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.
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