**Monday-Friday- 8am-5pm- flexibility with start/end time
**This position is considered essential personnel - you will start onsite from Day 1**
**Experience with analytical testing**
**Working with Upstream and Downstream**
**Interaction with quality departments**
The Analytical and Formulation Development group supports the development, manufacture, and improvement of Flublok influenza vaccine and the development of related vaccine candidates, including pandemic influenza vaccines. Development work includes the characterization of target proteins due to annual strain changes, process improvements, and or process changes. The group is also responsible for the development of new assays and for identifying formulation conditions to improve stability and increase shelf-life. The group supports vaccine manufacture through batch monitoring and leads investigations into process related issues.
The candidate will be responsible for the routine characterization of process intermediates and active pharmaceutical ingredients using a wide variety of biophysical and biochemical methods. This work supports a number of programs including annual strain change, yield improvement, formulation development, comparability studies, and deviation investigations. Candidate will be required to follow standard operating procedures, execute development and stability studies according to protocols, and perform small scale drug product fills by hand. The incumbent will also perform data entry to maintain the databases. The incumbent will be expected to participate on cross-functional teams and will report to the Manager, Senior Scientist.
· Perform comparability studies for the implementation of new approaches for the yield improvement, development of chemically defined media, and second generation Fed-Batch process using the simplified feed and multiple feeding strategy,
· Perform stability studies on drug substance produced for yield or process improvement purposes.
· Support formulation and fill operations and stability studies by performing small scale vial fills by hand as necessary.
· Independently execute testing and experiments according to written procedures and protocols respectively.
· Maintain laboratory systems for tracking and monitoring both cGMP manufacturing and development by entering data and results into databases on a regular basis.
· Work independently on assigned projects with minimum supervision.
· Provide technical and hands-on support to project leads and direct report.
· Maintain laboratory notebook and adhere to procedures for additional laboratory documentation systems.
· Review and prepare written documents.
· Communicate and report results both internally and external.
· Candidate should demonstrate scientific curiosity and actively engage in problem solving activities.
· BS degree with 3-5 years of experience, or MS degree with 1-3 years of experience in the Pharmaceutical or Biotechnology industry.
· Experience in biophysical and biochemical analytical techniques such as HPLC, SDS-PAGE, DLS, and CD. Experience in the SRID assay is a plus.
· Candidate should be flexible, results oriented, and work well in a team environment.
· Candidate must be fluent in oral and written English and proficient using Excel and Word.
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.