Clinical Laboratory Operations Manager

4 weeks ago

Austin, Texas, United States Natera Full time

Job Summary:

The Clinical Laboratory Operations Manager is a key leader in Natera's lab operations who oversees and directs the development, planning, implementation, and maintenance of manufacturing methods, processes, and operations for new or existing products and technologies.

This role works closely with groups to ensure strict compliance with good manufacturing practices and CLIA/CAP guidelines at all times.

The Manager ensures the effective use of materials, equipment, and employees in producing quality products. They monitor and control staffing/labor, capital expenditures, and manufacturing performance. Develops budget and monitors expenditures. Formulates and recommends manufacturing policies, procedures, and programs. Selects, develops, and evaluates line-management to ensure the efficient operation of the function.

Key Responsibilities:

  • Provides operational and strategic leadership to laboratory products assigned to the individual
  • Generates and routinely provides executive-level production/departmental summaries
  • Monitors workflow and ensures production goals and deadlines are met (e.g. TAT, SLA)
  • Engages in future planning and scales employees and equipment appropriately
  • Gathers and monitors metrics on production deadlines, efficiency, scrap waste, and error rates
  • Monitors the quality control/assurance programs, test results, and equipment (if applicable)
  • Uses metrics in decision-making and to drive changes across the team (e.g. cost reduction, quality improvement)
  • Manages sufficient headcount levels to meet production goals by proactively driving the interview process and managing employee PTO and overtime when necessary
  • Refines current lab process through continuous improvement projects
  • Oversees team-specific lab operation
  • Go-to person when Senior lab leadership is not present; go-to person for knowledge of process and product
  • Responsible for seamless transition of automation and test improvement/additions into production workflow while adhering to the proper change control process
  • Analyzes and troubleshoots lab processing errors; provides recommendations on how to proceed to lab director, scientists, and statisticians as necessary
  • Supports Supervisors in close out of NCRs
  • Responsible for the initiation and close out of CAPAs in a timely manner
  • Ensures departmental lab compliance for regulatory bodies
  • Ensures tests are being completed according to approved procedures
  • Maintains an organized, safe, and efficient work area for the team at all times
  • Actively interacts with interdepartmental teams such as OPS, Accessioning, Engineering, Stats, R&D, and Support

Employee Issues:

  • Handles employee complaints, disciplinary actions, etc. Collaborates with Senior Manager and/or Human Resources to resolve issues
  • Knows and is ready to explain Natera's core values
  • Explains (as much as possible) reasoning behind instructions/processes given/changes that are made. If necessary, explains to team why certain ideas cannot be implemented effectively
  • Meets regularly with Supervisors to discuss goals and progress
  • Performs routine skip-levels with individual team members
  • Responsible for performance review of direct reports and overseeing performance review of entire staff
  • Plans and leads team meetings
  • Develops high-performing employees by providing them with learning opportunities, cross-training opportunities, and new challenges whenever possible
  • Recognizes and rewards talent through merit reviews, promotions, and recognition programs
  • Adheres to Departmental Expectations
  • Manages the training program for direct reports
  • Notifies management of all requirements for tools, supplies, etc.
  • Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals
  • Provides guidance to subordinates within the latitude of established company policies
  • Recommends changes to policies and establishes procedures that affect immediate organization(s)

Qualifications:

  • BS/BA degree (or equivalent) in Medical Technology program with 4 years CLIA laboratory experience
  • BS/BA, Physical, Chemical, or Biological Sciences, or a related field 5 years experience in a CLIA laboratory
  • Master's degree in arts or science with a major in chemical, physical, or biological sciences with 3 years experience in a CLIA laboratory
  • Master's degree with BS/BA in Medical Technology program with 2 years experience in a CLIA laboratory
  • A minimum of 3+ years of relevant leadership experience and/or effectively managing a team preferred
  • Current MT/MLS/CLS/MB certification preferable from ASCP, AMT, or AAB

Knowledge, Skills, and Abilities:

  • Exceptional multi-tasking, organizational, and communication skills
  • Excellent computer skills, including MS Excel and Google Suite
  • Strong problem-solving and prioritization skills
  • Independent self-starter comfortable working in teams at all levels
  • Experience in building and managing a high-performing group of engaged and motivated employees
  • Experience with working on a Laboratory Operations floor
  • Knowledge and experience with Lean Six Sigma concepts and tools
  • Experience with LIMS and SQL queries preferred
  • Manufacturing/Engineering experience preferred

About Natera:

Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers, and many other professionals from world-class institutions, who care deeply for our work and each other.

When you join Natera, you'll work hard and grow quickly. Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

About Our Opportunity:

Natera offers a competitive benefits package, including comprehensive medical, dental, vision, life, and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits, and much more. We also offer a generous employee referral program.

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities, and perspectives. Inclusive collaboration benefits our employees, our community, and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability, or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.

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