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Lead Technical Support Scientist
2 months ago
The Opportunity
This role operates within the Technical Support division of Abbott, focusing on molecular diagnostics and the intricate analysis of biological materials.
The Principal Scientist will be instrumental in supporting the existing assay reagent team, addressing challenges related to product design modifications, overseeing manufacturing and supply chain issues, and conducting thorough investigations into corrective actions. This position will also facilitate routine product registrations and manage special initiatives, while actively participating in both the CAPA and Material Review Boards.
Collaboration is key in this role, as the Principal Scientist will engage with various departments including Operations, Quality, and Regulatory, while also liaising with Marketing and Scientific Affairs. Staying informed about new product developments is essential to effectively manage their implications on ongoing support operations.
Key Responsibilities
Technical Expertise: Utilize in-depth knowledge of operations, products, and processes related to Molecular Diagnostics reagents. Employ sound judgment and rigorous scientific methodologies alongside comprehensive data analysis. Problem Solving: Proactively identify, understand, and resolve technical challenges. Project Leadership: Conceptualize, design, and lead projects aligned with strategic business objectives. Serve as a subject matter expert on product lines and demonstrate the ability to address complex system-level issues. Research and propose innovative methods and technological applications. Scientific Communication: Effectively communicate significant scientific findings to relevant stakeholders within the organization. Quality Assurance: Ensure compliance with the Quality System and maintain its effectiveness. Design Control: Develop, execute, and review complex verification and characterization protocols, including acceptance criteria and data documentation. Data Analysis: Apply advanced quantitative techniques to analyze data, assess outcomes, draw conclusions, and implement enhancements. Risk Assessment: Evaluate potential technical, project, and product risks. Cross-Functional Collaboration: Present and interpret technical information to senior team members, scientists, engineers, and other personnel across various sites. Mentorship: Provide guidance and support to other technical staff, creating and reviewing project timelines and resource estimates. Communication and Leadership: Share problem resolution strategies across teams to prevent recurrence. Investigation Management: Independently oversee complex investigations, employing advanced statistical methods and project management tools. Technical Leadership: Offer insights into departmental processes and procedures, ensuring alignment with organizational goals.Required Qualifications
Bachelor's Degree in Chemistry, Biology, or a related scientific discipline, or equivalent experience. A minimum of 8 years of relevant professional experience. Comprehensive understanding of the functional area. Proficiency in chromatography, polymer chemistry, and spectroscopy. Extensive analytical and problem-solving skills in the context of method development, qualification, validation, and transfer of analytical techniques. Familiarity with regulatory standards such as GMP, GLP, ICH, USP, and FDA guidelines. Experience with Alinity platforms or PCR assays. Proficient in using software tools like DOMO, SAP, and statistical analysis software. Background in supporting existing products and developing PCR assays.