JOB DESCRIPTION:Position OverviewThe Product Development and Automation Senior Scientist provides services of a technical nature to support the development, implementation, and maintenance of automation, IT, and software systems used in the clinical laboratory. The Product Development and Automation Senior Scientist will perform moderate and highly complex analytical processes to support feasibility and validation studies. This includes wet lab testing for feasibility, verification and validation of lab automation, workflow, and software. This role will also be responsible for performing user acceptance testing (UAT), and validation of Laboratory information system (LIS) system changes and upgrades. This role will collaborate with end users and LIS developers to address needed improvements to current modules, design requirements for new test systems, validation, and implementation of the changes. Once resources are identified, can get a project off the ground and running with minimal support from management. Can make new processes, systems, validation methods or projects successful.
Essential DutiesInclude, but are not limited to, the following:
- Assist in UAT testing
- Edit and review controlled documents within the laboratory document control system to support changes or implementation of software and process changes.
- Contributes ideas and insights to new technologies, testing methodologies, applications, techniques or procedures that are creative and practical. Provides input for project design & development.
- Accurately estimates task effort, including work by others.
- Develops process architectures and functional specifications based on user and workflow requirements. Leads planning activities and conducts complex scientific design, platform eligibility testing, systems integration, or performance testing.
- Makes decisions that involve the consideration of complex issues.
- Works autonomously and checks-in as decisions are made.
- Responds to change with flexibility and adapts quickly.
- Discusses and presents factual information to other members of the same organization; Ability to convey very complex information in both written and oral form. Actively and constructively contributes to other's designs through design reviews within same organization.
- Facilitates reuse by communicating available technologies and opportunities within the organization.
- Able to influence others and gain acceptance and build consensus.
- Ability to manage moderately complex projects and initiatives, typically within one platform or business organization.
- Acts as a mentor / role model for junior team members on technical issues.
- Ability to apply project leadership skills in planning, delegating, influencing, and managing priorities.
- Beginning to demonstrate leadership behaviors: humility, will, best team and vision
- Demonstrates understanding of company's internal and external customer needs and how they affect business unit products and services.
- Brings company and industry knowledge as well as creative technical/scientific skills to product creation; recognized as a content, sub-discipline specialist across the company.
- Work with training teams to ensure timely and effective process change implementation in the laboratories.
- Perform moderate and/or highly complex analytic processes, without direct supervision.
- Evaluate data to calculate statistics for assessment of current and new processes.
- Work with all the laboratory management teams as a mentor throughout all the implementation stages, such as scoping, planning, implementing, and maintaining.
- Suggest cost-effective laboratory procedures or protocol changes.
- Implement changes in response to new technology and laboratory procedures; recommend and implement changes to ensure ongoing high-quality performance of laboratory processes, as assigned.
- Maintain all records and follow procedures to meet regulatory requirements such as FDA, CLIA, and/or CAP.
- Ability to work cross-functionally across different operations within the organization.
- Make decisions analytically, without direct supervision.
- Ability to think strategically, especially in relation to long term impacts of systems and processes.
- Excellent verbal and written English communication skills.
- Ability to define problems, collect data, establish facts, and draw valid conclusion
- Must be highly motivated and able to work both independently and as a member of a team.
- Adaptable, open to change and able to work in ambiguous situations and respond to new information and unexpected circumstances.
- Effectively communicate issues/problems and results that impact timelines, accuracy, and reliability of data.
- Ability to make recommendations from data analysis.
- 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.
- Ability to work designated schedule.
- Ability to lift up to 50 pounds for approximately 10% of a typical working day.
- Ability to work seated for approximately 80% of a typical working day. Ability to work standing for approximately 20% 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 80% of a typical working day.
- Ability to comply with any applicable personal protective equipment requirements.
- Ability to travel 5% of working time away from work location, may include overnight/weekend travel.
Minimum Qualifications- Bachelor's Degree in Clinical Laboratory Science, Medical Technology, or a relevant Chemical or Biological Science field.
- 6+ years of relevant work experience in a clinical laboratory.
- 1+ years of work experience with LIS configuration and UAT verification.
- Strong working knowledge of clinical laboratory operations and activities.
- Demonstrated ability to lead project work effectively in team situations as well as work independently.
- Demonstrated ability to follow procedures and maintain detailed records.
- Demonstrated ability to manage time and competing priorities.
- Demonstrated ability to take scientific bench protocols from the bench to automation system.
- Demonstrated ability to multi-task and work productively in a demanding environment with changing priorities while displaying a wide degree of creativity and latitude.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
- Authorization to work in the United States without sponsorship.
Preferred Qualifications- American Society for Clinical Pathology (ASCP) or equivalent certification.
- 1+ years of experience integrating laboratory information management systems (LIMS) with automated systems.
- 9+ years relevant experience
- 3+ coaching
The base pay for this position is $78,000.00 - $156,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Manufacturing
DIVISION:ONCO Cancer Diagnostics
LOCATION:United States > Madison : 1 Exact Lane
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 10 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)
