Senior Director Laboratory System Development

Exact Sciences Redwood City , CA 94063

Posted 2 months ago

Summary of Major Responsibilities

Reporting to the VP of Technical Service & Support, the Senior Director, Laboratory System Development will lead the Process Engineering department, which includes Process Development, Process Validation, and Systems Engineering teams. This role will create, champion, and execute strategies to continually optimize the operational capabilities of the Exact Sciences Clinical Laboratory within our Precision Oncology Business Unit. These efforts will drive continuous improvement in scalability, efficiency, quality, cost, and business continuity.

The successful candidate will oversee this group's continuing pivotal role in creating robust, scalable cost-effective laboratory processes for ongoing use in commercial patient sample testing. The Senior Director, Laboratory System Development will implement best engineering management and organizational development practices as the number, complexity, and diversity of this group's projects continue to expand. These projects include the exploration, development, validation, and implementation of new and/or improved clinical diagnostic testing processes, and the investigation, root cause analysis, and resolution of issues that arise in this production laboratory environment. The Senior Director, Laboratory System Development will ensure alignment of this team's efforts with Exact Sciences strategic priorities, carefully balancing continuous process improvement efforts with new product development efforts conducted in partnership with our R&D team. This role will also ensure effective collaboration with the Service Engineering function, providing support for investigation of complex issues escalated by the Service Engineering team.

The Director, Laboratory System Development will foster and facilitate the professional growth and development of our engineering staff and will ensure effective cross-functional collaboration across the organization. This role will be accountable for building organizational capability within the team by recruiting and retaining outstanding talent and providing mentoring, training (internal and external), and other opportunities for professional growth and development. This role will drive continuous improvement in our operating mechanisms for managing, documenting, staffing, and reviewing laboratory improvement projects. The Director, Laboratory System Development will collaborate with other leaders in Clinical Laboratory Operations, other Operations groups, IT, R&D, and other functions to implement harmonized engineering change control and design control practices.

The ideal candidate will have extensive experience in successful direct management of experienced engineering leaders and teams engaged in the design, development, and continuous improvement of robust, scalable, high-throughput, and automated production processes for generation of genomic and/or genetic data for clinical diagnostic use. This role will have a track record of success in building expert, collaborative and inspired engineering organizations to consistently deliver the processes, technologies, and systems required for success.

Essential Duties and Responsibilities

  • Lead the Laboratory Process Engineer teams with direct management responsibility for the senior staff and primary accountability for ensuring this team has the technical and professional skills, capacity, and business processes needed to efficiently establish the laboratory processes, technologies, new products, and ongoing support required to achieve our strategic objectives.

  • Provide leadership in ongoing refinement of internal business processes for managing the exploration, development, validation, and implementation of improved laboratory patient sample testing technologies, workflows, and infrastructure, in a manner which appropriately balances rigor, speed, and flexibility.

  • Anticipate and plan for staffing, equipment, space, and other resources required to deliver on new product development, scalability improvements for existing products, and other critical and long-term growth initiatives.

  • Continually strengthen the capabilities of this group by developing, hiring, and mentoring the best available talent, including both managers and individual technical talent.

  • Develop capabilities within the department for process modeling to assess bottlenecks and limitations of current processes and quantify the impact of proposed improvements on labor efficiency, cost of goods, capacity, and other operational attributes.

  • Foster and facilitate effective cross-functional communication, alignment, collaboration, leadership and execution on project objectives, plans, and priorities with a broad variety of internal groups, including R&D, Biostatistics, Biomedical Data Computing, Information Technology, Business Development, Clinical Laboratory Operations, Service Engineers, Pathology, Reagent Manufacturing & Quality, Supply Chain, as well as with external development partners and suppliers.

  • Identify and leverage engineering best practices in designing new products and processes for robustness, scalability, industry-leading quality, and the efficient use of labor, equipment, consumables, budget and space; ensure insightful collection of business requirements, development of functional / engineering specifications and engineering designs, and creation of verification and validation plans.

  • Keep abreast of new technology developments in the market that may be adopted to solve internal lab process challenges.

  • Ensure responsive, collaborative and effective support of Exact Sciences' Clinical Laboratory and other operational functions in investigation, resolution, and prevention of issues with processes, equipment, reagents, and software used in commercial production.

  • Oversee effective communication, collaboration, and contract negotiation, with critical suppliers, engineering design and/or integration partners, and other external parties involved in the development, supply, and service of laboratory equipment, ensuring clarity and accountability on requirements, delivery dates, equipment specifications, acceptance testing plans, pricing, and post-installation service.

  • Support Business Development, R&D, Operations, and other groups as needed in evaluating technologies, partners, potential mergers / acquisitions by providing engineering input and perspective relevant to the strategic review and decision-making process.

  • Provide leadership in the management of Exact Sciences process- and technology-related intellectual property (IP), collaborating with our Legal Department, to ensure appropriate internal understanding and protection of our IP and evaluating non-GHI IP when necessary.

  • Excellent communication, collaboration, and leadership skills to ensure ongoing alignment between the Laboratory Process Engineering department, Senior Management, other internal functions, and key external partners, collaborators, and suppliers.

  • Ability to manage multiple process and/or automation technology development projects simultaneously, allocate resources and prioritize key deliverables to optimize delivery timelines while meeting all critical requirements.

  • Strong desire to work in a dynamic interdisciplinary team environment.

  • Demonstrated ability to foster and facilitate collaboration both within and across project teams and functional departments on projects requiring a wide variety of technical and non-technical disciplines.

  • Demonstrated ability to develop, evaluate, communicate, and execute strategies for internal development and external acquisition of technologies and processes which provide the operational capabilities required for our planned business growth.

  • Demonstrated success in contract negotiation with external engineering partners and management of outsourced engineering projects.

  • Able to integrate and apply feedback in a professional manner.

  • Other responsibilities as assigned.

  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.

  • Support and comply with the company's Quality Management System policies and procedures.

  • Regular and reliable attendance.

  • Standing or sitting for long periods of time may be necessary.

  • Some lifting (greater than 25 pounds) may be necessary.

  • A considerable amount of time using various types of laboratory equipment including microscopes, microtomes, blades, strainers, pipettes.

  • May perform repetitious actions using lab tools.

  • Some time spent using near vision to view samples at close range.

  • Use of various chemicals may be used to perform duties.

  • At times, stress may be experienced.

  • Use of computer and some time may be spent concentrating, reading, or analyzing data, or applying scientific rules.

  • May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating, and freezing elements, and high-speed centrifugation.

  • Ability to travel 10% of working time away from work location, may include overnight/weekend travel.


Minimum Qualifications

  • Bachelor's degree in a relevant engineering discipline.

  • 15+ years of relevant industrial engineering management experience. 10 + year track record of success in building strong engineering organizations with proven ability and enthusiasm to lead, hire, mentor, develop, retain, and inspire the best talent.

  • 15+ years of experience in electromechanical, software, optical, and other systems for use in process automation and control and understanding of best practices for development of these systems from concept to Clinical Laboratory implementation.

  • 15+ years of experience with technology transfer from development functions into the intended production environment, and between production groups or locations.

  • A track record of success in managing the design and development of robust, scalable, high-throughput automation solutions for complex production processes and/or equipment and instrumentation used in these processes, including best practice for managing designs, configurations, and a code base.

  • Demonstrated success in the use of continuous process improvement methodologies to optimize capacity, robustness, quality, cost, and other operational parameters.

  • Appropriate working knowledge of regulatory requirements to make sure the laboratory is in compliance with all applicable laws and regulations, including applicable CLIA, CAP, California, New York (CLEP), and other requirements.

  • Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

  • Laboratory automation system and development experiences.

  • Experience with process and technology development and ongoing production support within a high complexity, high throughput clinical laboratory operating under ISO 13485, ISO 15189, or similarly stringent quality management system.

  • Extensive knowledge and experience in current methods of genomic and genetic analysis including real-time PCR, next-generation DNA sequencing, and related methods.

  • Extensive knowledge and experience with liquid handling robotics, equipment, and analytical instrumentation used in these applications.

  • Prior experience in the fields of clinical diagnostics, medical devices, forensics, or other relevant regulated areas.

  • Prior experience developing and/or supporting a Clinical Laboratory conducting high-complexity clinical diagnostic tests.


We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company's affirmative action program are available to any applicant or employee for inspection upon request.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior System Integration Engineer (Validation)

Exact Sciences

Posted 2 weeks ago

VIEW JOBS 3/21/2020 12:00:00 AM 2020-06-19T00:00 Summary of Major Responsibilities Reporting to the Director of Process Validation, this Senior System Integration Engineer (Validation) will provide leadership and expertise in the validation of assay systems for the state-of-the-art clinical laboratory. The successful candidate will play an influential and leading role in ensuring that the assay systems and processes are installed, operate, and perform as specified; and capable of reliably and repeatedly producing products of the required quality. This position will also partner closely with Engineering and Quality Assurance to pilot new assay system processes that are compliant with the applicable regulations and standards. He/she will apply and advocate best practices in system integration and assay verification and validation, train the appropriate team members and identify opportunities for continuous improvement. Essential Duties and Responsibilities * Lead assay systems verification and validation in the clinical laboratory. * Develop strategies for system-level integration and testing; including assay reagents, consumables, hardware, and software. * Author, review and/or approve validation documentation (Validation Plans, Risk Assessments, Specifications, Protocols and Reports, Trace Matrices) and change controls for compliance with applicable business and regulatory requirements. * Support the development of user requirements, system requirements, system architecture and design, risk analysis, and usability engineering for new assay system introduction or process improvement. * Make data-driven decisions by designing experiments and collecting, analyzing, and presenting data results. * Enforce Good Documentation Practice (GDP) and Data Integrity. * Develop and communicate expectations for quality performance, continuous improvement, process controls infrastructure for critical sustaining parts and new products. * Operate a variety of laboratory instrumentation and simulators to perform assay system integration and functionality testing with new software and hardware. * Participate as the assay system Subject Matter Expert during internal and external audits/inspections. * Train others in the configuration, deployment, use and/or maintenance of assay system workflows. * Contribute to cross-functional efforts that ensure compliance with ISO13485, ISO15189, ISO 62304, and other domestic and international regulations and standards. * Demonstrated ability to lead cross-functional teams through the design, testing, and implementation of automation workflows. * Experience partnering with Development and Quality Assurance to build compliant workflows, processes, and procedures. * Demonstrate Systems Engineering best practices. * Skilled in identifying root cause and complex problem-solving. * Excellent interpersonal, written, and verbal communication skills. * Ability to work as part of a cross-functional team according to an established timeline. * Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. * Support and comply with the company's Quality Management System policies and procedures. * Regular and reliable attendance. Qualifications Minimum Qualifications * Ph.D. in engineering or science (preferably in bioengineering, biomedical engineering, chemical engineering, computer science, information systems, software engineering or a closely-related discipline); or MS in listed discipline and 5 years of experience in lieu of Ph.D.; or BS in listed discipline and 8 years of related experience in lieu of Ph.D. * 3 years of related work experience. * Knowledge of assay system design control and validation, particularly those related to automated laboratory instruments, in compliance with ISO13485, ISO 62304, ISO15389 or other similar standards. * Experience with standard molecular biology techniques for purification, quantitation, and amplification of nucleic acids. * Able to apply risk-based approach to testing strategies, for a more efficient and targeted validation effort. * GDP and data integrity enforcement experience. * Demonstrated ability to perform the Essential Duties of the position with or without accommodation. Preferred Qualifications * Experience programming automated laboratory instruments and/or systems, such as liquid handling robotics. * 5+ of experience working in medical devices/IVD. * Knowledge of TECAN EVOWare and/or Hamilton Venus scripting language. * Familiarity with CAP and/or CLIA regulations. * Project management skills or certification. #LI-SD1 We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company's affirmative action program are available to any applicant or employee for inspection upon request. Exact Sciences Redwood City CA

Senior Director Laboratory System Development

Exact Sciences