Manager, Manufacturing Operations
Middleton, ID - USA
Job Summary
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 companys 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:
- Bachelors 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 H1B H2B OPT O1 TN)
For more information about LGC please visit our website
#scienceforasaferworld
Remote Work :
No
Employment Type :
Full-time
About Company
With over 180 years of scientific heritage and operations in 14 countries, our products and services are integral to the industries that safeguard our food, water, medicine, and environment. Working collaboratively with our partners across the scientific community, our solutions addr ... View more