Manager, Process Development and Automation

Exact Sciences • Madison, WI

2d • Onsite

About The Position

The Manager, Process Development and Automation provides leadership support to the Process Development and Automation staff. This role is the point person for systems design, validation, and implementation. This position is primarily responsible for supervision, leading, training, and assisting Process Development and Automation team members.

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 Haves

• 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.

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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager