commissioning of all pharmacy-specific equipment and systems. Manage Quality Assurance (QA) and closeout activities, including installation qualifications for critical manufacturing utilities where applicable. Drive operational readiness in partnership with pharmacy operations and quality teams to ensure facilities are inspection-ready promptly. Maintain updated documentation, including as-built drawings, equipment inventories, and Standard Operating Procedures (SOPs) for all facility environments. Support the evaluation of potential pharmacy partners by assessing the design and regulatory readiness of their existing facilities.

What Success Looks Like (First 12 Months)

• Establish documented pharmacy facility design standards and a repeatable build-out playbook for new sites.
• Implement streamlined project workflows to enhance efficiency and reduce project completion times.
• Develop documented budgets for all current and prospective sites, including cost-saving recommendations for national scaling.
• Successfully deliver three to five new 503A pharmacy facilities on schedule, within budget, and licensed for operation.
• Successfully deliver at least one new 503B pharmacy facility on schedule, within budget, and licensed for operation.
• Assess and document all existing partner facilities against Gilbert Pharmaceuticals' compliance standards.
• Build strong collaborative relationships with pharmacy operations, contracting, and external vendor teams.

Additional Information

This role requires travel to pharmacy sites for construction oversight, inspections, and go-live support.