VSM Laboratory Manager (Biologics Industry) - Fortive Corporation
Irvine, CA
About the Job
Job Description: Laboratory Manager (Biologics Industry)
Position Overview: We are seeking a highly skilled Laboratory Manager with expertise in FBS methodologies and a strong background in managing non-conformance processes, equipment/process validations, and equipment qualifications within the biologics industry. The candidate will oversee daily laboratory operations, ensuring compliance with regulatory standards while driving continuous improvement initiatives to enhance efficiency and quality.
Responsibilities:
+ Laboratory Operations Oversight:
+ Manage and coordinate all aspects of laboratory operations, including scheduling, resource allocation, and workflow management.
+ Ensure adherence to standard operating procedures (SOPs), safety protocols, and regulatory requirements (e.g., FDA, GMP).
+ Lean Six Sigma Implementation:
+ Apply FBS principles to identify opportunities for process improvement and waste reduction in laboratory workflows.
+ Lead Lean projects aimed at enhancing operational efficiency, quality control, and overall productivity.
+ Non-Conformance Processes Management:
+ Develop and maintain procedures for investigating non-conformances, identifying root causes, and implementing corrective/preventive actions (CAPAs).
+ Ensure effective implementation of CAPA plans to address non-conformances and prevent recurrence.
+ Equipment and Process Validations:
+ Oversee equipment validations (IQ/OQ/PQ) and process validations to ensure compliance with specifications and performance criteria.
+ Collaborate with validation teams and stakeholders to execute protocols and document validation activities.
+ Quality Assurance and Compliance:
+ Conduct quality assurance activities, including internal audits, inspections, and documentation reviews to maintain regulatory compliance.
+ Implement quality control measures to ensure accurate and timely completion of testing and reporting.
+ Leadership and Team Development:
+ Provide leadership and mentorship to laboratory staff, fostering a culture of teamwork, continuous learning, and professional development.
+ Conduct training sessions on FBS methodologies, quality assurance practices, and regulatory compliance for laboratory personnel.
+ Cross-Functional Collaboration:
+ Collaborate with R&D, manufacturing, and regulatory affairs teams to support product development and commercialization efforts.
+ Communicate effectively with senior management, presenting laboratory performance metrics, project updates, and improvement recommendations.
Qualifications:
+ Bachelor’s degree in Biology, Biochemistry, Chemistry, Engineering, or related field; advanced degree (e.g., MS, PhD) preferred.
+ Minimum of 5 years of experience in laboratory management within the biologics or pharmaceutical industry.
+ Strong proficiency in continuous improvement methodologies with certification (e.g., Green Belt, Black Belt) and practical application experience.
+ Expertise in managing non-conformance processes, equipment/process validations, and equipment qualifications.
+ Thorough knowledge of regulatory requirements (e.g., FDA, GMP) governing biologics laboratory operations.
+ Experience with quality management systems (QMS) implementation and internal auditing.
+ Excellent leadership, organizational, and communication skills with the ability to lead teams and collaborate effectively across departments.
Fortive Corporation Overview
Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.
We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.
We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.
At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference.
At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.
Fortive: For you, for us, for growth.
This position is also eligible for bonus as part of the total compensation package.
The salary range for this position (in local currency) is 99,700.00 - 185,000.00. Base pay offered may vary depending on various factors, including, but not limited to: job-related knowledge; skills; experience; and other eligibility factors such as geographic location. The Total Rewards package includes competitive base pay and an opportunity to enroll in a variety of benefit programs, generally including health insurance, flexible spending accounts, health savings accounts, retirement savings plans, life and disability insurance programs, and several programs that provide for both paid and unpaid time away from work.
We are an Equal Opportunity Employer
Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at applyassistance@fortive.com.
Position Overview: We are seeking a highly skilled Laboratory Manager with expertise in FBS methodologies and a strong background in managing non-conformance processes, equipment/process validations, and equipment qualifications within the biologics industry. The candidate will oversee daily laboratory operations, ensuring compliance with regulatory standards while driving continuous improvement initiatives to enhance efficiency and quality.
Responsibilities:
+ Laboratory Operations Oversight:
+ Manage and coordinate all aspects of laboratory operations, including scheduling, resource allocation, and workflow management.
+ Ensure adherence to standard operating procedures (SOPs), safety protocols, and regulatory requirements (e.g., FDA, GMP).
+ Lean Six Sigma Implementation:
+ Apply FBS principles to identify opportunities for process improvement and waste reduction in laboratory workflows.
+ Lead Lean projects aimed at enhancing operational efficiency, quality control, and overall productivity.
+ Non-Conformance Processes Management:
+ Develop and maintain procedures for investigating non-conformances, identifying root causes, and implementing corrective/preventive actions (CAPAs).
+ Ensure effective implementation of CAPA plans to address non-conformances and prevent recurrence.
+ Equipment and Process Validations:
+ Oversee equipment validations (IQ/OQ/PQ) and process validations to ensure compliance with specifications and performance criteria.
+ Collaborate with validation teams and stakeholders to execute protocols and document validation activities.
+ Quality Assurance and Compliance:
+ Conduct quality assurance activities, including internal audits, inspections, and documentation reviews to maintain regulatory compliance.
+ Implement quality control measures to ensure accurate and timely completion of testing and reporting.
+ Leadership and Team Development:
+ Provide leadership and mentorship to laboratory staff, fostering a culture of teamwork, continuous learning, and professional development.
+ Conduct training sessions on FBS methodologies, quality assurance practices, and regulatory compliance for laboratory personnel.
+ Cross-Functional Collaboration:
+ Collaborate with R&D, manufacturing, and regulatory affairs teams to support product development and commercialization efforts.
+ Communicate effectively with senior management, presenting laboratory performance metrics, project updates, and improvement recommendations.
Qualifications:
+ Bachelor’s degree in Biology, Biochemistry, Chemistry, Engineering, or related field; advanced degree (e.g., MS, PhD) preferred.
+ Minimum of 5 years of experience in laboratory management within the biologics or pharmaceutical industry.
+ Strong proficiency in continuous improvement methodologies with certification (e.g., Green Belt, Black Belt) and practical application experience.
+ Expertise in managing non-conformance processes, equipment/process validations, and equipment qualifications.
+ Thorough knowledge of regulatory requirements (e.g., FDA, GMP) governing biologics laboratory operations.
+ Experience with quality management systems (QMS) implementation and internal auditing.
+ Excellent leadership, organizational, and communication skills with the ability to lead teams and collaborate effectively across departments.
Fortive Corporation Overview
Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.
We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.
We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.
At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference.
At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.
Fortive: For you, for us, for growth.
This position is also eligible for bonus as part of the total compensation package.
The salary range for this position (in local currency) is 99,700.00 - 185,000.00. Base pay offered may vary depending on various factors, including, but not limited to: job-related knowledge; skills; experience; and other eligibility factors such as geographic location. The Total Rewards package includes competitive base pay and an opportunity to enroll in a variety of benefit programs, generally including health insurance, flexible spending accounts, health savings accounts, retirement savings plans, life and disability insurance programs, and several programs that provide for both paid and unpaid time away from work.
We are an Equal Opportunity Employer
Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at applyassistance@fortive.com.
Source : Fortive Corporation
