{"id":126221,"date":"2026-05-18T15:31:49","date_gmt":"2026-05-18T15:31:49","guid":{"rendered":"https:\/\/bhsg.com\/jobs\/job\/lsnjn1459505aj_1779118309-production-manager-503b-outsourcing-facility-albany-new-york\/"},"modified":"2026-05-20T03:19:05","modified_gmt":"2026-05-20T03:19:05","slug":"lsnjn1459505aj_1779118309-production-manager-503b-outsourcing-facility-albany-new-york","status":"publish","type":"job_listing","link":"https:\/\/bhsg.com\/jobs\/job\/lsnjn1459505aj_1779118309-production-manager-503b-outsourcing-facility-albany-new-york\/","title":{"rendered":"Production Manager &#8211; 503B Outsourcing-Facility"},"content":{"rendered":"<h4><strong><a id=\"myCustomID\" href=\"https:\/\/jobs.beaconhillstaffing.com\/jobs\/job\/LSNJN1459505AJ_1779118309\">To Apply for this Job Click Here<\/a><\/strong><\/h4>\n<p>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.<\/p>\n<\/p>\n<p>They&#8217;re in need of a Production Manager to own day-to-day sterile production end-to-end &#8211; 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.<\/p>\n<\/p>\n<p>Because they&#8217;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&#8217;t written, troubleshoot what hasn&#8217;t been seen before, and stay on the floor.<\/p>\n<\/p>\n<p>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.<\/p>\n<p><strong> <\/strong><\/p>\n<p><strong>The Production Manager will have ownership over:<\/strong><\/p>\n<p><strong> <\/strong><\/p>\n<p><strong>**Production execution**<\/strong><\/p>\n<ul>\n<li>Direct day-to-day sterile manufacturing across formulation, aseptic fill, stoppering \/ sealing, and visual inspection<\/li>\n<li>Walk the production floor daily; confirm operations are in a state of control<\/li>\n<li>Own batch scheduling against the monthly capacity plan; protect on-time delivery<\/li>\n<li>Lead investigation and resolution of in-process deviations alongside QA<\/li>\n<li>Partner with the PIC and QA on batch record review, exception triage, and product release<\/li>\n<\/ul>\n<p><strong> <\/strong><\/p>\n<p><strong>**Process and equipment**<\/strong><\/p>\n<ul>\n<li>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)<\/li>\n<li>Drive transition from manual fill to semi-automated fill across all ten licensed SKUs<\/li>\n<li>Author and maintain Standard Operating Procedures, batch records, work instructions, and area logs<\/li>\n<li>Identify, propose, and implement continuous-improvement initiatives &#8211; cycle time, yield, scrap, changeover<\/li>\n<\/ul>\n<p><strong> <\/strong><\/p>\n<p><strong>**Compliance and inspection readiness**<\/strong><\/p>\n<ul>\n<li>Maintain the production area in a constant state of inspection readiness &#8211; NY State Board of Pharmacy and FDA<\/li>\n<li>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<\/li>\n<li>Lead production-side preparation and response for state inspections and FDA visits<\/li>\n<li>Own production CAPAs through closure with QA oversight<\/li>\n<\/ul>\n<p><strong> <\/strong><\/p>\n<p><strong>**Team and culture**<\/strong><\/p>\n<ul>\n<li>Hire, develop, schedule, and retain the production operator team across single shift today, transitioning to two-shift operations during the AST commissioning phase<\/li>\n<li>Set the safety, quality, and ownership tone on the floor &#8211; operators take their cues from this seat<\/li>\n<li>Train operators on aseptic technique, gowning, and cGMP documentation discipline<\/li>\n<li>Lead the daily production huddle and the weekly production-quality-operations review<\/li>\n<\/ul>\n<p><strong> <\/strong><\/p>\n<p><strong>**Leadership team contribution**<\/strong><\/p>\n<ul>\n<li>Represent production in weekly Leadership meetings<\/li>\n<li>Bring the floor&#8217;s voice to board updates, capital planning, and headcount planning<\/li>\n<li>Co-own the production-side inputs to monthly operations, capacity, and financial reviews<\/li>\n<\/ul>\n<p><strong> <\/strong><\/p>\n<p><strong>Requirements<\/strong><\/p>\n<ul>\n<li>**503B outsourcing-facility experience &#8211; 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.<\/li>\n<li>**cGMP manufacturing experience &#8211; 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<\/li>\n<li>Bachelor&#8217;s degree in chemistry, biology, pharmaceutical sciences, engineering, or related discipline (or equivalent direct experience)<\/li>\n<li>Minimum 5 years in pharmaceutical manufacturing, of which at least 3 years leading aseptic \/ sterile production teams<\/li>\n<li>Experience with aseptic fill \/ finish operations on PFS, vials, or cartridges<\/li>\n<li>Working knowledge of USP 797 and 800 for sterile compounding<\/li>\n<li>Track record managing supervisors and operators through deviations, CAPAs, change controls, and inspection responses<\/li>\n<li>Strong written and oral communication &#8211; you will write SOPs and brief the CEO and Board<\/li>\n<\/ul>\n<p><strong> <\/strong><\/p>\n<p><strong>Preferred qualifications<\/strong><\/p>\n<ul>\n<li>Direct experience with an AST GENiSYS C Cart, VSM-C, or comparable semi-automated PFS filling system<\/li>\n<li>Experience taking a 503B from pre-commercial to commercial scale, or commissioning a new fill line through IQ\/OQ\/PQ<\/li>\n<li>Familiarity with the licensed SKU set or analogous molecules (ketamine, lidocaine, glycopyrrolate, rocuronium, succinylcholine)<\/li>\n<li>PharmD or RPh with 503B production experience (would partner with our PIC on regulated activities)<\/li>\n<li>Six Sigma Green Belt or higher<\/li>\n<li>Familiarity with electronic batch records (DataNinja, MasterControl, or similar)\n<p><\/li>\n<\/ul>\n<p><img decoding=\"async\" src=\"https:\/\/counter.adcourier.com\/bGlmZXNjaWVuY2VzbmpuLjgwNDcyLjEyNTg0QGJlYWNvbmhpbGwuYXBsaXRyYWsuY29t.gif\"><\/p>\n<p><span style=\"color: #ffffff;\">LSNJN1459505AJ_1779118309<\/span><\/p>\n<h4><strong><a id=\"otherId\" href=\"https:\/\/jobs.beaconhillstaffing.com\/jobs\/job\/LSNJN1459505AJ_1779118309\">To Apply for this Job Click Here<\/a><\/strong><\/h4>\n","protected":false},"author":0,"featured_media":3770,"template":"","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","inline_featured_image":false,"_promoted":"","_job_location":"Albany, New York","_application":"lifesciencesnjn.80472.12584@beaconhill.aplitrak.com","_company_name":"Beacon Hill Staffing Group","_company_website":"","_company_tagline":"","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job-categories":[302,297,213,352],"job-types":[18,2],"class_list":{"0":"post-126221","1":"job_listing","2":"type-job_listing","3":"status-publish","4":"has-post-thumbnail","5":"hentry","7":"job-type-direct-permanent","8":"job-type-full-time"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Production Manager - 503B Outsourcing-Facility Albany New York<\/title>\n<meta name=\"description\" content=\"Production Manager - 503B Outsourcing-Facility Albany New York - Apply with Beacon Hill Staffing Services for this Production Manager - 503B Outsourcing-Facility job in Albany, New York\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/bhsg.com\/jobs\/job\/lsnjn1459505aj_1779118309-production-manager-503b-outsourcing-facility-albany-new-york\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Production Manager - 503B Outsourcing-Facility Albany New York\" \/>\n<meta property=\"og:description\" content=\"Production Manager - 503B Outsourcing-Facility Albany New York - Apply with Beacon Hill Staffing Services for this Production Manager - 503B Outsourcing-Facility job in Albany, New York\" \/>\n<meta property=\"og:url\" content=\"https:\/\/bhsg.com\/jobs\/job\/lsnjn1459505aj_1779118309-production-manager-503b-outsourcing-facility-albany-new-york\/\" \/>\n<meta property=\"og:site_name\" content=\"Nationwide Staffing Agency | Temp &amp; 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