Production Manager (Full -Time/Permanent)

CoreFactor is searching for Sterile Compounding Production Manager on a permanent/full-time basis for a client located in Albany, NY. 

Our client is a 503B outsourcing facility commercializing a portfolio of ten sterile pre-filled syringe SKUs across five molecules (Ketamine, Lidocaine, Glycopyrrolate, Rocuronium, Succinylcholine).

Co-lead commissioning, IQ/OQ/PQ, and routine operation of the AST GENiSYS C Cart, VSM-C, and Laminar Airflow Hood (Double Wide Extended configuration)
Drive transition from manual fill to semi-automated fill across all ten licensed SKUs
Author and maintain Standard Operating Procedures, batch records, work instructions, and area logs
Identify, propose, and implement continuous-improvement initiatives — cycle time, yield, scrap, changeover

Compliance and inspection readiness

Maintain the production area in a constant state of inspection readiness — NY State Board of Pharmacy and FDA
Ensure full compliance with cGMP (21 CFR Parts 210 and 211), USP <797> and <800>, and applicable FDA guidance for outsourcing facilities under section 503B
Lead production-side preparation and response for state inspections and FDA visits
Own production CAPAs through closure with QA oversight

Team and culture
Hire, develop, schedule, and retain the production operator team across single shift today, transitioning to two-shift operations during the AST commissioning phase
Set the safety, quality, and ownership tone on the floor — operators take their cues from this seat
Train operators on aseptic technique, gowning, and cGMP documentation discipline
Lead the daily production huddle and the weekly production-quality-operations review

Leadership team contribution
Represent production in weekly Leadership meetings
Bring the floor's voice to board updates, capital planning, and headcount planning
Co-own the production-side inputs to monthly operations, capacity, and financial reviews

Requirements

503B outsourcing-facility experience — required.

Direct hands-on production experience inside an FDA-registered 503B compounding outsourcing facility. 
cGMP manufacturing experience — required.