Director of Operations and Site Lead-Life Sciences

Job Description

Job Description

Who we are:

Charter Medical, part of the Solesis family of companies, specializes in single-use solutions that enable life sciences innovators to turn bold ideas into lasting breakthroughs, supporting industry-leading companies in bringing life-saving therapies to market. Operating in North Carolina, Charter Medical employs more than 150 team members across two facilities in Winston-Salem.

Guided by a commitment to quality, innovation and customer success, Charter partners with customers to transform promising therapies into commercial realities. Employees contribute to solutions that support life-changing treatments and make a meaningful impact on patients around the world.

1st shift Monday-Friday 8:00 am-5:00 pm

About the role:

The Director of Operations provides strategic and operational leadership for the site, with full accountability for Profit & Loss (P&L) performance, manufacturing excellence, and sustainable, profitable growth in single-use cell processing and biopharmaceutical manufacturing. The role translates Charter Medical’s mission into operating priorities that advance purpose-built, customizable processing solutions, reduce the cost and risk of delivering advanced therapies, and enable customers to scale reliably. By aligning capacity, capital investment, innovation, quality, and workforce capability with customer demand, the Director fosters a culture of safety, compliance, responsiveness, collaboration, urgency, and continuous improvement—helping biopharmaceutical innovators make life-changing therapies more accessible to patients.

What you will do:

• Lead all site manufacturing operations to ensure safe, compliant, reliable, and profitable execution of customer demand.
• Own site P&L performance, including revenue attainment, EBITDA, gross margin, labor and overhead management, productivity, spending, savings, and budget execution.
• Develop and execute the site operating plan and manufacturing strategy in alignment with company objectives, customer demand, and growth priorities.
• Direct manufacturing execution, facilities, maintenance, and continuous improvement activities to achieve Safety, Quality, Delivery, Cost, and People objectives.
• Ensure effective utilization of labor, equipment, materials, information, and facility capacity to improve throughput, yield, lead time, asset utilization, and on-time delivery.
• Establish, review, and act on key performance indicators and performance trends through daily, weekly, monthly, quarterly, and annual operating reviews.
• Evaluate and improve manufacturing methods using knowledge of product requirements, materials, fabrication processes, tooling, equipment capability, work methods, and quality-control standards.
• Lead capacity planning and resource allocation to support current production, new business, customer growth, and future site requirements.
• Develop, justify, prioritize, and execute capital investment plans supporting safety, compliance, capacity, automation, productivity, business continuity, and site growth.
• Lead continuous improvement initiatives focused on safety, quality, delivery, yield, scrap, labor productivity, cost reduction, flow, and equipment reliability.
• Ensure product availability through disciplined execution of the production plan and alignment of labor, materials, equipment, and technical support.
• Support new-product introductions, technology transfers, pilot builds, process scale-up, design-for-manufacturability reviews, product validations, and commercialization activities.
• Partner with Commercial and Product Development teams to assess manufacturing capability, support customer opportunities, align operational commitments, and respond to changing demand.
• Serve as the senior manufacturing representative during customer visits, business reviews, audits, regulatory inspections, CAPA activities, and issue-resolution efforts.
• Ensure manufacturing execution meets product specifications, documentation, and traceability requirements and supports compliant delivery.
• Build and maintain robust manufacturing training and qualification programs in partnership with Human Resources.
• Develop annual operating budgets, forecasts, staffing plans, productivity targets, and capital plans; monitor performance and implement corrective actions when results fall below plan.
• Oversee product-costing inputs based on actual manufacturing performance, labor productivity, yields, scrap, material usage, and operational assumptions in partnership with Finance.
• Identify staffing requirements; participate in selection and hiring; build organizational capability to meet operational and growth requirements.
• Coach, mentor, and develop operations leaders and employees; establish clear expectations, provide ongoing feedback, manage performance, and support succession and career development.
• Partner with Human Resources to maintain an effective organization structure, conduct talent reviews, improve employee engagement, and develop leadership capability.
• Foster a culture of safety, accountability, quality, customer focus, collaboration, disciplined execution, and continuous improvement throughout the site.
• Ensure adherence to site safety requirements, PPE practices, environmental expectations, and applicable Health, Safety, and Environmental systems.
• Maintain strong communication across shifts, departments, and leadership so priorities, risks, decisions, and customer commitments are clearly understood.
• Act independently with a high degree of judgment and initiative to resolve complex manufacturing and business issues and develop recommendations for senior leadership.

Please note that Charter Medical does not provide employment visa sponsorship for this position. Candidates must be authorized to work in the United States without sponsorship both now or in the future.

Who you are:

• Bachelor's degree in engineering, operations, business, life sciences, or a related field, or an equivalent combination of education and relevant experience.
• Minimum of 10 years of progressive manufacturing experience, including significant experience in a regulated life sciences, biopharmaceutical, medical device, or comparable environment.
• Minimum of 4 years of experience in manufacturing management, plant leadership, or director-level role.
• Demonstrated experience owning or significantly influencing a manufacturing P&L, operating budget, productivity plan, and capital portfolio.
• Demonstrated ability to lead managers and cross-functional teams, coach employees, resolve conflict, and drive accountability.
• Working knowledge of Good Manufacturing Practices, FDA expectations, ISO-based quality systems, and regulated manufacturing documentation.
• Strong understanding of manufacturing processes, production planning, equipment capability, facilities, maintenance, cost drivers, and operational workflows.
• Considerable knowledge of ERP systems and proficiency with Microsoft Excel, Word, PowerPoint, and Outlook.
• Effective written, verbal, presentation, analytical, and interpersonal skills, with the ability to work across shared-service and matrixed organizations.
• Ability to use Lean Six Sigma and structured problem-solving methods to improve safety, quality, delivery, cost, and business performance.
• Lean Six Sigma certification preferred.
• Experience in cleanroom manufacturing preferred.
• Experience supporting biopharmaceutical customers, customer audits, and contract manufacturing operations preferred.
• Experience leading capacity expansion, automation, technology transfer, or operational transformation initiatives preferred.

Perks / Benefits:

• Generous Paid Time Off
• Paid Breaks
• Annual Bonus
• 401(k) with excellent company match
• Health Insurance with multiple plans to choose from
• Paid Short Term and Long Term Disability