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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 503
B 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 c
GMP 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 , USP
, 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 bonus
Relocation:
Relocation assistance available for the right candidate Compensation / Pay Rate (Up to): $135,000.00 - $165,000.00 Per Year
