• Oversee the issuance of materials and ensure lot traceability and certification.
• Implement, train, and maintain procedures for all applicable production areas.
• Help formulate a contingency plan during interruption of Net-server shutdown.
• Assist Engineering in panel layout, stack-up, scaling, and other issues pertaining to the issuance of shop travelers.
• Assist the Quality department in the disposition of product, and assign appropriate defect analysis and corrective action.
• Verify compliance with Periodic Maintenance schedules.
• Schedule departments effectively, including overtime 
• Direct shift supervisors concerning inventories, scheduling strategy, unique or unusual process situations, etc.
• Reconcile and update the inventory module and create an accurate month-end report.
• Fill in during Production Control Supervisor’s absence.
• Interviewing and hiring of all prospective employees.
• Reviewing of personnel performance and wage requirements.
• Discipline of personnel including termination
• Ensure stakeholders’ quality requirements are understood and met, grow, oversee
• Track the effectiveness of quality databases, applications, and systems. 
• Lead the development of quality assurance roadmap, systems, and plans designed to improve the organization’s overall effectiveness and the quality of products coming from manufacturing partners. 

Skills: Material Issuance and Traceability, Procedure Implementation, Contingency Planning, Engineering Support, Product Disposition, Compliance Verification, Scheduling Management, Inventory Reconciliation

• Responsible for the overall management of pharmaceutical liquid and tablet manufacturing and packaging operations in a state-of-the-art facility ensuring regulatory compliance in a GMP environment.
• Focus includes workforce management and development, production metrics and attainment, work process and material flows and efficiencies, cost and quality improvement.
• Operations are transitioning to a new state-of-the-art OTC drug manufacturing facility.
• Opportunity to lead a well-established workforce through change and growth at a pivotal time of facility start-up, ramp-up and attainment.
• Use of lean/six-sigma principles are encouraged. 
• Safety and quality are paramount.
• Management of Tableting and Packaging Departments in a new state-of-the-art manufacturing facility.
• Producing Finished Pharmaceutical Goods with a focus on quality, regulatory compliance, cycle time, Cost of Goods Sold and safety in support of increasing demand.
• Provides operational leadership to the manufacturing team ensuring the work environment meets or exceeds safety, quality and industry standards.
• Plans, implements and maintains manufacturing processes for new or existing products.
• Develops and executes production plans and schedules delivering business objectives
• Professionally develops supervisors and staff through mentoring, coaching and training via development and training plans.
• Leads efforts to determine and implement the most cost-effective equipment and processes in a GMP compliant powder, tablet and liquid production environment resulting in increased quality, productivity, regulatory compliance, efficiency and effective management of human capital.
• Support capital projects associated with the selection and installation of manufacturing and packaging equipment and facility-related GMP critical systems.
• Identify opportunities for improvement including labor productivity, set-up and changeover times, cycle time, etc.
• Study and rearrange material flow and operations sequence.
• Design, document and control layouts for facilities, lines and workstations.

Skills: Pharmaceutical Operations Management, Workforce Management, Lean Six Sigma, Safety and Quality Compliance, Manufacturing Process Development, Production Planning, Staff Development, Capital Project Support

• Staffing, training, performance and compliance of department and personnel.
• Ensures staff and facility are always regulatory inspections ready.
• Assists in the development of department production and quality goals.
• Manages production output with labor efficiencies while meeting safety and quality levels.
• Develop manufacturing methods and machine routings in ERP.
• Schedules production activities and provides timelines and delivery dates as well as tracking and updates of all activities.
• Responsible for performance management of all direct reports as well as provide oversight and guidance to supervisors.
• Leads and manages continuous improvement processes.
• Collaborate with Director of Human Resources to develop, support and grow staff including assessment of full-time and temporary staffing needs to achieve company and personal growth goals.
• Utilizes manpower, facilities, equipment, materials, and assets to ensure minimal manufacturing errors.
• On-Call 24 hours a day and the ability to work weekends as required, plus provide a strong presence across all three shifts with a focus on continuous learning and growth of staff.
• Analyzes new processes and equipment with the intent of achieving continuous improvement of present methods. 
• Facilitates educates and partners with cross-functional groups to lead a culture of continuous improvement efforts.
• Implement 5S and lean/six-sigma process improvement methodologies including audit measures to track sustainability.
• Track labor and overall equipment efficiency. 

Skills: Staffing and Training, Regulatory Compliance, Production Management, Manufacturing Method Development, Scheduling and Tracking, Performance Management, Continuous Improvement, Lean Six Sigma Implementation

• Motivate employees to deliver on safety, quality and performance metrics daily within area of responsibility. 
• Work with the team to formulate and manage corrective actions to fix metrics.
• Ensure adequate manufacturing plan (employee staffing and deployment, plant capacity analysis, equipment). 
• Develop and implement manufacturing strategies to meet the sales forecast and expand the manufacturing capacity in accordance with the long-term business plan.
• Champions adherence to safety, quality, and regulatory requirements within the operations environment. 
• Work in conjunction with quality department to support compliance with the quality system, resolution of quality issues, audits, and CAPA program.
• Implement continuous improvement activities in conjunction with the CI team to support elimination of waste and improvement of efficiencies.
• Develop, mentor, and coach all direct staff. 
• Help develop organizational capacity and build future leaders for the organization.
• Participate in long term strategic planning for overall operations department 

Skills: Employee Motivation, Corrective Action Management, Manufacturing Planning, Strategic Manufacturing, Safety and Quality Compliance, Continuous Improvement, Staff Development, Leadership Development

• Leading activities around strategic planning for plant layout and configurations and supporting facilities (including offices)
• Partner with key stakeholders in R&D, Process Engineering, Supply Chain, Quality, Finance, and HR to implement operational changes and develop and execute corporate initiatives.
• Support product transfer activities from R&D into manufacturing through participation and resource deployment.
• Implement and maintain Health and Safety system to maintain a safe and healthy work environment across the organization (Scope includes office areas as well as production environment)
• Participate in company budgeting and forecasting activities 
• Establishing a budget for daily operational needs including operations expenses and hiring plans
• Establishing a capital equipment plan to address production needs
• Establishing a capital plan for building retrofits and upgrades
• Managing expenditures and capital purchases to be within annual budget

Skills: Strategic Planning, Cross-Functional Collaboration, Product Transfer, Health and Safety Management, Budgeting and Forecasting, Operational Budgeting, Capital Equipment Planning, Expenditure Management

• Experience in a similar field, preferably in a high tech or computer-related industry.
• Direct management experience.
• Experience in manufacturing, process engineering or product development
• Very familiar with SMT process and assembly process of electronics products
• Results oriented and attention to detail.
• Strong interpersonal skills and ability to present to management
• Technical expertise and prior Contract Manufacturer management experience
• Current knowledge of world class supply chain management practices
• Proven track record of achieving results and developing process improvements
• Ability to build relationships and effectively navigate in an rapidly changing environment

Qualifications: BA in Business Administration with 11 Years of Experience

• Progressive experience in microbial or mammalian biologics manufacturing or other highly regulated environment
• Supervisory/people leadership experience
• Operational and business/plant start up experience strongly 
• Brings a blend of strategic and operational expertise and a track record of leadership experience in diverse, fast changing environments and delivering strong operational results.
• Knowledge of the levers that drive revenue and margin at the business unit level. 
• Extensive experience managing a dynamic and complexed manufacturing business in a highly regulated environment.
• Must have a strong understand microbially based processes at scale, cell and gene therapy manufacturing processes, cGMP compliance, and biologics manufacturing.
• Must have the ability and desire to be an impactful leader of the business unit, who proactively identifies problems and provides solutions.
• Demonstrated leadership skills and track record of success, in hiring talent, building strong teams, obtaining results, organizational scaling, and successfully achieving business financial results.

Qualifications: BA in Supply Chain Management with 9 Years of Experience

• Working knowledge and understanding of ERP/MRP systems and their use in a manufacturing environment.
• Ability to communicate and write in English fluently.
• Skilled in business relationship management with internal and external partners
• Team-oriented with the flexibility to schedule and meet customer demands 
• Experience in manufacturing accounting and financial planning with an international organization
• Proficient in computer skills.
• Demonstrated experience and leadership in cGMP compliance audits and inspections 
• Strong leadership, coaching and motivating skills
• Must have successful PandL experience.

Qualifications: BA in Operations Management with 7 Years of Experience

• Gene therapy process development and manufacturing oversight experience 
• Demonstrated expertise in AAV biology, therapeutic vector delivery and a demonstrated ability of taking a viral vector-based product into commercial development
• Prior experience in lentiviral mediated gene therapy and non-viral gene therapies
• Experience as a contributing author of relevant CMC sections of INDs and NDAs
• Proven ability to effectively work in a team environment with internal cross functional departments and substantial experience with managing external CDMOs to meet the timelines within the approved budgets
• Ability to operate and thrive in a fast-paced, start-up environment
• Entrepreneurial mindset and ability to function in a complex and ambiguous environment
• Ability to lead, mentor and develop scientific talent at different levels
• Excellent communication and decision-making skills
• Ability to dive into technical details and discussions on active research programs

Qualifications: BA in Manufacturing Management with 7 Years of Experience

• Experience in a Manufacturing environment.
• Experience in Manufacturing Management with in-depth knowledge and understanding of manufacturing methods (including standard work), production planning, procurement and subcontract management. 
• Expertise in quality and supply chain 
• Demonstrated experience and direct responsibility for the accountability of a $100M+ manufacturing budget/facility.
• Excellent verbal and written communication skills
• Experience working in a manufacturing company with scale comparable to Vyaire
• Experience working with ERP and financial reporting systems (SAP)
• Advance analytical skills conducive to the level 
• Certified Public Accountant/Certified Management Accountant designation 
• Progressive senior financial management experience, in planning, accounting, and cost accounting capacities leading teams of larger size and scope

Qualifications: BA in Industrial Engineering with 12 Years of Experience