Analytical Chemist II

Job Summary

Aiming to prioritize and expedite execution of strategic projects related to product life cycle and COGS optimization, this position encompasses all of the Analytical Chemist I duties along with the additional duties of creating methods or procedures for the support of lifecycle management and technical compliance that are used by the laboratory positions.  This position will report directly to KSOL and will have dotted line with the QA Associate Director. Under the guidance of QA, the position generates the documentation for methods, stability studies, and cleaning studies required to support life cycle management and regulatory compliance.  This position also performs and designs the testing required for evaluation, maintenance, and approval of raw materials used in currently marketed Sanofi CHC products.

Location

Position is based in Chattanooga, TN. This position may require the ability to travel.

Role Specific Responsibilities

Analytical Chemist II’s duties fall under the scope of the execution and maintenance of methods and techniques in support of lifecycle management and general problem solving to support quality assurance, quality control, and operations. This process includes the support of methods and protocols for process validation, packaging validation, and cleaning validation programs as well as the execution and writing of reports for validation projects.  Critical to this scope of responsibilities is the ability to create in writing the theoretical, mathematical, and practical aspects of all methods using the literature as a starting point.  This position will potentially lead teams within AQA and across departments.  While receiving general guidance from KSOL and the Associate Director, QA, this position will handle the majority of its responsibilities with minimal supervision and review.

It is essential that a person in this position demonstrates the potential skills and problem solving ability to progress to the Analytical Chemist III position. After 8 years in this position, a Chemist may progress to the Analytical Chemist III position.

• Execution of methods and techniques for the raw material evaluation program

• Execution of methods and techniques for the process validation program

• Maintenance and possibly development of methods and techniques for the accelerated stability program

• Execution of methods and techniques for the cleaning validation program

• Development and execution of methods for technical compliance of currently marketed products

• Provides support for projects related to transfer of products to a CMO or to the site

• Management of method validation projects

• Management of raw material evaluation projects

• Preparation of Validation reports

• Tracking progress of all projects

• Transfer and Validation of compendial methods

• Written development of the theory, mathematics, and practical execution of compendial and in-house methods

• Written preparation of reports, change requests, GMP documentation with strong attention to detail

• Design of testing of materials for approval for use in Sanofi CHC products

• Detailed working knowledge of instrumentation and maintenance

• Support of laboratory personnel such as Analytical Chemist I and III

• Participation on laboratory teams to purchase instruments

• Troubleshoot and solve problems within AQA and across departments

• Interaction with vendors to compile necessary documentation and supplies

• Training of AQA, ARD, QC, and Operations personnel

Interfaces

• Quality Control

• Procurement

• Process Engineering and Validation

• Analytical Research and Development

• CHC Research and Development

• Operations

Competencies

• Analytical experience

• Problem solving

• Technical writing

• Oral communication

This description is representative, but not inclusive of all position responsibilities. Associate may be asked from time to time to complete tasks not listed within the contents of this document, but that are relative to the goals of the business.

Qualifications

Education:  A minimum Bachelor’s degree from an accredited college in Chemistry, Pharmaceutical Sciences, or closely related field required.

Experience:  A minimum of 4-5 years of analytical experience is preferred.

Laboratory Skills:  HPLC, GC, IC, ICP, AA, and UV preferred. Wet chemistry experience required.

Role Specific Competencies

• This position requires extensive use of computer equipment.

• Must have a demonstrated proficiency in Microsoft business software to include Excel, Word, and Outlook.

• Strong verbal and written communication skills are required.

• Experience with Chemstation and Openlab software is desired.

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.