Director of Pharmacy / Pharmacist-in-Charge
About The Position
The Director of Pharmacy, Pharmacist-in-Charge (PIC) leads multistate licensing, FDA and DEA compliance, regulatory inspections, and R&D support at a Texas-based 503B outsourcing facility. The role reports directly to the CEO and owns licensing and regulatory strategy to support expansion from a multistate footprint to a national presence by the end of 2027. The facility supplies hard-to-source specialty medications to hospitals, health systems, clinics, infusion centers, and pharmacies. This is an onsite, initially individual-contributor leadership role partnering with Quality and Operations, without oversight of manufacturing. The position offers the opportunity to shape licensing strategy, support market entry and sales growth, and build a team as the company grows. Compensation includes a competitive base salary plus a performance-based bonus. Remote and hybrid work are not available.
Requirements
- PharmD or bachelor's degree in pharmacy.
- At least five years of sterile pharmaceutical manufacturing experience under cGMP at a 503B outsourcing facility or traditional pharmaceutical manufacturer; compounding-only experience does not qualify.
- At least three years of management experience and ability to lead cross-functional work without direct reports.
- Active pharmacist license in good standing.
- Willingness to obtain additional state pharmacist licenses.
- Working knowledge of FDA, DEA, state board of pharmacy, cGMP, and 503B regulatory requirements.
- Strong communication, organization, regulatory documentation, and problem-solving skills.
- Familiarity with electronic batch records and inventory management systems.
- Ability to work fully gowned, including wearing a respirator, in production labs for extended periods.
Nice To Haves
- Pharmacist licenses in multiple states.
- Formulation development experience.
- Prior Pharmacist-in-Charge experience across a multistate license footprint.
- Experience leading regulatory inspections and writing responses to FDA 483s or board observations.
Responsibilities
- Serve as Pharmacist-in-Charge and ensure federal and state regulatory and licensing compliance.
- Drive multistate licensing strategy, including applications, renewals, nonresident registrations, reporting, and maintenance, avoiding lapses that delay market entry.
- Oversee FDA and DEA compliance and own semiannual FDA product reporting.
- Lead state regulatory inspections and inspection readiness; coordinate responses to observations, deficiencies, and corrective actions with Quality.
- Support sterile and nonsterile R&D, including formulation, clinical rationale, documentation, and manufacturability.
- Partner with Operations and Quality on specifications and process controls.
- Support executive leadership on strategic initiatives and occasionally travel to industry events.
Benefits
- Performance-based bonus
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
