ANALYTICAL METHODS DESIGN SPECIALIST

Description

Position Summary: Develop and implement analytical methodologies for quality control of products and raw materials used in research and development at Abbott. Key Highlights: 1. Opportunity for impact and professional growth within a global industry leader. 2. Company recognized for its inclusive and diverse workplace culture. 3. Develop and standardize analytical methodologies for new products. **Analytical Methods Design Specialist**### **At Abbott, we promote equal opportunity. We invite applications from all individuals with disabilities, ensuring an inclusive and accessible selection process. A valid disability certificate issued by an authorized entity is required to guarantee appropriate support and accommodations throughout the process.** ### **About Abbott** ### **Abbott is a global healthcare leader, creating innovative science to improve people's health. We constantly look ahead, anticipating advances in medical science and technology.** ### **Working at Abbott** ### **At Abbott, you can do work that matters, grow and learn, take care of yourself and your family, be authentically you, and live a fulfilling life. You will have access to:** * ### **Professional development with an international company where you can build the career you dream of.** * ### **A company recognized as a top workplace in dozens of countries worldwide and named one of the world’s most admired companies by Fortune magazine.** * ### **A company recognized as one of the best large employers for working mothers, executive women, and scientists—and one that values diversity.** ### **The Opportunity** ### **This position is located in Cali within the Established Pharmaceuticals Division. We are committed to delivering the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality, branded generic medicines spans multiple therapeutic areas, including gastroenterology, women’s health, cardiometabolic health, pain management / central nervous system, and respiratory care. As an Analytical Methods Design Specialist, you will develop and implement analytical methodologies for quality control of products and raw materials used in research and development.** ### **What You’ll Do:** * ### **Standardize analytical methodologies for new products and reformulations based on current official pharmacopoeias and/or available scientific literature.** * ### **Support formulation and new product development activities in research and development, including comparative dissolution profiling, physicochemical analysis of raw materials, reformulation testing, and pilot batches of new and reformulated products.** * ### **Develop analytical procedures for new products, reformulations, and raw materials.** * ### **Perform physicochemical analysis of raw materials and research-and-development products.** * ### **Deliver analytical reports documenting activities conducted during the development of new methodologies for raw materials and products.** * ### **Participate in tracking and closing action plans defined as a result of nonconformance and/or corrective and preventive action analyses.** * ### **Review analytical procedures for finished products generated during analytical methodology implementation.** * ### **Review protocols and reports for validation of analytical methods used in research and development.** * ### **Conduct periodic reviews of validations for all products and raw materials.** * ### **Review and assess the impact of change controls.** * ### **Review proposed change controls for analytical methods affecting validations or requiring revalidation.** * ### **Review and verify obvious errors and determine corrective actions.** * ### **Assign sequential numbers to identified obvious errors.** * ### **Maintain an inventory of sequential numbers assigned to open LIRs in the SolTRAQs system.** * ### **Jointly review out-of-specification, out-of-trend, or aberrant results with the responsible analyst to determine whether a Phase I laboratory investigation is necessary or if the result constitutes an obvious error.** * ### **Conduct laboratory investigations.** * ### **Prepare reports on metrics for obvious errors and Phase I and II laboratory investigations.** * ### **Track corrective and preventive actions outlined in the metrics report for obvious errors and Phase I and II laboratory investigations.** * ### **Provide information related to performance indicators for the analytical design and validation processes in research and development; evaluate goal attainment; and propose strategies to improve outcomes.** * ### **Participate in tracking and closing action plans defined as a result of nonconformance and/or corrective and preventive action analyses.** * ### **Support responses to regulatory agency requests.** ### **Required Qualifications** ### **Education: Chemist or Pharmaceutical Chemist** ### **Minimum 4 years’ experience in analytical method validation (API, finished product, and trace analysis) and analytical method design** ### **Apply Now** ### **Pursue your professional aspirations with Abbott to explore diverse opportunities at a company that helps you build your future and live your best life. Abbott is an equal opportunity employer committed to workforce diversity.** ### **Connect with us at** **www.abbott.com****, on Facebook at** **www.facebook.com/Abbott** **and on Twitter @AbbottNews and @AbbottGlobal