Production Manager
Bespoke Pharmaceuticals LLC
Job Description
Job Description
Supervisory Responsibility
Aseptic production supervisors, shift leads, operators, compounding technicians, filling line staff, and support personnel in classified cleanroom environments
Role Purpose
To lead and manage sterile injectable manufacturing operations, ensuring safe, compliant, and efficient aseptic processing in accordance with cGMP, regulatory requirements, and contamination control strategies.
Key Responsibilities
• Aseptic Production Operations
• Plan and execute sterile manufacturing activities including compounding, filtration, aseptic filling, lyophilization (if applicable), and packaging.
• Ensure all operations are performed in accordance with approved batch records, SOPs, and validated aseptic processes.
• Oversee cleanroom operations (ISO 5–8 environments), ensuring strict adherence to gowning, environmental controls, and aseptic techniques.
• Monitor production schedules and resolve operational issues to ensure uninterrupted manufacturing.
• Contamination Control & cGMP Compliance
• Ensure compliance with cGMP (21 CFR Parts 210/211), EU Annex 1, and other global regulatory standards for sterile products.
• Implement and maintain a robust Contamination Control Strategy (CCS) covering personnel, equipment, utilities, and environment.
• Oversee environmental monitoring (EM), cleanroom behavior, and aseptic practices to minimize contamination risks.
• Partner with QA to investigate deviations, sterility failures, and microbiological excursions, ensuring timely CAPA implementation.
• Aseptic Process Validation & Media Fills
• Lead and support aseptic process simulations (media fills) to demonstrate process sterility assurance.
• Support process validation (IQ/OQ/PQ), sterilization validation (autoclaves, dry heat, filtration), and cleaning validation.
• Ensure continued process verification and lifecycle management of sterile processes.
• Technology Transfer & Scale-Up
• Lead technology transfer of sterile products from R&D to commercial manufacturing.
• Ensure successful scale-up while maintaining sterility assurance and product quality.
• Collaborate with development and validation teams on process design and improvements.
• Equipment, Utilities & Facility Oversight
• Ensure proper operation and qualification of critical utilities (HVAC, HEPA filtration, WFI, clean steam, compressed gases).
• Oversee maintenance, calibration, and qualification of aseptic filling lines, isolators/RABS, and sterilization equipment.
• Collaborate with Engineering for equipment upgrades and troubleshooting.
• Team Leadership & Aseptic Training
• Lead, coach, and develop aseptic manufacturing teams, ensuring high performance and compliance.
• Ensure all personnel are trained and qualified in aseptic gowning, behavior, and cleanroom practices.
• Promote a strong culture of contamination control, quality, and safety.
• Cross-Functional Collaboration
• Work closely with QA, QC Microbiology, Validation, Engineering, and Regulatory Affairs teams.
• Coordinate with supply chain for availability of sterile components, filters, and raw materials.
• Support regulatory submissions and responses related to sterile manufacturing processes.
• Documentation & Data Integrity
• Ensure accurate and contemporaneous documentation in compliance with ALCOA+ principles.
• Review and approve batch records, environmental monitoring data, and deviation reports.
• Ensure compliance with electronic systems (MES/EBR) and data integrity requirements.
• Metrics, Trends & Reporting
• Monitor KPIs such as batch success rate, media fill success, EM trends, deviations, and right-first-time performance.
• Provide regular reports to leadership and implement improvements based on trend analysis.
Education/Training
• BS/MS in Pharmacy, Microbiology, Chemistry, Chemical Engineering, or related scientific discipline
Experience & Skills
• Minimum Experience: 10 years in sterile pharmaceutical manufacturing
• Preferred Experience: 15+ years in aseptic processing, injectable products, or biologics
• Strong expertise in aseptic processing, contamination control, and sterile manufacturing regulations
• In-depth knowledge of EU Annex 1, FDA aseptic guidance, and microbiological control
• Experience with media fills, sterilization processes, and cleanroom operations
• Familiarity with isolators, RABS, and advanced aseptic technologies
• Strong understanding of EM programs, utilities (WFI, HVAC), and microbiological risks
• Experience with deviation management, CAPA, and regulatory inspections
• Strong leadership, communication, and decision-making skills
Scope of Authority
Authority to manage sterile manufacturing operations, approve production activities, and ensure compliance with aseptic processing and cGMP requirements
GMP Readiness Responsibilities
Ensure aseptic manufacturing areas, personnel, utilities, and processes are continuously compliant and inspection-ready
Inspection Posture
Maintain a constant state of readiness for regulatory inspections (FDA, EMA, MHRA); ensure sterile operations and documentation meet the highest compliance standards
Growth Expectations
Demonstrate excellence in sterile operations, contamination control, and leadership to advance into Senior Production Manager, Aseptic Operations Head, or Site Leadership roles
- BS, MS or Ph.D.
- Minimum Experience:10 years
- Preferred Experience: 20 years
- Required Credentials: Chemistry, Biochemistry
- Required Training: Quality /Quality Control, Clinical studies, System Deployment, Regulatory Affairs, Auditing, Validation including system validation
- Interactions with Clients, Regulatory agencies (FDA EMA, PMDA, TGA HC, ICH)
- Product design, Drug development and commercialization.
- Metrics, KPIs and system development knowledge.
- ...themselves: to create the world's most advanced digital infrastructure that powers the progress of humanity. The Role: Production Manager As a Production Manager, you will lead daily production operations and oversee Infrastructure Build and Quality...SuggestedWork at officeRemote work
$80k - $90k
...Production Manager We're hiring a Production Manager to build and lead the production infrastructure behind ACQ Media and the personal brands of Alex Hormozi, Leila Hormozi, and Sharran Srivatsaa. This role is for someone who has managed full production pipelines at...SuggestedFull timeLocal areaRelocationFlexible hours3 days per week- ...We are seeking a highly motivated and results-driven Production Manager to lead a multi-shift operation consisting of 100+ employees. This role is responsible for driving planning, process improvement, productivity, and quality across all shifts while fostering a culture...SuggestedLocal areaRelocation packageAll shiftsFlexible hoursShift work
- ## Production ManagerApplylocations: Office - US, Las Vegas, NV 5620 Cameron Sttime type: Full timeposted on: Posted Todayjob requisition... ...THE JOB:** It is the primary responsibility of the Production Manager to supervise the production team and ensure that event...SuggestedWork at officeShift work
$90k - $115k
...hosts rotating through a single continuous broadcast, selling real product in real time. Think QVC, but DTC, digital-native, and moving at startup speed. We’re looking for a Live Studio Production Manager to own this operation end‑to‑end. The production setup is...SuggestedRelocation- Job Summary Primary responsibilities for the Production Manager are to coordinate and direct the daily activities in manufacturing, tracking material waste, and resolving quality issues across all shifts. Shift Supervisors will take daily direction from the Production...Local areaAll shiftsShift work
- ...Production Manager - Audio Visual Production - Las Vegas, NV Position Overview: The Production Manager is responsible for managing project scope for a multi-venue, full production, or high impact event(s) with support from Project Managers, Production System Engineers...Afternoon shift
$93.07k - $120.98k
...Production Manager The Production Manager is responsible for managing project scope for a multi-venue, full production, or high impact event(s) with support from Project Managers, Production System Engineers, and Technical Directors. This position will monitor progress...Work experience placementWorldwideAfternoon shift- ...essential to our business and delivering our mission. POSITION EXPECTATIONPOSITION EXPECTATIONS Position Summary The Production Manager in Training is responsible for learning all aspects of the Production Manager role. The Production Manager in Training...Work at office
- Overview MissionHires is hiring a hands‑on Senior Production Manager (Screen Printing) to lead end‑to‑end custom apparel production for a southwest‑based facility. The ideal candidate is a senior screen‑printing expert with 12+ years of technical experience and 8+ years...Flexible hoursShift work
$142.6k - $261.5k
...responsibilities Lead workstream delivery and ensure effective management of processes and solutions. Track deliverable completion and... ...Planning (ERP) and/or SAP S/4 HANA, particularly in the Production Planning (PP) module. A proven track record of leading teams...Summer holidayFlexible hours- MGM Resorts International is seeking a Production Manager in Las Vegas, NV. The successful candidate will supervise the production team and ensure events are executed on time and within budget. Responsibilities include managing staff, budgeting, and liaising with vendors...
- A leading event production company is seeking a Production Manager in Las Vegas, NV, responsible for managing project scope for multi-venue events. The role involves overseeing the execution of projects from design to post-show, ensuring client satisfaction and profitability...
- ## Vibee - Senior Production ManagerApplylocations: Las Vegas, NV, USAtime type: Full timeposted on: Posted 8 Days Agojob requisition id... ...the Sr. Director of Global Experiences. The Senior Production Manager role will be responsible for guiding the Production Operations...Seasonal workWork at officeLocal areaWeekend workAfternoon shift
- ...focused outcomes. With over 200 employees, a 350,000 sq. ft. production facility, and execution in more than 40 countries, ASTOUND is... ..., and collaboration. You are the bridge between Project Management and Production, ensuring that projects are properly planned, staged...
- ...Manufacturing Manager We are searching for an experienced Manufacturing Manager at our manufacturing facility in Las Vegas, NV... ...supervise and coordinate daily activities of approximately 15 production employees. Ensure safe, efficient operations while meeting quality...Shift work
- ...optimize manufacturing processes for maximum efficiency. Create production plans, schedules, and budgets to meet product demand while... ...excellence. Collaborate closely with the supply chain team to manage component procurement, inventory levels, and vendor...
- ...Position Overview We are seeking a highly motivated and experienced Roofing Production Manager to join our growing team! The Production Manager will be responsible for the overall support and direction of the production team and the safety program for their assigned...For contractorsFor subcontractorWork at office
- PEAK Technologies in Las Vegas is seeking a Project Manager to oversee events from concept to completion, collaborating with various teams to ensure seamless execution. Responsibilities include leading planning for Audio/Visual projects and managing budgets. The ideal candidate...
- ...SAP professional to join their Technical Consulting team specializing in Digital Manufacturing Cloud. In this dynamic role, you will manage complex initiatives, collaborate with clients, and lead workshops to enhance business operations. Successful candidates will have...Flexible hours
- ...JOB SUMMARY The production supervisor is responsible for the planning, scheduling and directing the work efforts of the production operations... ...the material handling area for both direct and indirect labor. Manage employee performance through motivation, delegation,...Local areaImmediate startShift workWeekend workAfternoon shift
- ...reconditioning company in Las Vegas is seeking a Reconditioning Manager to oversee daily operations at the Inspection Center. This... ...mentoring associates, maintaining safety standards, and planning production capacity. A valid driver's license and strong communication...
- FREEMAN is seeking an LED Manager, Operations to lead the pre-production LED design team responsible for operational planning and execution of LED projects. This includes supervision of resources, compliance with safety standards, and direct leadership over operational...
$142.6k - $261.5k
...responsibilities Lead workstream delivery and ensure effective management of processes and solutions. Track deliverable completion and... ...ERP and/or SAP S/4 HANA, with deep functional expertise in Production Planning (PP). Strong expertise in SAP PP configuration, master...Summer holidayWork at officeFlexible hours- JOB SUMMARY The production supervisor is responsible for the planning, scheduling and directing the work efforts of the production operations... ...material handling area for both direct and indirect labor. Manage employee performance through motivation, delegation,...Immediate startShift workWeekend workAfternoon shift
- ...of other discounts and perks. JOB SUMMARY Responsible for the management of all assigned project‑related wardrobe, costumes, walk‑... ...all tasks and/or assignments through all aspects of design and production from original concept through final installation. Liaison between...Seasonal workNight shiftWeekend workAfternoon shift
- World Wrestling Entertainment, Inc. seeks a Director of Production in Las Vegas, NV. The role involves leading all aspects of production... .... Candidates should possess at least 10 years in production management with relevant qualifications. The position demands effective communication...
- ...The Role Production Scheduler owns the day-to-day and week-to-week production schedule. This role turns demand and supply plans into... ...sequencing. Inventory & Material Planning Monitor and manage WIP and Finished Goods inventory to align with shipment...Work at officeLocal areaFlexible hoursShift work
- ...Production Scheduler Las Vegas, Nevada, United States The Role The Production Scheduler will be responsible for converting long... ...and enhance the overall supply chain strategy. Inventory Management Monitors WIP and FG inventory based on shipments...Work at officeShift work
- ...convenient. Solina is a fast‑growing business, with around 50 production sites and R&D laboratories present in more than 19 countries mainly... .... Communicates scheduling updates and changes to plant management, warehouse, and supply chain teams. Supports the operations team...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Production Manager. Be the first to apply!
- production manager food manufacturing Las Vegas, NV
- manufacturing manager Las Vegas, NV
- manufacturing production manager Las Vegas, NV
- director manufacturing science and technology Las Vegas, NV
- director external manufacturing Las Vegas, NV
- production planning manager Las Vegas, NV
- manufacturing operations manager Las Vegas, NV
- industrial production manager Las Vegas, NV
- production control manager Las Vegas, NV
- area production manager Las Vegas, NV


