Production Manager
Job Description
Production Manager (503B Sterile Manufacturing)
Location: Albany, NY (On-site)
Position Type: Full-time, Exempt
Reporting to: Chief Executive Officer
About the Opportunity
Rx relief has partnered with a fast-growing, venture-backed 503B outsourcing facility in the Albany area to find a visionary manufacturing leader. Our client commercializes a critical portfolio of sterile pre-filled syringes (PFS) and is building a modern, digital-first production environment.
As the Production Manager, you will hold a vital seat on the leadership team, directly owning day-to-end sterile manufacturing operations. This is a highly visible, hands-on role. Instead of navigating layers of corporate bureaucracy, you will establish production cadences, spearhead automation transitions, and directly influence the company’s technological roadmap.
Non-Negotiable Requirements
To be considered for this role, candidates must decisively clear two specific benchmarks:
True 503B Outsourcing Experience: You must have direct, hands-on production experience inside an FDA-registered 503B compounding facility. Traditional 503A retail compounding, traditional hospital pharmacy, or non-FDA-registered manufacturing environments will not qualify.
Expert cGMP Working Command: You possess a deep, practical understanding of 21 CFR Parts 210 and 211. Authoring deviations, managing CAPAs, and confidently defending batch records in front of regulatory inspectors must be second nature to you.
What You Will Own
Production Execution: Direct daily operations across compounding, formulation, aseptic filling, sealing, and visual inspection. Maintain an active presence on the cleanroom floor to ensure all operations remain in a strict state of control.
Automation & Process Evolution: Co-lead the commissioning, validation (IQ/OQ/PQ), and daily operation of advanced semi-automated filling lines. Guide the facility's transition from manual fills to automated PFS systems.
Compliance & Audit Readiness: Keep the production environment in a constant state of inspection readiness for the FDA and State Board of Pharmacy. Ensure total alignment with USP <797>, USP <800>, and current 503B draft guidances.
Team Development: Recruit, mentor, and schedule a dedicated team of compounding technicians and operators. Lead the floor through a transition from a single shift to a two-shift operational model during upcoming equipment expansions.
Executive Leadership: Represent the production ecosystem in weekly leadership meetings, contributing the floor's voice to capital planning, headcount forecasting, and capacity reviews.
Qualifications & Background
Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or a related scientific discipline (equivalent direct manufacturing experience will be considered).
A minimum of 5 years in pharmaceutical manufacturing, with at least 3 years specifically leading teams in aseptic/sterile fill-finish environments.
Proven experience handling pre-filled syringes (PFS), vials, or cartridges.
Superb technical writing abilities; capable of drafting airtight SOPs, deviations, and operational summaries for the Board and executive team.
Preferred Assets: Direct experience with semi-automated PFS filling carts (such as AST systems), a track record of scaling a 503B from pre-commercial to commercial scale, or a PharmD/RPh designation.
Compensation & Benefits
Base Salary: $135,000 - $165,000, including a yearly bonusRelocation: Relocation assistance available for the right candidate
Compensation / Pay Rate (Up to): $135,000.00 - $165,000.00 Per Year