Manager, Manufacturing Operations

LGC Biosearch Technologies•Middleton, WI

6d•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, sets operational priorities, manages resources and capacity, and drives performance against quality, delivery, cost, and productivity objectives. It partners with Quality Assurance, Supply Chain, Logistics, and other functions to maintain effective operations, address production and quality issues, and advance continuous improvement. Manufacturing and QC work must follow established procedures, applicable quality requirements, and organizational standards. The position oversees production and QC of biological products, production planning, laboratory testing, records and traceability, and personnel development. It leads investigations and corrective actions, monitors operational performance, and supports product introductions, transfers, change control, validation, qualification, audits, and inspections. The manager also champions employee engagement and a collaborative site culture.

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 QC laboratory activities.
Demonstrated 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.
Demonstrated operational planning and problem-solving skills, including managing competing production and testing priorities, investigating technical or quality issues, evaluating risk, and implementing 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 with biological products or laboratory-based manufacturing operations.
Experience leading or overseeing both production and QC 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 in a regulated manufacturing environment.

Responsibilities

Lead Manufacturing Operations, including production and Quality Control, to ensure biological products are manufactured and tested safely, efficiently, and according to approved procedures, specifications, and quality requirements.
Lead, develop, and manage personnel, including setting priorities, allocating resources, managing performance, developing capabilities, and maintaining training and qualification.
Plan and coordinate production and QC activities to meet 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 tested, documented, controlled, and traceable.
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 CAPA.
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 product and process improvement.
Champion site culture and employee engagement by modeling organizational values and supporting collaboration, communication, recognition, inclusion, and employee connection across functions.
Perform other duties as assigned or required to meet business needs.