Manager, Process Development and Automation Job at Exact Sciences (Redwood City)

Job Description

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.

Job Responsibility

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
Effectively manage, support, and guide your team
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
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
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

Requirements

Bachelor's Degree in Engineering, Technology, Molecular Biology, Clinical Laboratory science, Chemical, biological, Electronics, or related field and 2 years’ experience as outlined in the essential duties
or Associates Degree in a Microbiology field or Engineering Science and 4 years’ experience as outlined in the essential duties in lieu of Bachelor's degree
2+ years in a role with progressively increasing responsibilities such as laboratory management, quality and control, lead technologist, or technical specialist
8+ years’ experience in process development, laboratory automation, service engineering, laboratory setting, or related industry as outlined in the essential duties
Successful track record of leading projects holistically from inception to successful implementation with cross-functional participation in a matrixed environment
Proficient in computer aided design software (SolidWorks) or statistical analysis programs (JMP), Microsoft Office Word, Excel, PowerPoint, and similar software
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
Experience in the design, development, and implementation of solutions comprised of integrated automated and manual workflows, including software components in a highly regulated environment (ISO 13485 or 21 CFR Part 820, or cGMP using 21 CFR Part 210, 21 CFR Part 211)
Understanding and application of user requirements, system requirements, risk assessments, trace matrices, FMEA, etc. translating into a successful track record in understanding complex end-user applications, collecting and clearly documenting end-user needs, and translating those into clear, concise, and testable requirements
1+ years in a leadership role with staff and team accountability
1+ years of experience with high complexity testing in a clinical laboratory setting includes laboratory automation and laboratory information system design and validation
Ability to travel up to 40% of working time away from work location, may include overnight/weekend travel
Demonstrated ability to perform the Essential Duties of the position with or without accommodation
Authorization to work in the United States without sponsorship

Nice to have

Prior experience developing and/or supporting a Clinical Laboratory conducting high-complexity clinical diagnostic tests
Experience in the Medical Device, Diagnostic and/or Life Science fields
Hands-on experience with Lean Six Sigma, e.g., SIPOC, VSM, 5S, Root Cause Analysis
Demonstrated ability to plan workload, allocate tasks, and scale operations to align with business priorities
4+ years’ experience leading and/or directing people and/or project teams
4+ years’ test method validation and development
4+ years’ work experience with LIS configuration and UAT verification

What we offer

Paid time off (including days for vacation, holidays, volunteering, and personal time)
Paid leave for parents and caregivers
A retirement savings plan
Wellness support
Health benefits including medical, prescription drug, dental, and vision coverage
Bonus eligibility

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Manager, Process Development and Automation

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