Production Manager - 503B Outsourcing-Facility

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 inspectionWalk the production floor daily; confirm operations are in a state of controlOwn batch scheduling against the monthly capacity plan; protect on-time deliveryLead investigation and resolution of in-process deviations alongside QAPartner 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 SKUsAuthor and maintain Standard Operating Procedures, batch records, work instructions, and area logsIdentify, 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 FDAEnsure full compliance with cGMP (21 CFR Parts 210 and 211), USP 797 and 800, and applicable FDA guidance for outsourcing facilities under section 503BLead production-side preparation and response for state inspections and FDA visitsOwn 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 phaseSet the safety, quality, and ownership tone on the floor - operators take their cues from this seatTrain operators on aseptic technique, gowning, and cGMP documentation disciplineLead the daily production huddle and the weekly production-quality-operations review **Leadership team contribution**Represent production in weekly Leadership meetingsBring the floor's voice to board updates, capital planning, and headcount planningCo-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 inspectorBachelor'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 teamsExperience with aseptic fill / finish operations on PFS, vials, or cartridgesWorking knowledge of USP 797 and 800 for sterile compoundingTrack record managing supervisors and operators through deviations, CAPAs, change controls, and inspection responsesStrong written and oral communication - you will write SOPs and brief the CEO and Board Preferred qualificationsDirect experience with an AST GENiSYS C Cart, VSM-C, or comparable semi-automated PFS filling systemExperience taking a 503B from pre-commercial to commercial scale, or commissioning a new fill line through IQ/OQ/PQFamiliarity 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 higherFamiliarity with electronic batch records (DataNinja, MasterControl, or similar)Beacon Hill is an equal opportunity employer and individuals with disabilities and/or protected veterans are encouraged to apply.California residents: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.Company Profile:Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.Learn more about Beacon Hill and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.bhsg.com.Benefits Information:Beacon Hill offers a robust benefit package including, but not limited to, medical, dental, vision, and federal and state leave programs as required by applicable agency regulations to those that meet eligibility. Upon successfully being hired, details will be provided related to our benefit offerings.We look forward to working with you!Beacon Hill. Employing the Future™