POSITION SUMMARY:

The Associate Director, Laboratory Operations a key leader in Natera’s lab operations who oversees and directs the development, planning, implementation and maintenance of manufacturing methods, processes and operations for new or existing products and technologies. The AD works closely with groups to ensure strict compliance with good manufacturing practices and CLIA/CAP guidelines at all times. Ensures the effective use of materials, equipment and employees in producing quality products. Monitor and control staffing / labor, capital expenditures, and manufacturing performance. Develops budget and monitors expenditures. Formulates and recommends manufacturing policies, procedures and programs. Selects, develops and evaluates line-management to ensure the efficient operation of the function.

PRIMARY RESPONSIBILITIES:  

• Under direction of Senior Director, and in close collaboration with other Laboratory leadership, this individual provides operational and strategic leadership to laboratory products assigned to the individual.

• Participates in budget preparation, monitoring of revenue, expenses, test volume, FTE efficiency, report/result turnaround, as well as overall production performance.

• Responsible for compliance with all regulatory and legal parameters. 

• Serves as a model for standards and behavior performance.

• Participate in the drafting of SOW and processing of select research samples through the CLIA lab. Leads, directs and manages high performance teams with accountability for operations, quality, customer service, and success of assigned departments and product lines.

• Identifies and champions development of departmental key performance indicators (KPI) and analyze for opportunities to optimize department performance.

• Directs Production Laboratory personal in support of activities for manufacturing that will include method validation, method transfer, and in-process testing.

• Develops or oversees the development of Laboratory production process, procedures, and authorize the implementation.

• Develops subordinate’s development through professional development reviews, coaching, mentoring, and training. 

• Collaborates with direct reports to create a professional development goals for his/her team and fosters a positive work environment.

• Generates and routinely provide executive level production/departmental summaries.

• Responsible for representing the company during audits, visits, and technical and client calls.

• Builds effective partnerships with department heads to help drive the business toward achieving company objectives.

• Establishes operational objectives and plans.

• Delegate assignments as necessary.

• Works on issues where analysis requires in-depth knowledge of organizational objectives. Establishes schedules, work plans, and performance requirements.

• Interacts regularly with senior management or executive levels.

• This role works with PHI on a regular basis both in paper and electronic form and have 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.

• Performs other duties as assigned.

QUALIFICATIONS:  

• BS/BA degree (or equivalent) in STEM-related field; Biological Sciences preferred

• At least 8 years’ experience and with at least 5 years’ experience overseeing manufacturing or a Contract Research Organization production team at a leadership level

• Prefer to have ASCP MLS certification or ability to obtain ASCP MLS certification

KNOWLEDGE, SKILLS, AND ABILITIES:

• Experience managing a CLIA/CAP CRO production team is highly preferred Proficiency with Microsoft Office Suite (Word, PowerPoint, Excel) and Google products (Gmail/GCal/Drive/GChat). Excellent oral and written communication skills, strong organization skills and high attention to detail.

• Aptitude to thrive in fast paced unstructured, constantly changing environment when faced with multiple challenging projects Strong interpersonal skills with a service-oriented mindset.

• Proactive, independent self-started with a can-do attitude.

• Establish and maintain positive and effective working relationships with clients, coworkers, contractors, and vendors.

• Strong detail orientation: ability to set priorities, multi-task and meet deadlines

• Ability to work effectively with technical employees at all levels.

• Ability to handle sensitive, confidential information discreetly and professionally.

• Experience in Molecular Biology.

• Experience in building and managing a high performing group of engaged and motivated employees

POSITION SUMMARY

The Clinical Lab Supervisor is a leader in Natera’s lab operations whose role is to oversee employees' performance and serve as a liaison between employees and senior management to meet company goals and quality objectives. The supervisor is responsible for daily supervision of lab staff performing duties such as laboratory testing and data review. Duties include but are not limited to coaching, motivating, staffing, evaluating, and training staff. The supervisor works closely with the manager to ensure company and team goals are met while adhering to good manufacturing practices and CLIA/CAP guidelines.

PRIMARY RESPONSIBILITIES

• Responsible for day-to-day staffing/scheduling/setting up sample run schedules.

• Ensures production work is consistently completed according to department goals.

• Ensures all case samples are processed and accounted for.

• Monitors team members to ensure adherence to SOPs and safety procedures

• Oversees training for new hires: works in conjunction with lead to train new hires.

• Document nonconformance reports and all corrective actions taken when test systems deviate from the established performance specifications as needed. Escalates protocol deviation to lead/supervisor.

• Assists manager in initiating and completing CAPAs.

• Handles employee issues. Collaborates with Manager and/or Human Resources to resolve issues.

• Ensures alignment with team for reasoning behind instructions/processes and changes

• Meets regularly with individual team members to discuss goals and progress.

• Responsible for staff performance reviews.

• Plans and leads shift meetings

• Maintains team morale and professionalism of team members, including by acting as role model.

• Adheres to Departmental Expectations

• Ensures compliance with all regulatory agency requirements through documentation, audits, and corrective action.

• Go-to person when manager is not present.

• May assist lab team in day to day tasks

• Keeps team morale up and maintains professionalism of team members, including by acting as role model.

• Assists the team in day to day lab work if necessary.

• Approves timecards and PTO requests

• Escalates lab issues and team concerns to manager. Communicates the problem and suggests possible solutions.

• Understands the entire lab process and can identify and troubleshoot issues when they arise.

• Understands when and how to escalate issues appropriately.

• Makes sure the goals set by manager for the team are being met in the lab.

• Performs and completes side projects assigned by the manager.

• Actively interacts with interdepartmental teams such as OPS, Accessioning, Engineering, Stats, R&D, and Support.

• Receives assignments in the form of objectives with goals and the process by which to meet goals.

• Provides direction to employees according to established policies and management guidance.

• Administers company policies that directly affect subordinate employees.

• Recommends changes to unit or sub-unit policies.

• Provides direct supervision to professional individual contributors and/or skilled, support individual contributors

• Acts as advisor to unit or sub-units and may become actively involved, as required, to meet schedules and resolve problems.

• This role works with PHI on a regular basis both in paper and electronic form and have 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.

• Performs other duties as assigned.

QUALIFICATIONS

• BS/BA degree (or equivalent) in Medical Technology program with 4 years CLIA laboratory experience

• BS/BA, Physical, Chemical or Biological Sciences, or a related field 5 years experience in a CLIA laboratory 

• Master’s degree in arts or science with a major in chemical, physical or biological sciences with 3 years experience in a CLIA laboratory 

• Master’s degree with BS/BA in Medical Technology program with 2 years experience in a CLIA laboratory 

• Current MT/MLS/CLS/MB/MDx certification from ASCP, AMT, or AAB required.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Proven leadership experience

• Able to take on projects with little supervision.

• Excellent interpersonal, communication, computer, troubleshooting, and pipetting skills.

• Experience in Molecular Biology

• Excellent oral and written communication skills.

• Word processing and data management skills.

POSITION SUMMARY:

The Associate Director, Laboratory Operations a key leader in Natera’s lab operations who oversees and directs the development, planning, implementation and maintenance of manufacturing methods, processes and operations for new or existing products and technologies. The AD works closely with groups to ensure strict compliance with good manufacturing practices and CLIA/CAP guidelines at all times. Ensures the effective use of materials, equipment and employees in producing quality products. Monitor and control staffing / labor, capital expenditures, and manufacturing performance. Develops budget and monitors expenditures. Formulates and recommends manufacturing policies, procedures and programs. Selects, develops and evaluates line-management to ensure the efficient operation of the function.

PRIMARY RESPONSIBILITIES:  

• Under direction of Senior Director, and in close collaboration with other Laboratory leadership, this individual provides operational and strategic leadership to laboratory products assigned to the individual.

• Participates in budget preparation, monitoring of revenue, expenses, test volume, FTE efficiency, report/result turnaround, as well as overall production performance.

• Responsible for compliance with all regulatory and legal parameters. 

• Serves as a model for standards and behavior performance.

• Participate in the drafting of SOW and processing of select research samples through the CLIA lab. Leads, directs and manages high performance teams with accountability for operations, quality, customer service, and success of assigned departments and product lines.

• Identifies and champions development of departmental key performance indicators (KPI) and analyze for opportunities to optimize department performance.

• Directs Production Laboratory personal in support of activities for manufacturing that will include method validation, method transfer, and in-process testing.

• Develops or oversees the development of Laboratory production process, procedures, and authorize the implementation.

• Develops subordinate’s development through professional development reviews, coaching, mentoring, and training. 

• Collaborates with direct reports to create a professional development goals for his/her team and fosters a positive work environment.

• Generates and routinely provide executive level production/departmental summaries.

• Responsible for representing the company during audits, visits, and technical and client calls.

• Builds effective partnerships with department heads to help drive the business toward achieving company objectives.

• Establishes operational objectives and plans.

• Delegate assignments as necessary.

• Works on issues where analysis requires in-depth knowledge of organizational objectives. Establishes schedules, work plans, and performance requirements.

• Interacts regularly with senior management or executive levels.

• This role works with PHI on a regular basis both in paper and electronic form and have 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.

• Performs other duties as assigned.

QUALIFICATIONS:  

• BS/BA degree (or equivalent) in STEM-related field; Biological Sciences preferred

• At least 8 years’ experience and with at least 5 years’ experience overseeing manufacturing or a Contract Research Organization production team at a leadership level

KNOWLEDGE, SKILLS, AND ABILITIES:

• Experience managing a CLIA/CAP CRO production team is highly preferred Proficiency with Microsoft Office Suite (Word, PowerPoint, Excel) and Google products (Gmail/GCal/Drive/GChat). Excellent oral and written communication skills, strong organization skills and high attention to detail.

• Aptitude to thrive in fast paced unstructured, constantly changing environment when faced with multiple challenging projects Strong interpersonal skills with a service-oriented mindset.

• Proactive, independent self-started with a can-do attitude.

• Establish and maintain positive and effective working relationships with clients, coworkers, contractors, and vendors.

• Strong detail orientation: ability to set priorities, multi-task and meet deadlines

• Ability to work effectively with technical employees at all levels.

• Ability to handle sensitive, confidential information discreetly and professionally.

• Experience in Molecular Biology.

• Experience in building and managing a high performing group of engaged and motivated employees