ANALYTICAL METHODS DESIGN SPECIALIST

Description

Job Summary: Analytical Methods Design Specialist responsible for developing and implementing analytical methodologies for quality control of R&D products and raw materials. Key Highlights: 1. Professional development at a leading international healthcare company 2. A company recognized as the best place to work and admired globally 3. Opportunity to impact global health in established pharmaceuticals ### **Analytical Methods Design Specialist** ### **At Abbott, we promote equal opportunity. We invite all individuals with disabilities to apply, 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 leader in healthcare, creating innovative science to improve people's health. We are always looking ahead, anticipating changes in medical science and technology.** ### **Working at Abbott** ### **At Abbott, you can do meaningful work that makes an impact, grow and learn, care for 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 achieve the career you dream of.** * ### **A company recognized as the best place to work 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, female executives, and scientists—and one that values diversity.** ### **The Opportunity** ### **This position is located in Cali within the Established Pharmaceuticals division. We are committed to bringing the benefits of our reliable 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, pain management / central nervous system, and respiratory. As an Analytical Methods Design Specialist, you will develop and implement analytical methodologies for quality control of R&D products and raw materials.** ### **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 R&D, including comparative dissolution profiling, physicochemical analysis of raw materials, reformulation testing, and pilot batches of new products and reformulations.** * ### **Develop analytical procedures for new products, reformulations, and raw materials.** * ### **Perform physicochemical analysis of raw materials and R&D products.** * ### **Deliver analytical reports documenting activities conducted during the development of new methodologies for raw materials and products.** * ### **Participate in tracking and completing action plans defined as a result of non-conformance and/or corrective and preventive actions (CAPA) analysis.** * ### **Review analytical procedures for finished products generated during analytical methodology implementation.** * ### **Review protocols and validation reports for R&D analytical methods.** * ### **Conduct periodic review 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 necessary corrective actions.** * ### **Assign sequential numbers to identified obvious errors.** * ### **Maintain inventory of sequential numbers for open LIRs in the SolTRAQs system.** * ### **Jointly review out-of-specification (OOS), out-of-trend (OOT), or aberrant results with the responsible analyst to determine whether a Phase I laboratory investigation is required—or if the result constitutes an obvious error.** * ### **Conduct laboratory investigations.** * ### **Prepare metrics reports on obvious errors and Phase I and II laboratory investigations.** * ### **Track corrective and preventive actions outlined in the metrics report on obvious errors and Phase I and II laboratory investigations.** * ### **Provide information related to performance indicators for the analytical design and R&D validation processes; evaluate goal attainment; and propose strategies to improve outcomes.** * ### **Participate in tracking and completing action plans defined as a result of non-conformance and/or corrective and preventive actions (CAPA) analysis.** * ### **Support responses to regulatory authority requests.** ### **Required Qualifications** ### **Education: Chemist or Pharmaceutical Chemist** ### **Experience: 3 to 5 years of experience in analytical method validation (API, finished product, and trace analysis) and analytical method design** ### **Apply Now** ### **Pursue your professional aspirations with Abbott to access diverse opportunities with a company that can help 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.