Manager, Manufacturing Operations

Lgc-; Town of Middleton (WI); On-site; USD 120,000 - 170,000; Full time

Job summary

LGC Biosearch Technologies seeks a Manager, Manufacturing Operations to lead on-site production and QC activities, ensuring safe, compliant, and efficient manufacture and testing of products. This role manages personnel, priorities, resources and training while aligning with QA, supply chain, and other functions to support product quality and delivery.

The ideal candidate has deep experience in regulated manufacturing, strong leadership, and a track record of CAPA, continuous improvement, and

Qualifications

• Bachelor’s degree in biology, microbiology, biochemistry, biotechnology, chemistry, engineering, operations, or a related discipline, or equivalent experience.
• Experience in a regulated manufacturing environment with production and/or QC laboratory activities.
• Proven leadership of technical or operational teams and effective resource management.
• Working knowledge of QMS, controlled documentation, CAPA, change control, and audits.
• Ability to prioritize, assess risk, and implement corrective actions in production settings.

Responsibilities

• Lead production and QC activities, ensuring safe, compliant, and efficient manufacturing and testing.
• Develop and manage personnel, set priorities, allocate resources, and ensure training and qualification.
• Plan production/QC schedules to meet product-release requirements and commitments.
• Ensure records comply with QMS, ISO standards, and regulatory requirements.
• Investigate deviations and CAPA, driving root-cause analysis and corrective actions.
• Drive continuous improvement in quality, yield, and delivery performance.
• Collaborate with QA, supply chain, logistics, and other functions on transfers and changes.

Skills

People leadership

QMS knowledge

Regulated manufacturing

Process improvement

Cross-functional collaboration

Documentation & audit readiness

Problem solving

Education

Bachelor’s degree in biology or related scientific field

Job description

• Department: Production and Skilled Trades

Company Description

With manufacturing sites across the US, UK, Germany and Denmark, LGC Biosearch Technologies has plans to continue growing. We deliver mission critical genomics to our diverse customer base in molecular diagnostics, pharma/biotech and agrigenomics. Our integrated portfolio of products, services and expertise supports our purpose of Science for a Safer World and we have embodied our mission by working with customers to enable research into life-altering treatment for disease and illness worldwide. We are currently seeking candidates who are up for the challenge of operating in a high-growth, purpose-driven organisation.

Job Description

The Manager, Manufacturing Operations provides on-site leadership and oversight for production and quality control (QC) activities to support the safe, compliant, efficient, and consistent manufacture and testing of products at the company's site. This role leads personnel within the relevant function, establishes operational priorities, manages resources and capacity, and drives performance against quality, delivery, cost, and productivity objectives. The Manager partners cross-functionally with Quality Assurance, Supply Chain, Logistics, and other functions to maintain effective operations, resolve production and quality-related issues, and drive continuous improvement. The role is responsible for ensuring manufacturing and QC activities are performed in accordance with established procedures, applicable quality requirements, and organizational standards.

• Lead Manufacturing Operations, including production and Quality Control (QC), 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 under overall remit, establishing 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 (QMS), ISO requirements, approved procedures, good documentation practices, and applicable safety and regulatory requirements
• Oversee QC testing and associated 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 (CAPA)
• Drive operational excellence and continuous improvement by monitoring quality, productivity, yield, testing, and delivery performance and implementing improvements to processes, methods, equipment, workflows, and capacity
• Partner cross-functionally with Quality Assurance and other technical and business functions to support 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, modeling organizational values and actively supporting initiatives that strengthen collaboration, communication, recognition, inclusion, and employee connection across functions
• Perform other duties as assigned or required to meet business needs

Qualifications

Essential Qualifications:

• 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
• Demonstrated people leadership experience, including leading and developing technical or operational teams, establishing priorities, allocating resources, managing performance, and building employee capability and engagement
• Working knowledge of Quality Management Systems (QMS) and regulated manufacturing practices, including controlled documentation, deviations and nonconformances, CAPA, change control, traceability, and audit readiness
• Demonstrated operational planning and problem-solving skills, with 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, with demonstrated ability to collaborate effectively with Quality Assurance, technical teams, supply chain, and other business functions

Desired Qualifications

• 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 operating 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 activities
• Demonstrated 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

Additional Information

ABOUT LGC:

LGC is a leading, global life science tools company, providing mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Its high-quality product portfolio is comprised of mission-critical tools for genomic analysis and for quality assurance applications, which are typically embedded and recurring within our customers’ products and workflows and are valued for their performance, quality, and range.

OUR VALUES

• PASSION
• CURIOSITY
• INTEGRITY
• BRILLIANCE
• RESPECT

EQUAL OPPORTUNITIES

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or maternity, religion, or belief. Short listing, interviewing and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership.

This position requires current U.S. work authorization. We are unable to sponsor or assume sponsorship for temporary visas (including H‑1B, H‑2B, OPT, O‑1, TN)