Job Title

Job DescriptionCoreFactor is searching for a Chief Pharmacist for a Pharmaceutical Manufacturer in Albany, NY, on a permanent/full-time basis. ABOUT THE FACILITYOur 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 RESPONSIBILITIESServe as Pharmacist-in-Charge under New York State Education Law §6808 and 8 NYCRR Part 63Perform 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 architectureOwn contemporaneous, inspection-ready batch record documentation and real-time contamination control sign-offsExecute and supervise viable and non-viable environmental monitoring; lead trend review and excursion investigations with root cause analysis and CAPA inputsPartner with QA under defined separation of authority - support deviation reporting while respecting QA-only disposition and release responsibilitiesOversee outsourced laboratory governance - ensure results are received, controlled, traceable, and incorporated into release documentationManage controlled substance access, vault/safe controls, chain-of-custody, and pharmacist presence requirementsLead pre-production validation activities: smoke studies, media fills, cleaning validation, and personnel qualificationTrain and supervise compounding technicians in aseptic technique, documentation discipline, and inspection-ready conductMaintain compliance with FDA cGMP (21 CFR 210/211), 21 CFR Part 11, DEA controlled substance requirements (21 CFR 1301.72), and USP , , RequirementsActive New York State pharmacist license (or ability to obtain promptly); eligible for PIC designationHands-on sterile compounding experience in a 503B outsourcing facility, 503A pharmacy, or cGMP sterile manufacturing environmentDirect experience with aseptic processing, sterilizing filtration, and cleanroom gowning/behavior protocolsStrong cGMP documentation discipline - comfortable working within electronic QMS workflows and digital batch recordsAbility to provide on-site pharmacist coverage during all compounding operationsPREFERRED QUALIFICATIONSPrior 503B outsourcing facility or FDA-inspected environment experiencePrior PIC or PIC-designate experienceExperience with outsourced QC lab governance and quality agreementsFamiliarity with MasterControl (eQMS), MES platforms, or equivalent digital production systemsStartup or build-to-compliance experience in a sterile compounding environment