Associate Director, Laboratory Operations- Sig CLIA/CTA

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