Manager, Product Support

Thornton Tomasetti; United States; On-site; USD 114,000 - 228,000; Full time

Benefits offered by this job

Free medical coverage in HIP PPO plan

Strong retirement savings contribution

Tuition reimbursement and FreeU ed. 혜택

Freedom 2 Save student debt program

Job summary

Abbott in La Jolla, CA, seeks a Manager, Product Support within Operations for Design Transfer of new products and post-launch support in the Cancer Diagnostics division. You will lead a Manufacturing Sciences team, oversee analytical methods, and drive risk mitigation with R&D, Manufacturing and Supply Chain.

Responsibilities include leading cross-functional projects, supervising staff, and delivering robust test methods while mentoring future leaders in a fast-paced environment.

Qualifications

• Bachelor’s degree in Chemistry, Molecular Biology or related field; or an Associate’s degree and 2 years of relevant experience in lieu of bachelor’s degree.
• 10+ years of experience with biochemical and molecular based products.
• 5+ years of direct leadership experience.
• 2+ years of experience with next-generation sequencing technology
• Professional working knowledge in Microsoft Office.
• Professional working knowledge with 21 CFR Part 820, ISO 13485, and/or cGMP structured environments.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Responsibilities

• Lead a Manufacturing Sciences team driving initiatives that align with business needs.
• Provide technical leadership and support for NGS-based reagents and products.
• Collaborate with R&D to transfer, scale, and validate manufacturing processes for Design Transfer.
• Develop, qualify, and troubleshoot analytical and manufacturing test methods and materials.
• Lead investigations and CAPA plans through root cause analysis and data interpretation.
• Mentor managers and leaders; manage multiple projects with shifting priorities.
• Communicate goals clearly and maintain team morale in a fast-paced environment.

Skills

NGS knowledge

Leadership

Project management

Statistics & experimental design

JMP software

Six Sigma / Lean

Microsoft Office

Education

Bachelor’s degree in Chemistry or Molecular Biology or related field

Associate’s degree + 2 years relevant experience (in lieu of bachelor)

Tools

Microsoft Office

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.

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life.

You’ll also have access to:

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works in La Jolla, CA supporting our Operations team in the Cancer Diagnostics division.

We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, and toxicology. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges. Our molecular division delivers best-in-class innovative testing solutions for people around the world to provide answers to life’s critical health decisions. We help people live full and healthy lives through our accessible, molecular-based solutions.

Position Overview

The Manager, Product Support role will lead a diverse team within Operations responsible for Design Transfer of new products, post-launch product support, complex issue resolution, process improvement/enhancement, and risk mitigation activities primarily within next-generation sequencing (NGS). This role will be responsible for study design, execution, reporting and will equip, staff, and establish systems and procedures in close coordination with R&D, Manufacturing, Supply Chain, and other stakeholders. The Manager, Product Support role will oversee cross-functional projects and implement best practices to ensure the area meets business needs and will lead the Manufacturing Sciences team by setting direction and creating a work environment that encourages goal realization and employee growth.

Essential Duties

• Lead a Manufacturing Sciences team driving initiatives that align with business needs.
• Provide technical leadership and support for NGS based reagents and products.
• Serve as Operations core team member for new product pipeline projects collaborating with R&D in developing, transferring, scaling, and validating manufacturing processes and quality control test methods for commercial release as part of Design Transfer.
• Oversee activities related to developing, qualifying, and troubleshooting analytical and functional test methods, manufacturing processes, and materials associated with oligonucleotides, enzymes, antibodies, and molecular biology reagents used in complex molecular diagnostics products.
• Lead and support troubleshooting of Out Of Specifications (OOS), non-conformances (NCMRs), and corrective action preventive action (CAPA) plans through root cause investigation, experiment design, study execution, data analysis, and reporting.
• Provide technical leadership and assistance in Supplier Change Requests (SCR), raw material feasibility, alternative supply evaluation, and risk mitigation activities.
• Interact with vendors on a technical level to resolve challenges with raw materials or processes established and/or develop new processes to implement with our strategic partners to improve reliability of incoming materials.
• Generate clear and accurate experimental protocols, draft procedures, characterize and develop test methods and test method improvements summarizing activities through technical or investigative reports.
• Provide needed visibility and supporting information to assist leadership in prioritization of projects based on changing functional needs, resource capacity constraints, risk exposure, and ensuring clarity in project interdependencies.
• Oversee design and execution of complex studies and designed experiments using appropriate statistical techniques.
• Oversee design and execution of stability studies according to recognized standards.
• Provide thought leadership in design for manufacturability for future products and test methods in collaboration with R&D.
• Oversee teams conducting bench level experiments within several product or technology areas to identify problems and discrepancies.
• Mentor next level managers and leaders within the functional work-streams to continue to grow talent within our organization.
• Lead and manage several varied projects at one time, with frequent changing priorities.
• Supervise staff including but not limited to organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance.
• Communicate goals clearly to employees to ensure understanding and success in achieving them.
• Motivate and inspire employees to do their best work through coaching.
• Maintain morale and support employee engagement initiatives.
• Communicate to all levels within the company and thrives in a fast-paced, everchanging environment.

Minimum Qualifications

• Bachelor's degree in Chemistry, Molecular Biology or a field related to the essential duties of this role; or an Associate's degree and 2 years of relevant experience in Chemistry, Molecular Biology or field related to the essential duties of this role in lieu of bachelor’s degree.
• 10+ years of experience with biochemical and molecular based products.
• 5+ years of direct leadership experience.
• 2+ years of experience with next-generation sequencing technology
• Professional working knowledge in Microsoft Office.
• Professional working knowledge with 21 CFR Part 820, ISO 13485, and/or cGMP structured environments.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

• 10+ years of experience with Medical Device Products in a Product Development, Product Support, or Quality Control role.
• 7+ years of experience with Project Management principles and practice.
• 3+ years of experience leading or directing people and/or project teams utilizing NGS.
• Professional working knowledge in statistical and mathematical methods in biology/genetics, including experience with JMP software.
• Professional working knowledge in Design for Six Sigma and Statistics.
• Professional working knowledge in basic and advanced continuous improvement methodologies/ principles such as LEAN Six Sigma and/or Practical Process Improvements (PPI).

The base pay for this position is $114,000.00 – $228,000.00

JOB FAMILY: Manufacturing DIVISION: ONCO Cancer Diagnostics LOCATION: United States > La Jolla : Torrey Pines Science Park

ADDITIONAL LOCATIONS: United States > Madison : 1 Exact Lane

WORK SHIFT: Standard

TRAVEL: No

SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

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.

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Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.