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, and 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, or 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.