Manager, Process Development & Automation

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At Exact Sciences, we're helping change how the world prevents, detects, and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working to help others.

Position Overview

The Manager, Process Development and Automation provides leadership support to the Process Development and Automation staff, with expertise in systems integration, workflow automation, and building strong partnerships with Laboratory Operations as our primary internal customer. This role leads a team responsible for systems design, validation, and implementation across integrated automated and manual workflows. The position emphasizes driving high value project success through collaborative partnerships with Laboratory Operations and cross-functional teams while consistently meeting timelines and exceeding Lab Operations expectations.

This position is primarily responsible for supervision, leading, training, and mentoring Process Development and Automation team members whose work delivers innovative solutions that optimize laboratory processes through advanced hardware / software interfacing, automation systems integration, and comprehensive workflow optimization. The role requires demonstrated expertise in leading technical initiatives, actively listening to Laboratory Operation's needs, ensuring the team translates complex user requirements into detailed specifications, and delivering strategic initiatives that address key customer priorities while ensuring rigorous compliance with ISO standards and regulatory requirements (including CFR 21, ISO 13485) in a highly regulated environment. The successful candidate will have proven leadership experience executing complex projects with minimal errors, mentoring junior staff, and providing guidance that elevates team performance and customer satisfaction.

Essential Duties

Include but are not limited to the following :

• Provide leadership on best practices for the development of processes and products in a regulated environment.
• Lead the team in continuous improvement projects and support other areas' needs dependent on demand.
• Coach, mentor, and raise the team's ability to deliver and exceed expectations while creating opportunities for team member development.
• Consistent demonstration of exceptional leadership qualities, including but not limited to the ability to attract and retain the best team, foster a culture of high performance, lead with integrity, humility, accountability, and courage, and set a clear vision to energize teams towards the future.
• Effectively manage, support, and guide your team, including, but not limited to delegating tasks and responsibilities, assess employee performance and provide helpful feedback and training opportunities.
• Serve as a resource for employees by sharing and knowledge transfer of best practices for experiment design and execution.
• Ensure that any incoming support requests from outside of the normal channels are properly routed to ensure they are assigned and actively addressed.
• Ensure that assigned support requests from cross-functional project teams or business units are being actively addressed.
• Assist and coordinate training methodology and training documentation in conjunction with other leadership.
• Provide mentoring and technical guidance to PDA engineers and scientists.
• Serve as the primary source of contact for PDA engineers or scientists and oversee day-to-day PDA engineer and scientist's functionality.
• Work closely with instrument and automation support, technical service, and sustaining teams to provide design and service requirements and potential operational improvements.
• Support and comply with the company's Quality Management System policies and procedures.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Collaborate with multiple teams to determine root cause for production failures and works closely with technical services team to resolve issues.
• Identify and understand regulatory requirements to make sure the laboratory is in compliance with all applicable laws and regulations pertinent to the management of the laboratory, including applicable CLIA, CAP and other requirements and regulations such as California and New York (CLEP) laboratory programs."
• Maintain oversight for quality of mechanical work performed and of appropriate documentation.
• Provide information and suggestions to the appropriate resource(s) to improve company technical documentation and / or processes.
• Recommend and implement changes to ensure ongoing high-quality performance of laboratory processes.
• Maintain and continuously develop personal knowledge and expertise related to the design of complex laboratory equipment.
• Develop and lead the issue escalation process when instrumentation issues arise.
• Provide feedback on the effectiveness of training for new employees, training methodology, and training documentation in conjunction with leadership.
• Ensure ample coverage for day-to-day workload needs and recommend approval or rejection of requested time off.
• Apply Robust Design / Design for Six Sigma principles to the development of solutions.
• Serve as a subject matter expert on assay workflows, providing expertise in this area to colleagues.
• Ability to communicate ideas, opinions, and arguments in a proactive and professional manner.
• Ability to maintain excellent communication, documentation, and teamwork.
• Ability to be adaptable and open to change; ability to work in ambiguous situations and respond to new information and unexpected circumstances.
• Ability to successfully collaborate with colleagues and customers from a wide variety of scientific, engineering, operational, and regulatory disciplines across the organization at many different levels.
• Ability to lead cross-functional teams across different operations within the organization.
• Apply strong interpersonal and teamwork skills; ability to easily convey concepts and priorities, as well as ability to solicit feedback and inputs across all levels of the organization.
• Ability to effectively prioritize and delegate tasks.
• Ability to be self-motivated and reliable; ability to stay focused on a task and work independently.
• Critical thinking skills, along with high attention to detail, are required to plan and prioritize project activities for maximum leverage, impact, and return on investment.
• Ability to work seated for approximately 60% of a typical working day. Ability to work standing for approximately 40% of a typical working day.
• Ability to work on a mobile device, tablet, or in front of a computer screen and / or perform typing for approximately 90% of a typical working day.
• Excellent attention to detail and meticulous record keeping.

Minimum Qualifications

Preferred Qualifications