ABOUT ABBOTT

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, nutritional and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

EDUCATION & COMPETENCIES

• A Bachelor of Science degree or higher in a relevant Chemistry, Physics or Life Science discipline. Knowledge of good laboratory practices, cGMP practices, USP methodology, FDA, ICH, OSHA, and DEA regulations, and MSDSs
• Experience and knowledge of analytical chemistry is a distinct advantage i.e. HPLC and UV-Vis, GC, FTIR and Dissolution apparatus.
• Experience and knowledge of Analytical validation and method transfers is is a distinct advantage.
• Self-motivated and significant project experience with an ability to influence others are essential.
• Excellent communication / interpersonal skills.
• A minimum of 2 years experience in medical device industry is required.

• Plan, implement and lead complex Technical projects including validation activities and product/process improvements supporting Sensor Projects. Responsible for writing up/reviewing the results and conclusions accurately and on time.
• Support the development and roll out of technical trials / characterization studies.
• Contribute to analytical development through design and execution of experiments, data analysis and communication of conclusions through presentations and reports.
• Coordinate and contribute to the design of SOPs, test methods, protocols, specifications and validation documentation (IQ/OQ/PQ).
• Plan, implement & lead analytical method transfers, optimization, and validation
• Executes experiments; participates in experimental design and utilizes DOE where appropriate.
• Participates in the planning and execution of raw material, components, and vendor qualification or alternate supplier analytical qualification studies.
• Provides analytical testing support for manufacturing process validation.
• Seek opportunities for significant, process or product improvements; considering CQAs, critical process parameters, and product performance characteristics.
• Develop and maintain project timelines and provide updates and feedback to leadership.
• Ensures prompt attention of the Technical Lead areas of risk, which might have an adverse effect on product and/or safety.
• Data management, trending and reporting of product performance and other business measures.
• Ability to interpret data, discuss findings and resolve complex analytical problems.
• Recognize adverse trends and emerging issues. Propose and implement solutions to internal and external issues.