Associate Product Support Scientist

Thornton Tomasetti; Madison (WI); On-site; USD 51,000 - 101,000; Full time

Job summary

Abbott in Madison, WI is hiring a laboratory scientist to provide technical and product support to Operations, perform investigations of OOS/NCMR/CAPA, and assist with assay development and validation readiness.

The role requires a life sciences degree, 2+ years in the field, proficiency with MS Office, and experience with PCR/qPCR, sequencing, and lab instrumentation; occasional travel may be required; strong collaboration across Quality, R&D, Regulatory Affairs.

Qualifications

• Bachelor’s degree in life sciences or related field.
• 2+ years of experience in the life sciences industry.
• MS Office proficiency (Word, Excel, Outlook, PowerPoint).
• Master’s or Doctoral degrees may be considered in lieu of 2 years of experience.

Responsibilities

• Provide technical and product support to Operations across cross-functional teams.
• Perform investigations of Out of Specification events (OOS), non-conformances (NCMRs), CAPA actions; conduct root cause analysis.

Skills

MS Office

Life sciences experience

Statistical analysis software

Education

Bachelor’s degree in life sciences

Master’s or Doctoral degrees may substitute for experience

Tools

PCR/qPCR equipment

Next-generation sequencers

Job description

Job Description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Location: Onsite - Position is based in Madison, WI. Hours: 1st shift, 8am-4:30pm.

Essential Duties

• Provide technical and product support to Operations working cross-functionally with the Production, QC, Supply Chain, R&D, and Quality teams.
• Perform investigative testing for Out of Specification events (OOS), non-conformances (NCMRs), and corrective action preventive action (CAPA) plans through root cause investigation, experiment design, study execution, data analysis, and reporting.
• Provide support for PCR-based and/or NGS-based reagents and products.
• Provide support to Operations teams for qualifying new raw materials and alternative supply channels for products.
• Demonstrated proficiency in a variety of basic laboratory skills and techniques.
• Basic knowledge base in Molecular Biology, Biochemistry, Biotechnology, Chemistry, or a related field.
• Good understanding of in-vitro diagnostic product manufacturing processes and relevant assays (e.g. biochemical, RT-PCR, and NGS).
• Program, operate, and troubleshoot complex instrumentation such as microplate readers, real-time and digital polymerase chain reaction (PCR) instruments, next-generation sequencers, and liquid handling automation.
• Assist development and characterization of simple manufacturing processes incorporating industry standard techniques.
• Assist characterization of basic assay variability for simple measurement systems.
• Apply basic statistical techniques: assessing data normality, control charting and data trending, hypothesis testing, assessing variation, linear regression and model fitting.
• Analyze data to identify trends, assists troubleshooting and root cause investigation efforts with ability to utilize recognized root cause analysis tools.
• Assist investigations into analytical and functional assays, associated equipment, materials, and/or processes.
• Clearly and accurately generate experimental protocols, draft work instruction procedures, test methods, and summarize development activities through technical summary reports.
• Support Process and Test Method Validation readiness and execution.
• Provide support and review in generating Validation documentation.
• Write new and edit existing Quality System documents (e.g. work instructions, standard operating procedures).
• Responsible for generating/driving corrective actions/action plans for changes.
• Collaborate with other departments (Quality Engineering, R&D, Regulatory Affairs, Supply Chain, Production, Validation, Quality Control) to achieve business results.
• Able to meet objectives without negatively impacting other functions.
• Actively participates in project execution.
• Consistently hit deliverables as outlined by manager.
• Function independently with limited guidance from supervisor as well as part of a team.
• Adaptable to rapid changes in priorities, strong sense of urgency, and able to identify ways to work together to achieve results needed for all requests.
• Strong verbal and written communication skills.
• 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.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work designated schedule.
• Ability to work nights and/or weekends, as needed.
• 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 work on a computer and phone simultaneously.
• Ability to use a telephone through a headset.
• 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 lift up to 40 pounds on an occasional basis.
• Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability to use various types of laboratory equipment; including microscopes, microtomes, blades, strainers, and pipettes for extended periods of time.
• May perform repetitious actions using lab tools.
• Ability to use near vision to view samples at close range.
• May be exposed to hazardous materials, tissue specimens, and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
• Ability to work with blood, tissue, stool, or other human specimen samples.
• Ability and means to frequently travel between local Exact Sciences locations.
• Ability to travel 5% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• Bachelor’s degree in life sciences or field related to the essential duties of the job.
• 2+ years of experience in the life sciences industry.
• Master’s or Doctoral degrees may be considered in lieu of 2 years of experience.
• Proficient in MS Office Suite (Word, Excel, Outlook, PowerPoint).
• 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

• Proficiency with statistical analysis software and/or programming (e.g. JMP, R).
• Experience working within an FDA 21 CFR 820, ISO 13485, and/or cGMP structured environment.
• Experience with in-vitro diagnostic product development, design transfer, manufacturing, or product support.
• Experience in a biotech or molecular diagnostics laboratory with nucleic-acid–based workflows (e.g. PCR/qPCR).
• Familiarity with CAP/CLIA regulatory requirements as they pertain to in vitro diagnostics.

Equal Employment Opportunity

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Base Pay

The base pay for this position is $50,700.00 – $101,300.00

Additional Information

• JOB FAMILY: Manufacturing
• DIVISION: ONCO Cancer Diagnostics
• LOCATION: United States > Madison : 650 Forward Dr
• ADDITIONAL LOCATIONS:
• WORK SHIFT: Standard
• TRAVEL: Not specified
• MEDICAL SURVEILLANCE: No
• SIGNIFICANT WORK ACTIVITIES: Not Applicable

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.