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 s