Chief Pharmacist (Permanent)

CoreFactor is searching for a Chief Pharmacist for a Pharmaceutical Manufacturer in Albany, NY, on a permanent/full-time basis. 

ABOUT THE FACILITY

Our client is an FDA-registered 503B outsourcing facility preparing to commence commercial sterile compounding operations. The facility features two ISO-classified sterile cleanroom suites, an electronic QMS/MES/ERP stack, and outsourced QC testing. Products are high-risk sterile preparations (aqueous solutions from bulk APIs via sterilizing filtration and aseptic fill).

KEY RESPONSIBILITIES

• Serve as Pharmacist-in-Charge under New York State Education Law §6808 and 8 NYCRR Part 63
  
• Perform and oversee high-risk sterile compounding: API dissolution, pH adjustment, sterilizing filtration (0.2 µm), and aseptic filling under ISO 5 / ISO 7 / ISO 8 room architecture
  
• Own contemporaneous, inspection-ready batch record documentation and real-time contamination control sign-offs
  
• Execute and supervise viable and non-viable environmental monitoring; lead trend review and excursion investigations with root cause analysis and CAPA inputs
  
• Partner with QA under defined separation of authority — support deviation reporting while respecting QA-only disposition and release responsibilities
  
• Oversee outsourced laboratory governance — ensure results are received, controlled, traceable, and incorporated into release documentation
  
• Manage controlled substance access, vault/safe controls, chain-of-custody, and pharmacist presence requirements
  
• Lead pre-production validation activities: smoke studies, media fills, cleaning validation, and personnel qualification
  
• Train and supervise compounding technicians in aseptic technique, documentation discipline, and inspection-ready conduct
  
• Maintain compliance with FDA cGMP (21 CFR 210/211), 21 CFR Part 11, DEA controlled substance requirements (21 CFR 1301.72), and USP <795>, <797>, <800>
   

Requirements

• Active New York State pharmacist license (or ability to obtain promptly); eligible for PIC designation
  
• Hands-on sterile compounding experience in a 503B outsourcing facility, 503A pharmacy, or cGMP sterile manufacturing environment
  
• Direct experience with aseptic processing, sterilizing filtration, and cleanroom gowning/behavior protocols
  
• Strong cGMP documentation discipline — comfortable working within electronic QMS workflows and digital batch records
  
• Ability to provide on-site pharmacist coverage during all compounding operations
   
  

PREFERRED QUALIFICATIONS

• Prior 503B outsourcing facility or FDA-inspected environment experience
  
• Prior PIC or PIC-designate experience
  
• Experience with outsourced QC lab governance and quality agreements
  
• Familiarity with MasterControl (eQMS), MES platforms, or equivalent digital production systems
  
• Startup or build-to-compliance experience in a sterile compounding environment