Success Profile

Courageous
Results-driven
Proactive
Problem-Solver
Leadership
Team player

Job Summary

This role includes duties related to analytical work required to support the development and launch of new products in the Chattanooga Development Center. This work includes raw material evaluation, prototype testing and development, method execution, creation, and validation, as well stability design and execution. It also addresses all aspects of the fundamental chemistry of new products and creates the required training for lower-level ARD and IA testing positions. The position will prepare reports, track projects, perform hands-on lab work, represent the analytical perspective on interdepartmental teams, and evaluate literature related to methods, regulations, and GMP activities.

Knowledge And Skills:

• Extensive specific experience in the analytical methods and processes for CHC development.

• Core laboratory techniques and fundamental data analysis.

• Good Manufacturing Practice

• ICH, FDA Guidance

• Sanofi Standard Operating Procedures

• Knowledge of the analytical portion of drug registrations.

• Interpreting and executing FDA, Pharmacopeial, and literature methods.

• Stability Study Procedures

• Technology transfers.

Formal Education and Experience Required:

• Minimum of a bachelor’s degree in chemistry or related field required. (Ph.D. preferred unless extensive specific experience exists to support BS degree)

• Demonstrated self-motivation

• Demonstrated problem solving ability

• Extensive GMP experience.

• Experience writing methods and analytical reports.

• Extensive Experience answering audit questions.

• Experience with the analytical portion of drug registrations.

• Experience with planning projects.

• Experience with organizing teams and workflows.

• Experience interpreting and executing FDA, Pharmacopeial, and literature methods.

• Experience interpreting stability study trends.

• Experience with technology transfers from other development sites.

• Experience with core analytical techniques including but not limited to HPLC, GC, IC, ICP, and spectroscopy

MAJOR DUTIES & RESPONSIBILITIES:

• Develop and validate methods independently,

• Perform wet chemistry testing.

• Drive acquisition of new analytical techniques

• Conduct novel analytical experimentation to drive new product development.

• Create and execute training materials for other analytical DC team members.

• Prepare analytical experiments and reports to support FDA registrations

• Help develop new simplified and efficient analytical processes

• Evaluate new raw materials

• Develop and validate methods for new CHC products

• Design and perform stability tests for new CHC products.

• Lead problem solving for development challenges

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.