Pharmacist-in-Charge (PIC)-Sterile Compounding

Job Description

ABOUT US

Galaxy Pharmaceuticals, LLC is an FDA-registered 503B outsourcing facility in Albany, NY manufacturing sterile compounded preparations for hospitals, health systems, and clinics. Our facility features two ISO-classified sterile cleanroom suites with digital-first production documentation, barcode-driven traceability, and a formalized quality management system exceeding cGMP expectation. We are completing final validation and qualification activities before commencing commercial production of sterile solutions compounded from bulk APIs via sterilizing filtration and aseptic fill.

POSITION SUMMARY

The PIC is the senior pharmacy professional with statutory accountability under New York State law for all sterile compounding operations, regulatory compliance, and pharmaceutical oversight. This is a hands-on leadership role: the PIC personally executes and supervises high-risk aseptic processing while owning documentation governance, contamination control programs, controlled substance compliance, personnel training, and inspection readiness. The PIC serves as the primary regulatory contact during FDA, State Board of Pharmacy, and DEA inspections.

This is a launch-phase position with significant regulatory visibility. Success requires deep cGMP expertise, high documentation rigor, contamination control ownership, and calm, precise execution under inspection-style scrutiny.

KEY RESPONSIBILITIES

Sterile Compounding and Aseptic Operations

• Oversee and personally perform high-risk sterile compounding: API dissolution, pH adjustment, sterilizing filtration (0.2 µm), and aseptic filling under ISO 5 within ISO 7/8 cleanroom architecture

• Lead media fill/process simulation programs; ensure all personnel maintain current aseptic qualification

• Enforce line clearance, unidirectional flow, and contamination control protocols

Regulatory Compliance and Statutory PIC Accountability

• Serve as designated PIC under NYS Education Law §6808; bear personal professional responsibility for all pharmacy operations

• Maintain compliance with FDA cGMP (21 CFR 210/211), 503B guidance, USP <797>/<795>/<800>, 21 CFR Part 11, and DEA regulations

• Lead FDA inspections, State BOP audits, and DEA inspections; manage front-room/back-room response and post-inspection remediation

• Maintain all facility licenses and registrations (FDA, DEA, state pharmacy) and regulatory reporting obligations

Environmental Monitoring and Contamination Control

• Own the facility contamination control strategy; oversee viable/non-viable EM programs, daily data review, trend analysis, and excursion investigations

• Oversee cleanroom certification, HEPA integrity testing, smoke study validation, and cleaning/disinfection program validation

Documentation Governance and Data Integrity

• Establish ALCOA+ documentation culture; review and approve batch records; enforce real-time electronic documentation with zero tolerance for backfilling

• Oversee audit trail reviews for 21 CFR Part 11 compliance; govern outsourced QC lab data integration into release documentation

Quality System Partnership

• Collaborate with QA under defined separation of authority (QA retains sole disposition authority); provide production-side facts for deviations, CAPA, and change control

• Contribute to APQRs, process validation, supplier qualification, and management review

Controlled Substance Program

• Manage CS operations per DEA 21 CFR 1301.72: vault/safe access, chain-of-custody, reconciliations, and reporting; investigate discrepancies immediately

• Enforce pharmacist presence requirements and facility closure protocols when coverage unavailable

Personnel Training and Development

• Design and manage training programs: aseptic technique, gowning qualification, media fill participation, GDP, and role-based SOP curricula

• Conduct competency assessments; train and mentor technicians and operators; build succession depth

Pre-Production Validation and Launch Readiness

• Lead remaining readiness activities: smoke studies, media fills, cleaning validation, CSV user testing, equipment qualification, and SOP finalization

• Present production commencement readiness assessment to executive leadership

REQUIRED QUALIFICATIONS

• Pharm.D. or equivalent; active, unrestricted New York State pharmacist license with PIC eligibility per NYS Education Law §6808

• 5+ years sterile compounding experience in 503A, 503B, or cGMP sterile manufacturing with hands-on aseptic processing and sterilizing filtration

• Deep knowledge of FDA cGMP (21 CFR 210/211), USP <797>/<795>/<800>, 21 CFR Part 11, and DEA controlled substance regulations

• Strong cGMP documentation discipline (ALCOA+ principles) and experience with electronic QMS/MES workflows

• Demonstrated team leadership, training program management, and inspection readiness experience

• Ability to work on-site in cleanroom environments with full sterile gowning for extended periods

PREFERRED QUALIFICATIONS

• Prior PIC designation; 503B outsourcing facility experience; FDA inspection response leadership

• Startup/build-to-compliance experience; BPS Board Certified Sterile Compounding Pharmacist (BCSCP)

• Experience with eQMS/MES/LIMS platforms, computer system validation, and outsourced QC lab governance

• Experience designing contamination control strategies, EM trending programs, and media fill protocols

COMPENSATION AND BENEFITS

• Competitive salary commensurate with experience; performance-based annual bonus

• Medical, dental, and vision insurance; 401(k) with company match

• Generous PTO, paid holidays, CE reimbursement, and licensure fee reimbursement

• Life/disability insurance, relocation assistance, and sign-on bonus (if applicable)

• Conference attendance support and professional organization membership