Manager, Manufacturing Operations

LGC Group•Middleton, WI

3h•Onsite

About The Position

The Manager, Manufacturing Operations provides on-site leadership and oversight for production and quality control (QC) activities, supporting the safe, compliant, efficient, and consistent manufacture and testing of products. The role leads personnel within the relevant function, sets operational priorities, manages resources and capacity, and drives performance against quality, delivery, cost, and productivity objectives. The Manager works with Quality Assurance, Supply Chain, Logistics, and other functions to maintain effective operations, resolve production and quality issues, and advance continuous improvement. Manufacturing and QC activities must follow established procedures, applicable quality requirements, and organizational standards.

Requirements

Bachelor’s degree in biology, microbiology, biochemistry, biotechnology, chemistry, engineering, operations, or a related scientific or technical discipline, or an equivalent combination of relevant education and professional experience.
Relevant experience in a regulated manufacturing environment, with demonstrated knowledge of manufacturing operations, production processes, and/or quality control laboratory activities.
People leadership experience, including leading and developing technical or operational teams, setting priorities, allocating resources, managing performance, and building employee capability and engagement.
Working knowledge of Quality Management Systems and regulated manufacturing practices, including controlled documentation, deviations and nonconformances, CAPA, change control, traceability, and audit readiness.
Operational planning and problem-solving skills, including the ability to manage competing production and testing priorities, investigate technical or quality issues, evaluate risk, and implement effective solutions.
Strong written, verbal, and cross-functional communication skills, including the ability to collaborate with Quality Assurance, technical teams, supply chain, and other business functions.
Current U.S. work authorization; the company is unable to sponsor or assume sponsorship for temporary visas, including H-1B, H-2B, OPT, O-1, and TN.

Nice To Haves

Experience in biologics, biotechnology, life sciences, diagnostics, or a related manufacturing environment, particularly involving biological products or laboratory-based manufacturing operations.
Experience leading or overseeing both production and Quality Control functions, including laboratory testing, manufacturing workflows, resource planning, and operational performance.
Knowledge of ISO 13485 or other applicable ISO quality standards, including experience working within an ISO-certified Quality Management System.
Experience with investigations, root-cause analysis, CAPA, risk management, process or method validation, equipment qualification, and/or technology transfer.
Experience with Lean, continuous improvement, or operational excellence methodologies and using quality and operational metrics to improve productivity, quality, yield, or delivery performance.
Experience supporting internal, customer, or regulatory audits and inspections within a regulated manufacturing environment.

Responsibilities

Lead Manufacturing Operations, including production and Quality Control, ensuring biological products are manufactured and tested safely, efficiently, and in accordance with approved procedures, specifications, and applicable quality requirements.
Lead, develop, and manage personnel by setting priorities, allocating resources, managing performance, developing technical and business capabilities, and maintaining appropriate training and qualification.
Plan and coordinate production and QC activities to meet manufacturing schedules, testing and product-release requirements, capacity needs, and customer commitments.
Ensure manufacturing and QC activities and records comply with the Quality Management System, ISO requirements, approved procedures, good documentation practices, and applicable safety and regulatory requirements.
Oversee QC testing and laboratory activities, ensuring materials and products are appropriately tested, documented, controlled, and traceable throughout manufacturing operations.
Lead and support investigations of manufacturing and QC issues, including deviations, nonconformances, testing issues, and process failures; partner with Quality Assurance on root-cause analysis and corrective and preventive actions.
Drive operational excellence and continuous improvement by monitoring quality, productivity, yield, testing, and delivery performance and improving processes, methods, equipment, workflows, and capacity.
Partner with Quality Assurance and other technical and business functions on product introductions, process and method transfers, change control, validation and qualification activities, audits, inspections, and ongoing product and process improvement.
Champion site culture and employee engagement by modeling organizational values and supporting initiatives that strengthen collaboration, communication, recognition, inclusion, and employee connection across functions.
Perform other duties as assigned or required to meet business needs.