Manager Process Devlopment

Natera•5h ago

United StatesOnsite$141.6K–$177KFull-timeManager Level6+ yrs exp

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The Manager, Process Development will oversee tech transfers, process improvements and best practice development for Extractions Lab. The manager helps set priorities and defines necessary resources in cooperation with the Director, Extractions Operations. They will manage a direct team that coordinates change control, documents updates
necessary interactions with stakeholders on other Natera teams. Primary Responsibilities:
Receive guidance from senior management on company objectives for Extractions and help organize resources to meet those objectives.
Design the form and content of documents pertaining to Extractions procedures. Recommend changes as necessary to improve usability and accuracy.
Will direct and manage a team with accountability for operations, quality, service and success of assigned projects/product lines.
Identify opportunities for process and workflow improvements and direct projects to implement these improvements.
Represent the needs and concerns of Extraction teams in product launches.
Interact with engineering, equipment, quality, regulatory and other stakeholders to secure resources and coordinate on specific tasks
Develops subordinate’s development through reviews, coaching, mentoring and training. Collaborates with direct reports to create professional development goals for team.
Perform other duties as assigned.
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. Qualification Ph.D in Molecular Biology or related field
equivalent At least 6 years of industry experience in genetic testing or a related field Previous management experience required. Previous experience with assay development and/or QC strongly desired. CLIA/FDA laboratory support experience strongly desired. Knowledge, Skills and Abilities
Experience working in a regulated environment (GMP, ISO, CLIA, CAP, FDA)
Extensive experience mentoring/managing a diverse group of laboratory personnel with mixed technical background
Strong technical expertise in molecular biology and NGS-based laboratory assays
Extensive design, troubleshooting and diagnostic experience with molecular assays
Proven track record of successful projects that increase efficiency, improve quality, and reduce cost
Experience with formal quality management systems desired
Experience with development and documentation of standard operating procedures.
Excellent communication and interpersonal skills
Problem analysis and resolution abilities
Ability to prioritize responsibilities in a fast-paced environment. Physical Demand and Work environment
Day Shift but may include weekends
Duties may require working outside normal working hours (evenings and weekends) at times.
Duties are typically performed both in a laboratory or office setting.
The ability to use a computer keyboard, communicates over the telephone, and use laboratory equipment.
Must be able to lift up to 20 pounds. Compensation & Total Rewards This range reflects a good-faith estimate of the base pay we reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and internal equity considerations. This position is also eligible for additional compensation and benefits through Natera’s robust Total Rewards program, including: Annual performance incentive bonus Long-term equity awards Comprehensive health benefits (medical, dental, vision) 401(k) with company match Generous paid time off and company holidays Additional wellness and work-life benefits Compensation Range $141,636 &mdash
$177,045 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:
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Required skills

Molecular BiologyNGSGMPISOCLIACAPFDAAssay DevelopmentQuality ControlProject ManagementStandard Operating Procedures