Production Manager – 503B Outsourcing-Facility

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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). This position reports directly to the CEO.

They’re in need of 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 growing 503B.

Because they’re in early stages, 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.

They run DataNinja eBR, NetSuite, MasterControl, and OceanView, and actively deploying AI-augmented exception triage and inspection-readiness tooling. The Production Manager will help shape that roadmap, not just operate inside it.

The Production Manager will have ownership over:

**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. We are not equating 503A retail compounding, hospital pharmacy, or non-FDA-registered operations to 503B for this role.
• **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
• 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)

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