Manager, Clinical Lab

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 the 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 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 operations.

• 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 a production workflow

• Analyzes and troubleshoots lab processing errors; provides recommendations on how to proceed to lab director, scientists, and statisticians as necessary

• Supports Supervisors in the closeout of NCRs.

• Responsible for the initiation and closeout 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.

• Handle 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 the 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 the 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.

QUALIFICATIONS:

• BS/BA degree in Biological Sciences, related field, or equivalent

• A minimum of 3+ years of relevant leadership experience and/or effectively managing a team preferred

• A minimum of 5+ years of industry-related experience preferred

• Current ASCP board certification in Medical Technology or California State CLS or CGMBS license (Clinical Genetics Molecular Biologist Scientist) is required

KNOWLEDGE, SKILLS, AND ABILITIES:  

• Exceptional multi-tasking, organizational, and communication skills.

• Excellent computer skills, including MS Excel.

• Able to be detailed oriented and can organize, prioritize.

• Strong problem-solving 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

• Manufacturing/Engineering experience preferred