POSITION SUMMARY:
The Senior Director, Laboratory Operations is responsible for developing, planning, implementing, monitoring, and improving processes for new or existing products across multiple labs and locations to meet corporate goals. Works closely with quality groups including the accountable Clinical Laboratory Director to ensure strict compliance with approved policies and procedures at all times. Ensures the effective use of materials, equipment, and employees in producing quality products. Develops, monitors, and controls budgets for labor and capital expenditures.
Formulates and champions clinical testing policies, procedures, and programs to achieve quality, cost, revenue, and margin goals.
PRIMARY RESPONSIBILITIES:
- Reporting to the Vice President Laboratory Operations, this individual develops and provides strategy, vision and direction in close collaboration with other Laboratory Operations leaders.
- Responsible for championing operational needs and inspiring cross departmental support for implementation of simultaneous initiatives to improve quality, capacity, Turn Around Time (TAT), and COGS.
- Acts as the primary contact for delegated products, builds effective partnerships, and communicates succinct updates with departmental heads to help drive the business towards achieving company objectives.
- Responsible for contributing to budget preparation, monitoring of revenue, expenses, test volume, FTE utilization, report/result turnaround, as well as overall workflow, and customer and employee satisfaction.
- Leads, directs, and manages high performing teams with accountability for customer satisfaction of assigned departments and products.
- Oversees the development and achievement of departmental key performance indicators (KPI) through optimizing departmental performance and communicates effectively with key stakeholders
- Serves as a visible role model to drive continuous improvement, implements effective change management in support of changes, delegates work, and builds a strong leadership bench.
- Fosters a positive work environment by utilizing employment policies and procedures, awards, and other opportunities within the company. Serve as a role model for standards of behavior and performance.
- Ensures subordinate development through professional development reviews, coaching, mentoring and training. Collaborates with direct reports to create professional development goals for their team.
- Interacts with executive level management to influence internal and external policy-making.
- Responsible for representing the company during audits, visits, technical calls, and client visits.
QUALIFICATIONS:
- BS/BA degree (or equivalent) in STEM related field; Biological Sciences preferred
- A combination of education and experience equivalent to: Bachelor degree (BS) and 12+ years’ experience; Master’s degree (MS) and 10+ years’ experience; PhD and 7+ years’ experience.
- 5 plus years’ experience overseeing manufacturing at a Director or Senior Manager level
- Ability to travel up to 25%
- Current California CLS license or CGMBS license (Clinical Genetics Molecular Biology Scientist) preferred
KNOWLEDGE,SKILLS AND ABILITIES:
- Proven track record in successfully maintaining Quality program procedures, ISO 13485 standard, experience highly preferred
- Working knowledge of FDA requirements as per 42 CFR 493 (CLIA) and 21 CFR 820 (QSR)
- Working knowledge of Good Documentation Practices (GDP), and Good Clinical Practices (GCP) / Good Manufacturing Practices (cGMP), preferred
- Experience handling product/process nonconformities, audit corrective actions, and CAPAs.
- Excellent computer skills, including Microsoft Office Suite (especially Excel)
- Excellent communication skills with managers, subordinates, and colleagues with a proven track record to influence change (written and oral)
- Exceptional level of organization, time management, problem solving, self-motivation and reliability
- Experience in building and managing a high performing group of engaged and motivated employees
- Track record of providing succinct, timely, and thorough program updates to leadership
- Knowledge and experience with Lean Six Sigma concept and tools, manufacturing/Engineering experience, and LDT laboratory operations required.
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.Austin, TX$183,936—$229,920 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
