VP, Clinical Laboratory Operations

Job Overview

The VP of Clinical Laboratory Operations is responsible for strategic leadership, planning and oversight of daily operations in Ambry’s clinical laboratory to ensure quality, accuracy, and timeliness of patient results. The VP serves as the functional leader of the lab management team, driving staff development, continuous improvement initiatives, and implementation of new clinical tests or workflows into laboratory operations as the business continues to evolve. As a member of Ambry’s senior leadership team, the VP also represents clinical laboratory operations on cross-functional strategic projects, budget, and operational KPIs.

Duties and Responsibilities

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  Leads the laboratory operations management staff in overseeing day-to-day operations, KPIs, scheduling, workflow, turnaround time, and adequate staffing of Ambry’s central molecular diagnostic laboratory.
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  Administers budget planning and control using responsible financial management in accordance with Ambry’s assignments of such responsibilities.
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  Sets goals and allocates resources as appropriate to the laboratory environment and its clients.
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  Leads Business Continuity Operations for the clinical laboratory.
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  Monitors results of referral / send out labs used for Clinical diagnostic testing.
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  Maintains and monitors cost of goods sold (COGS) for all active laboratory tests in partnership with the Finance team.
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  Ensures that laboratory staff are fully trained and compliant with all CLIA, FDA, CAP, and other applicable state regulatory requirements, in partnership with the Quality and Regulatory teams.
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  Provides oversight of training, professional development, and performance reviews for the laboratory operations team.
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  Implements change management systems where needed to better meet customer needs.
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  Ensures safe and efficient transition of testing platforms into Ambry’s clinical laboratory production from R&D.
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  Represents the clinical laboratory in assessing the strategic and operational impact of global business and pharma partnerships.
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  Collaborates on cross-functional teams with Laboratory Technical Directors, Genetic Counselors, Informatics, R&D, IT, Procurement, Finance, Quality, Commercial, Legal, and Compliance.
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  Provides consultative support for Ambry’s global laboratory technical transfer partners to ensure consistency of test performance across sites.
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  Stays up to date on laboratory testing industry changes, competitor actions, legal/regulatory and technology trends.
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  Up to 10% travel
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  Other duties as assigned.

Education and Knowledge

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  Bachelor's Degree in related field, Master’s degree or higher preferred
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  CA licensure as Clinical Laboratory Scientist (CLS) or Molecular Technologist (CGMBS) preferred
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  Qualifications to serve as General and Technical Supervisor under CLIA, California and New York preferred

Job Requirements

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  Strong knowledge of clinical laboratory diagnostic testing practices (CLIA, CAP, NYDOH)
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  Experience with molecular-based clinical testing methods, including NGS (preferred)
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  Understanding of HIPAA and importance of privacy of patient data
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  PC proficiency with Microsoft Office Suite and proficiency with office software applications, and basic use of Laboratory Information Management Systems (LIMS)
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  Familiarity with FDA quality system regulations, ISO 15189 and/or ISO 13485 standards
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  Track record of strong leadership skills tied with timely achievement of goals.
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  Ability to foster a high performing, teamwork-oriented laboratory environment.
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  Ability to act as a team player and mentor.
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  Ability to lead, teach, and persuade others.
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  Commitment to Ambry’s core values: Open and Honest, Customer Centric, Innovative, Passionate, and Accountable.
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  Excellent verbal and communications skills. Ability to write routine reports and correspondence. Ability to speak effectively one-to-one, in group settings, with clients and employees of the organization. High level of presentation skills.
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  Ability to add, subtract, multiply, and divide using whole numbers, common fractions, and decimals. Basic understanding of statistical methods and application to the analysis of diagnostic assay performance and trends.
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  Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Flexibility in problem solving in a team-setting and highly matrixed-environment. Open to giving and receiving constructive feedback with a growth-mindset.
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  Certificates, Licenses, Registrations- ASCP and CA state licensed in Molecular Biology or equivalent (preferred)
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  8 years of clinical laboratory experience and progressive leadership (at least 3 years in molecular testing)
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  Experience in process and quality improvement methodologies (Lean, Six Sigma) is preferred.

ABOUT US:

Ambry Genetics Corporation is a CAP-accredited and CLIA-licensed molecular genetics laboratory based in Aliso Viejo, California. We are a genetics-based healthcare company that is dedicated to open scientific exchange so we can work together to understand and treat all human disease faster.

At Ambry, everyone is welcome. A career at Ambry Genetics is a chance to be part of a dynamic company that aims to improve health by understanding the relationships between genetics and human disease. We earned our reputation as industry leaders by responsibly introducing cutting-edge genetic testing solutions and continually sharing what we learn with the global scientific community. We also support those with genetic conditions through the Mauli Ola Foundation and other nonprofit organizations. At Ambry you will be learning, challenging yourself, and having fun while collaborating with teammates through the open exchange of ideas.

Employees at Ambry Genetics have many perks, including an onsite café with complimentary smoothies and infused waters! We also offer access to gym memberships, onsite food trucks, “Lunch and Learns,” Pajama Days, Chili Cook-Offs and more. Our outstanding benefits program includes medical, dental, vision, 401k, FSA, generous paid time off (PTO) program, and flexible scheduling as determined appropriate.

Ambry Genetics is an Equal Opportunity Employer (EOE) and we maintain a drug-free work environment.


Ambry Genetics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.