Quality Control Microbiology (QCM) is responsible for testing intermediate production samples, final product samples, and environmental samples to demonstrate that all products meet the standard requirements for CGMP operations. Additional functions include raw material testing, stability testing, assay transfers, and qualification of instrumentation. The Quality Control Operations group supports Laboratory Investigations, Deviation Investigations, CAPA support, Training, and Change Controls.
The Quality Control Microbiology (QCM) Science and Tech team works to develop, validate, transfer, and support life cycle of microbiological methods; trouble-shoot methods for Quality Control Laboratories globally; and to support regulatory submissions and post-approval commitments.
Perform laboratory assays in support of method development, qualification, validation, method transfer, product release, stability, and process validation and investigations.
Perform maintenance on complex laboratory equipment.
Review data for compliance to procedures and specifications.
Participate in training of less experienced staff.
Write and revise SOPs; assist in writing protocols and technical reports for methods and QCM equipment.
Develop and author complex, explicit documentation for new and current procedures, validation protocols and technical reports.
Design and execute microbiological method development, qualification, and validation.
Interface with external regulatory agencies as required.
Solve assay/analytically-related process problems.
Determine technical objectives and approaches to assignment.
Guide the successful completion of major projects and may function in a project leadership role.
Independently employ in-depth technical knowledge to define and manage laboratory studies on investigations of quality control procedures.
Understand and interpret results and how they impact the design of subsequent experiments.
Participate in project strategy in consultation with supervisor and/or colleagues.
Represent the organization in providing solutions to difficult technical issues associated with specific projects.
Adhere to Sanofi GMP and safety procedures and guidelines.
Bachelor's degree in a scientific discipline and 4 years experience in GMP pharmaceutical/biotech or other relevant industry, or equivalent (equivalent may be 8+ years in scientific discipline).
or Master's Degree in a scientific discipline and 2+ years of relevant experience in a GMP environment, or equivalent.
Experience in Method Development, Validation and Transfer.
Ability to manage projects.
Advanced degree (Master's or PhD) and relevant experience.
Experience in leading groups and projects.
Technical expertise in several analytical platforms.
Strong and effective written and verbal communication skills.
Effective presentation skills.
Knowledge of USP and global compendial regulations for analytical methods.
SPECIAL WORKING CONDITIONS
Ability to perform laboratory work using chemicals as required
Ability to occasionally lift up to 25 lbs.
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.
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.