Asepsis, Biology, Biotech and Pharmaceutical, C Programming Language, Cadence, Capacity Management, Change Control, Chemistry, Code of Federal Regulations, Commissioning, Current Good Manufacturing Practice (cGMP), Documentation, Drug Manufacturing, FDA (Food and Drug Administration), Identify Issues, Leadership, Maintain Compliance, Manufacturing, Operational Audit, Outsourcing, Pharmacy, Presentation/Verbal Skills, Process Validation, Production Management, Quality Assurance, Safety/Work Safety, Schedule Development, Six Sigma Green Belt, Standard Operating Procedures (SOP), Stock Keeping Unit (SKU), Time Management, Writing Skills
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).
We are hiring a Production Manager to own day-to-day sterile production end-to-end — from material release through aseptic fill, visual inspection, and final release handoff to QA. This is a hands-on leadership role at a young 503B.
Because we are early, the Production Manager will operate as a senior operating leader, not as a layer in a 100-person factory. You will set up the production cadence, write what isn't written, troubleshoot what hasn't been seen before, and stay on the floor.
What You Will Own:
Production execution
Direct day-to-day sterile manufacturing across formulation, aseptic fill, stoppering / sealing, and visual inspection
Walk the production floor daily; confirm operations are in a state of control
Own batch scheduling against the monthly capacity plan; protect on-time delivery
Lead investigation and resolution of in-process deviations alongside QA
Partner with the PIC and QA on batch record review, exception triage, and product release
Process and equipment
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.
Demonstrable working command of 21 CFR Parts 210 and 211. You can write a deviation, run a CAPA, defend a batch record in front of an inspector.
Plus:
Bachelor's degree in chemistry, biology, pharmaceutical sciences, engineering, or related discipline (or equivalent direct experience)
Minimum 5 years in pharmaceutical manufacturing, of which at least 3 years leading aseptic / sterile production teams
Experience with aseptic fill / finish operations on PFS, vials, or cartridges
Working knowledge of USP <797> and <800> for sterile compounding
Track record managing supervisors and operators through deviations, CAPAs, change controls, and inspection responses
Strong written and oral communication — you will write SOPs and brief the CEO and Board
Preferred qualifications
Direct experience with an AST GENiSYS C Cart, VSM-C, or comparable semi-automated PFS filling system
Experience taking a 503B from pre-commercial to commercial scale, or commissioning a new fill line through IQ/OQ/PQ
Familiarity with the licensed SKU set or analogous molecules (ketamine, lidocaine, glycopyrrolate, rocuronium, succinylcholine)
PharmD or RPh with 503B production experience (would partner with our PIC on regulated activities)
Six Sigma Green Belt or higher
Familiarity with electronic batch records (DataNinja, MasterControl, or similar)