Principal Scientist in Technical Support
1 week ago
The Opportunity
This role operates within the Molecular Group at Abbott, a frontrunner in the field of molecular diagnostics, focusing on the intricate analysis of DNA, RNA, and proteins.
The Principal Scientist will play a pivotal role in the support of the on-market assay reagent team within Abbott's Technical Support division, specifically for the FISH/Oncology, m2000, and Alinity platforms. Responsibilities include leading design modifications for existing products, managing supply chain challenges, spearheading CAPA investigations, and overseeing routine product registrations and renewals. Additionally, this role will take charge of special projects and support both the CAPA and Material Review Boards.
Collaboration is key; the Principal Scientist will work closely with Operations, Quality, and Regulatory teams while also liaising with Marketing and Scientific Affairs. Staying informed about new product developments and proactively assessing their impact on the support organization is essential.
Key Responsibilities
- Technical Expertise: Utilize comprehensive knowledge of operations, products, and processes related to Molecular Diagnostics reagents. Employ sound judgment and scientific methodologies to conduct thorough data analysis.
- Problem Solving: Anticipate, identify, and resolve technical challenges effectively.
- Project Leadership: Conceptualize, design, and lead projects aligned with strategic business objectives. Serve as a subject matter expert on product families and demonstrate the ability to tackle complex system-level issues. Research and suggest innovative methods, technologies, or process applications.
- Scientific Communication: Clearly communicate the implications of scientific observations to relevant divisions.
- Quality Assurance: Ensure compliance with the Quality System and maintain its effectiveness.
- Design Control: Author, execute, and review complex system-related verification and characterization protocols, including acceptance criteria and data packages.
- Data Analysis: Apply advanced quantitative methods, analyze results, draw conclusions, and implement improvements.
- Risk Assessment: Evaluate technical, project, and product risks.
- Cross-Functional Collaboration: Present and interpret information among senior team members, scientists, engineers, and other personnel across various sites.
- Technical Representation: Convey complex technical findings in accessible formats. Collaborate effectively with cross-functional teams and external partners.
- Leadership and Mentorship: Develop and review project timelines and resource estimates, providing guidance to other technical personnel.
- Process Development: Contribute to the creation of departmental and site processes and procedures.
- Communication Skills: Facilitate problem resolution across teams to minimize recurrence.
- Investigation Management: Independently oversee complex investigations, employing advanced statistical techniques and project management tools.
Required Qualifications
- Bachelor's Degree in Chemistry, Biology, or a related scientific discipline, or an equivalent combination of education and experience.
- A minimum of 8 years of relevant professional experience.
- Comprehensive understanding of the specified functional area.
- Proficiency in theoretical and practical fundamentals of chromatography, polymer chemistry, and spectroscopy.
- Extensive analytical, design, and problem-solving skills related to the development, qualification, validation, and transfer of diverse analytical methods for characterization and testing of APIs, raw materials, and drug products in a regulated environment.
- Significant experience working under GMP and GLP conditions, with a solid understanding of cGMP, ICH, USP, and FDA guidelines.
- Familiarity with Alinity platforms or PCR assays.
- Experience with DOMO, SAP, and statistical software such as JMP.
- Proven experience in supporting on-market products.
- Background in the development of PCR assays.
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