Manager, Clinical Lab - MLS

POSITION SUMMARY:

The Manager, Clinical Lab 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.  The Manager works closely with groups to ensure strict compliance with good manufacturing practices and CLIA/CAP guidelines at all times.  Ensures the effective use of materials, equipment and employees in producing quality products.  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.

PRIMARY RESPONSIBILITIES:

• Under direction of Senior lab leadership, and in close collaboration with other Laboratory leadership, this individual provides operational and strategic leadership to laboratory products assigned to the individual
• Generates and routinely provide 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.
• Handles employee issues: 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)
• Manages, perhaps through subordinate supervisors, the coordination of the activities of a section or department with responsibility for results, including costs, methods and staffing. In some instances, this manager may be responsible for a functional area and not have any subordinate employees
• This role works with PHI on a regular basis both in paper and electronic form and have access to various technologies to access PHI (paper and electronic) in order to perform the job
• Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire
• Performs other duties as assigned

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