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Exact Sciences · 1 week ago

Manager, Process Development & Automation

Redwood City, CA

Full-time

Onsite

Senior Level, Lead/Staff

$124K/yr - $200K/yr

8+ years exp

Exact Sciences is helping change how the world prevents, detects and guides treatment for cancer. The Manager, Process Development and Automation provides leadership support to a team, focusing on systems integration and workflow automation while ensuring compliance with regulatory standards.

BiotechnologyHealth DiagnosticsManufacturingMedical

No H1B

Responsibilities

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

Qualification

Process DevelopmentLaboratory AutomationSystems IntegrationRegulatory ComplianceLean Six SigmaStatistical AnalysisProject ManagementTechnical LeadershipTeam CollaborationCommunication SkillsMentoringCritical Thinking

Required

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