Manager, CLS at Natera

San Carlos, California, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Mar, 26

Salary

165000.0

Posted On

06 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Leadership, Compliance, Budget Management, Quality Control, Problem Solving, Team Management, Process Improvement, Communication, Organizational Skills, Lean Six Sigma, Manufacturing, Clinical Lab Operations, Data Analysis, Employee Development, Training Management, Performance Review

Industry

Biotechnology Research

Description

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. Shift timings are from 10.00 PM- 6.30 AM 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 The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations. San Carlos, CA $123,400—$165,000 USD OUR OPPORTUNITY 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. WHAT WE OFFER Competitive Benefits - Employee benefits include 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! For more information, visit www.natera.com. 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. If you are based in California, we encourage you to read this important information for California residents. Link: https://www.natera.com/notice-of-data-collection-california-residents/ Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes. For more information: - BBB announcement on job scams - FBI Cyber Crime resource page

Responsibilities

The Manager, Clinical Lab oversees lab operations, ensuring compliance with manufacturing practices and regulatory guidelines while managing staffing and production goals. They also engage in strategic planning and continuous improvement projects to enhance lab processes.