Advanced Sterilization Products
VSM Laboratory Manager (Biologics Industry)
Advanced Sterilization Products, Irvine, California, United States, 92713
VSM Laboratory Manager (Biologics Industry)
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VSM Laboratory Manager (Biologics Industry)
role at
Advanced Sterilization Products
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.
About Advanced Sterilization Products ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low‑temperature hydrogen peroxide sterilization technology. ASP’s mission is to protect patients during their most critical moments. We support healthcare facilities in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality. ASP’s products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning.
Bonus and Equity Bonus is part of the total compensation package.
Pay Range 99,700.00 – 185,000.00 (local currency)
Equal Opportunity Employer 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.
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VSM Laboratory Manager (Biologics Industry)
role at
Advanced Sterilization Products
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.
About Advanced Sterilization Products ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low‑temperature hydrogen peroxide sterilization technology. ASP’s mission is to protect patients during their most critical moments. We support healthcare facilities in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality. ASP’s products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning.
Bonus and Equity Bonus is part of the total compensation package.
Pay Range 99,700.00 – 185,000.00 (local currency)
Equal Opportunity Employer 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.
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