Principal Technical Support Scientist

1 month ago

Des Plaines, United States Abbott Full time

The Opportunity

This position works on site out of our Des Plaines, IL location in the Molecular Group. Abbott Molecular is a leader in molecular diagnostics and the analysis of DNA, RNA, and proteins at the molecular level.

This role will support the on-market assay reagent team within Abbott Molecular’s Technical Support organization for the FISH/Oncology, m2000, and Alinity platforms. The Principal Scientist will lead on-market design changes, help manage manufacturing and supply chain disruptions, lead CAPA investigations, support routine product registrations and renewals, and lead special projects. The Principal Scientist will also support both the CAPA & Material Review Boards.

The Principal Scientist Technical Support will work in collaboration with Operations, Quality, and Regulatory functions and liaison with Marketing and Scientific Affairs. The role will keep up to date with the development of new products and pro-actively manage the impact of new products on the on-market support organization.

What You’ll Work On

Technical Knowledge: Develop and apply operations/ product/ process knowledge to Molecular Diagnostics reagents. Use sound judgment and appropriate scientific methods and thorough data analysis. Anticipates, recognizes, and resolves technical problems. Conceptualizes, designs, and leads projects driven by strategic business needs. Subject matter expert on product families and exhibits ability to identify and resolve complex system-level problems. Researches and proposes new methods, technology, or process applications. Identifies/communicates to other areas in the division implications of relevant scientific observations. Maintains adherence to Quality System - Implements and maintains the effectiveness of the quality system Design Control - Writes, executes and provides technical review of complex system related verification and or characterization protocols including acceptance criteria and data packages Applies complex quantitative methods, analyzes data, evaluates results, forms conclusions and provides and implements improvements Risk Mitigation - Evaluates technical, project, and product risks Collaborates across functional areas - Presents, delivers and interprets information amongst senior team members, scientists, engineers, Quality, Regulatory, and other personnel across sites. Can represent complex technical findings in succinct non-technical formats. Works well with CFT members, Support Organizations and external Partners in a collaborative, goal-driven environment. Technical Leadership and Mentoring - Creates and reviews project and design timelines and task sets, recommends resource estimates for project plans, timelines and impact of project scope changes. Provides input into developing departmental and site processes and procedures. Provides technical leadership and mentoring. Communication/Leadership: Communicates problem resolution across teams to minimize potential reoccurrences. Demonstrates fiscal responsibility through actionable recommendations and accomplishments such as maintaining product availability and improvements in product sustainability. Internal CAPA Investigations - Independently manages complex investigations to resolution. Demonstrates advanced statistical techniques, DMAIC and or project management tools. Provides audit inputs and support as required. Receives infrequent direction and provides work directions for other technical personnel.

Required Qualifications

Bachelor's Degree in Chemistry, Biology or related scientific field or an equivalent combination of education and work experience.

Minimum 8 years relevant work experience

Requires complete understanding of specified functional area.

Experience in the theoretical and practical fundamentals and experimental research techniques in chromatography, polymer chemistry and spectroscopy.

Extensive analytical, design and problem solving skills specific to development, qualification, validation and transfer of diverse analytical methods for characterization & release/stability testing of APIs, raw materials, and drug products in a regulated environment. Extensive working experience under GMP and GLP conditions, with firm knowledge of cGMP, ICH, USP and FDA guidelines.

Experience with any Alinity platform or PCR assays

Experience with DOMO, SAP, and use of statistical software such as JMP

Experience supporting on-market products

Experience in the development of PCR assays

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