Supervisor, Lab Development And Technology Transfer

The Supervisor of the Lab Development and Technology Transfer team will oversee the equipment development projects and technology transfers activities within the production laboratories. The supervisor will oversee a team of scientists and lab technicians to support varied activities to implement and support equipment introduction for new projects, workflows, and/or improved capabilities. This work includes the support of Validation and Verification activities, as well as creation of all associated documentation -- Commissioning and Qualification (IQOQPQ), Maintenance Protocols, and Process Validation (PV) -- in support of technology transfer and new technology introduction to Natera's labs. Works closely with management to ensure projects are completed on time, within budget, and meet quality standards. The ideal candidate is a creative problem solver with strong leadership skills and a passion for innovation and continuous improvement.
PRIMARY RESPONSIBILITIES:
* Supervise, mentor, and develop a diverse team of scientists, instrument engineers and lab technicians. Responsible for day-to-day staffing, including hiring/training of personnel, and scheduling of work/projects.
* Meets regularly with individual team members to discuss individual development goals and project progress.
* Foster a collaborative and innovative team environment to maintain expertise as necessary to stay abreast of technical and industry advancements.
* Plan, execute, and oversee projects from development phase to production transfer.
* Manage the development and implementation of novel approaches to solving complex technical problems while maintaining required levels of safety, quality (including compliance), and production.
* Ensure projects are completed within predetermined timelines, financial forecasts, and meet quality standards.
* Prepare change control documentation, including protocols, summary reports, etc., for all activities.
* Implement and maintain life cycle documentations (IQOQPQ) for production equipment, automation systems, and processes to ensure all products meet company and regulatory requirements.
* Collaborate with the cross-functional team and communicate effectively with management, stakeholders, and regulatory agencies
* Work closely with other departments, including Engineering, Service, Lab Operations, Facilities and Procurement, to ensure successful product launches.
* Provide support to Service and Engineering teams to ensure the validated equipment maintains the validated state throughout its life cycle, utilizing troubleshooting experience/analysis of performance data to guide identification of the root cause of any failures to implement fixed resolutions.
* Communicate project status, risks, and opportunities to senior management.
* Identify opportunities for innovation and improvement of processes to optimize efficiency in the product line.
* Ensures compliance with all regulatory agency requirements through documentation, audits, and corrective action.
* Provides direction to employees according to established policies and management guidance; administer company policies that directly affect employees.
* Perform other duties as assigned.
* Adherence to CLIA/CAP/ISO13485 regulations as it pertains to instrumentation and equipment.
* This role works with PHI on a regular basis both in paper and electronic form and has 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.
* Must maintain a current status on Natera training requirements.
QUALIFICATIONS:
* Bachelor's degree in Engineering / Science /Technology Transfer / Development/ Business or related field
* 4+ years of industry related experience in equipment/product development, with at least 2 years in a leadership role.
* Proven track record of successfully managing product development projects.
KNOWLEDGE, SKILLS AND ABILITIES
* Strong leadership, team management, and interpersonal skills
* Must have good technical writing and strong oral and written communication skills
* Experience with project management and product lifecycle management software and tools
* Creative thinking and problem-solving abilities
* Adaptability in a frequently changing environment
* Maintain a high level of professionalism and responsibility
* Word processing and data management skills
* Understanding of essential molecular biology methods such as PCR, nucleic acid purification, gel electrophoresis, analysis tools and instrumentation, DNA quantitation, and quality control and proficiency working liquid handling automation and sequencer laboratory equipment preferred
* Knowledge of industry regulations and quality standards.
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
$106,193-$125,000 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