Director, Laboratory Operations
Location: San Carlos
Posted on: October 12, 2018
POSITION SUMMARY: The Director, Laboratory Operations oversees and directs the development, planning, implementation and maintenance of manufacturing methods, processes and operations for new or existing products and technologies. Works closely with quality groups to ensure strict compliance with good manufacturing practices guidelines at all times. Ensures the effective use of materials, equipment and employees in producing quality products. Monitor and control labor and capital expenditures. 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 the Vice President Laboratory Operations, and in close collaboration with other Laboratory Operations Directors, this individual provides operational and strategic leadership to Laboratory Services. * Responsible for budget preparation, monitoring of revenue, expenses, test volume, and FTE utilization, report/result turnaround, as well as overall workflow, and customer and employee satisfaction. * Responsible for compliance with all regulatory and legal parameters. Serve as a role model for standards of behavior and performance. * Leads, directs and manages high performance teams with accountability for operations, quality, customer service, and success of assigned departments and product lines. * Oversees the development of departmental key performance indicators (KPI) and analyze for opportunities to optimize department performance. * Directs Production Laboratory Mangers in support of activities for manufacturing that will include method validation, method transfer, and in-process testing. * May provide scientific leadership in the generation of all batch release data and final product disposition. * Oversees the development of Laboratory Production policies and authorizes the implementation of these policies. * Facilitates the resolution of organizational obstacles encountered. * Fosters a positive work environment by utilizing employment policies and procedures, awards, and other opportunities within the company. * Develops subordinate's development through professional development reviews, coaching, mentoring, and training. Collaborates with direct reports to create professional development goals for his/her team. * Interacts with executive level management to influence policymaking both internally and externally. * Responsible for representing the company during audits, visits, and technical calls and client visits. * Builds effective partnerships with department heads to help drive the business toward achieving company objectives QUALIFICATIONS: * BS/BA degree (or equivalent) in STEM related field; Biological Sciences preferred * A combination of education and experience equivalent to: Bachelor's degree (BS) and 10-15 years' experience; Master's degree (MS) and 7-9 years' experience; PhD and 4-6 years' experience * 5 plus years' experience overseeing manufacturing at a Director or Senior Manager level KNOWLEDGE, SKILLS, AND ABILITIES: * Proven track record in successfully maintaining Quality program procedures, ISO 9000 standards series, experience highly preferred * Working knowledge of FDA requirements as per 42 CFR 493 (CLIA) and 21 CFR 820 (QSR) * Working knowledge of Good Documentation Practices (GDP), and Good Laboratory Practices (GLP) / Good Manufacturing Practices (cGMP), preferred * Excellent computer skills. Proficient with Microsoft Office Suite (especially Excel) * Excellent communication skills (written and oral) * Exceptional level of organization, time management, problem solving, self-motivation and reliability * Experience in building and managing a high performing group of engaged and motivated employees * Knowledge and experience with Lean Six Sigma concept and tools * Manufacturing/Engineering experience, Laboratory Operation, preferred PHYSICAL DEMANDS & WORK ENVIRONMENT: * Duties typically performed in an office setting * Must be able to sit or stand for long periods of time * Duties may require working weekends Travel required for this position: * No ? or Yes ? : If yes state anticipated percent for travel: 0SDL2017
Keywords: Natera, San Francisco , Director, Laboratory Operations, Executive , San Carlos, California
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