Director of Operations-Life Sciences

Solesis•Winston-Salem, NC

About The Position

The Director of Operations provides strategic and operational leadership for Charter Medical’s site, with full accountability for P&L performance, manufacturing excellence, and sustainable, profitable growth in single-use cell processing and biopharmaceutical manufacturing. The role translates the company’s mission into operating priorities that advance customizable processing solutions, reduce the cost and risk of delivering advanced therapies, and enable customers to scale reliably. The Director aligns capacity, capital investment, innovation, quality, and workforce capability with customer demand while fostering a culture of safety, compliance, responsiveness, collaboration, urgency, and continuous improvement. Charter Medical is part of the Solesis family of companies and specializes in single-use solutions for life sciences innovators. The company operates two facilities in Winston-Salem, North Carolina, and employs more than 150 team members. This role leads site manufacturing operations and related functions, supports customer and product growth, and helps bring life-changing therapies to market. The schedule is first shift, Monday through Friday, 8:00 a.m. to 5:00 p.m.

Requirements

Bachelor’s degree in engineering, operations, business, life sciences, or a related field, or an equivalent combination of education and relevant experience.
At least 10 years of progressive manufacturing experience, including significant experience in regulated life sciences, biopharmaceutical, medical device, or a comparable environment.
At least 4 years of experience in manufacturing management, plant leadership, or a 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, including 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.
Must be authorized to work in the United States without employment visa sponsorship, both now and in the future.

Nice To Haves

Lean Six Sigma certification.
Experience in cleanroom manufacturing.
Experience supporting biopharmaceutical customers, customer audits, and contract manufacturing operations.
Experience leading capacity expansion, automation, technology transfer, or operational transformation initiatives.

Responsibilities

Lead site manufacturing operations to ensure safe, compliant, reliable, and profitable execution of customer demand.
Own site P&L performance, including revenue, 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.
Manage labor, equipment, materials, information, and facility capacity to improve throughput, yield, lead time, asset utilization, and on-time delivery.
Establish and act on performance indicators and trends through daily, weekly, monthly, quarterly, and annual operating reviews.
Evaluate and improve manufacturing methods based on product requirements, materials, fabrication processes, tooling, equipment capability, work methods, and quality-control standards.
Lead capacity planning and resource allocation for current production, new business, customer growth, and future site needs.
Develop, justify, prioritize, and execute capital investment plans for safety, compliance, capacity, automation, productivity, business continuity, and site growth.
Lead improvement initiatives focused on safety, quality, delivery, yield, scrap, labor productivity, cost reduction, flow, and equipment reliability.
Ensure product availability through disciplined production planning 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.
Partner with Commercial and Product Development teams to assess manufacturing capability, support customer opportunities, align operational commitments, and respond to demand changes.
Represent manufacturing during customer visits, business reviews, audits, regulatory inspections, CAPA activities, and issue resolution.
Ensure manufacturing execution meets product specifications, documentation, and traceability requirements and supports compliant delivery.
Build and maintain manufacturing training and qualification programs in partnership with Human Resources.
Develop operating budgets, forecasts, staffing plans, productivity targets, and capital plans; monitor results and take corrective action when performance falls below plan.
Oversee product-costing inputs with Finance, using actual manufacturing performance, labor productivity, yields, scrap, material usage, and operational assumptions.
Identify staffing needs, participate in hiring, and build organizational capability for operational and growth requirements.
Coach, mentor, and develop operations leaders and employees; set expectations, provide feedback, manage performance, and support succession and career development.
Partner with Human Resources on organizational structure, talent reviews, employee engagement, and leadership capability.
Foster 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 communication across shifts, departments, and leadership so priorities, risks, decisions, and customer commitments are understood.
Independently use judgment and initiative to resolve complex manufacturing and business issues and develop recommendations for senior leadership.