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Description
Inter Science Institute (ISI) is seeking a highly motivated Assistant Laboratory Director to help lead scientific excellence in a high-complexity clinical laboratory specializing in neuroendocrine and biomarker analysis.
The laboratory performs high complexity clinical chemistry testing through a specialized menu of internally developed laboratory-developed tests (LDTs) supporting clinical and research applications.
Working closely with the CEO and Laboratory Director, the Assistant Laboratory Director will provide scientific leadership across laboratory operations, research initiatives, and clinical testing programs. This role is ideal for a scientist with strong advanced chemistry expertise and an interest in the neuroendocrine field.
The Assistant Laboratory Director will play a critical role in maintaining regulatory excellence while also supporting method development, analytical innovation, and cross-disciplinary collaboration across scientific and administrative teams.
Requirements
- Provide scientific oversight and strategic leadership for laboratory operations, clinical testing, and research initiatives.
- Supervise and mentor a team of approximately 10 Clinical Laboratory Scientists (CLS) and Trainee’s (CLT’s) while promoting a culture of scientific excellence and continuous improvement.
- Collaborate across laboratory, accessioning, and administrative departments to optimize workflows, resolve technical challenges, and ensure timely completion of projects.
- Serves as a company representative during laboratory inspections and regulatory audits, working closely with the Laboratory Director.
- Support research and development initiatives, including evaluation and implementation of new technologies and methodologies.
- Lead quality assurance activities, including monthly monitoring, quality management system, and internal audits.
- Review and author reports, protocols, validation documents, scientific summaries, scientific publications, IRB protocols, standard operating procedures and related materials with directors.
- Serve as QA Manager and Technical Supervisor in accordance with regulatory requirements.
- Contribute to the development, preparation, and oversight of SOPs, policies, internal audits, and quality monitoring systems.
- Provide scientific expertise for client interactions, collaborations, and technical consultations.
- Participate in the evaluation and development of laboratory managers, supervisors, and coordinators.
- Support recruitment of scientific staff and collaborate with HR on regulatory documentation and onboarding.
- Prepare and present quarterly departmental reviews to executive leadership.
- Assume delegated Laboratory Director responsibilities when required.
Minimum Qualifications
- Doctoral or master's or bachelor's degree in chemistry, biochemistry, physical, biological, or clinical laboratory science from an accredited institution.
- 5+ years of laboratory experience in a CLIA certified organization
- California Clinical Laboratory Scientist (CLS) - Generalist or Clinical Chemistry limited license preferred or ability to take the ASCP certification exam upon hire.
- Strong knowledge of state, federal, and regulatory compliance requirements, including laboratory safety and radiation safety.
- Demonstrated knowledge of CAP, CLIA and ISO requirements.
- Demonstrated experience with data analysis and interpretation.
- Proficiency in Microsoft Office and Adobe.
Skills & Leadership Competencies
- Excellent communication and interpersonal skills with the ability to lead multidisciplinary teams.
- Proven leadership skills and ability to work with some supervision and guidance.
- Ability to independently assess technical solutions, evaluate projects, and define validation and performance standards
- Ability to respond effectively to inquiries from clients, regulatory agencies, and leadership.
- Strong presentation skills with experience communicating scientific and operational information to executive leadership.
- Ability to maintain strict confidentiality, including HIPAA compliance and internal policies.
- Commitment to professional accountability, feedback, and modeling high standards of conduct.