Associate Director, Laboratory Operations- TiH

Natera; Austin (TX); On-site; USD 132,000 - 165,000; Full time

Benefits offered by this job

Medical benefits

401k benefits

Fertility care benefits

Paid time off

Job summary

Natera in Austin, TX is seeking an Associate Director, Laboratory Operations to lead manufacturing methods, processes, and operations for new and existing products. The role ensures CLIA/CAP and HIPAA compliance while optimizing the use of materials, equipment, and staff.

You will develop budgets, KPI dashboards, and mentor teams to improve production performance across the lab. Collaboration with senior leadership and cross-functional teams is required to drive company objectives.

Qualifications

• BS/BA degree in STEM-related field; Biological Sciences preferred.
• At least 8 years’ experience and with at least 5 years’ experience overseeing manufacturing or a CRO production team at a leadership level

Responsibilities

• Provide operational and strategic leadership to laboratory products assigned to the individual.
• Participate in budget preparation, monitoring of revenue, expenses, test volume, FTE efficiency, and production performance.
• Ensure compliance with all regulatory and legal parameters.
• Lead and manage high performance teams with accountability for operations, quality, and customer service.
• Draft SOWs and process select research samples through the CLIA lab; oversee method validation and transfer.
• Develop KPIs and analyze opportunities to optimize department performance.
• Direct production laboratory personnel in manufacturing activities including method validation and in-process testing.
• Develop or oversee lab production processes and procedures; authorize implementation.
• Mentor staff through development reviews, coaching, and training.
• Collaborate with direct reports to set professional development goals and foster a positive environment.
• Provide executive level production summaries.
• Represent the company during audits, visits, and client calls.
• Build partnerships with department heads to drive business objectives.
• Set objectives and schedules; delegate as needed.
• Engage with senior management regularly; work with PHI on a regular basis.
• Complete HIPAA/PHI privacy and compliance training within 30 days of hire.
• Maintain current status on Natera training requirements.
• Perform other duties as assigned.

Skills

Leadership

Budgeting

Regulatory compliance

GxP

HIPAA/PHI awareness

Communication

Project management

Team building

Education

BS/BA in STEM

Tools

Microsoft Office Suite

Google Workspace

Job description

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 ProcedureCompliancetraining and security training as soon as possible but not later than the first 30days 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

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.

Austin, TX

$132,000—$165,000 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.comemail 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