Manager Scientist - Vaccine | Alabaster, AL

to deliver robust and efficient processes & testing with associated knowledge to transfer to Manufacturing & QC. The MSAT function also provides daily support to manufacturing and QC toward industrial performance excellence. The individual in this position will: Drive the technical strategy and project deliverables across the Injectables (Drug Product) landscape for multiple projects across the Swiftwater site Serve as a technical expert for general Injectables, transfers and change management Implementation with emphasis on Formulation Comply with c GMP and other internal and external quality and regulatory guidance, as well as health and safety guidelines ACCOUNTABILITIES: Support and deliver

technical studies and validation strategies for Manufacturing assist, Tech Transfers and New Vaccines in Formulation operations Provide Shop Floor assistance to support investigations, troubleshooting, CAPA and Change Control activities Author I review I approve technical documents which support project execution and manufacturing assistance Participate, support, defend and provide technical expertise during Pre-Approval Inspections and agency inspections when required to defend studies The Job Responsibilities Include: Having a strong working knowledge of the relationship between Formulation parameters, vaccine product characteristics and critical quality attributes.

Working with different

disciplines (Quality, Operations, Regulatory, and Engineering) in the execution of development and validation studies to industrialize processes for Phase 3 and licensed products to assure commercialization of robust, compliant, and efficient processes for vaccines and bio-medicals Participating in programs that use structured methodologies such as Quality by Design, Design Space and Process Control Strategies in the course of industrial process design, validation and control.

Providing technical coaching, training and guidance to junior engineers on Formulation related subject matter Leading tactical responses to process deviations, delivering technical solutions and communicating outcomes to site management Promote innovation to keep up-to-date with the latest regulatory expectations and industry trends.

Basic Skills Bachelor's or Masters in basic sciences, math, engineering, or shop. Candidate should possess educational and professional experience, commensurate with the position. Preferred Qualifications Strong technical writing skills Ability to be flexible with schedule some off shifts Attitude of collaboration Ability to coach junior staff members Qualipso, SAP, Phenix, Trackwise proficiency Education Bachelors or Masters in basic sciences, math, engineering, or shop with 2+ years' experience or Ph D with experience in biological processes or analytics in a c GMP environment.

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; interaction, gender, gender identity or expression; affectional or interactionual 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.

#GD-SP #LI-SPAt 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.