Manager Scientist, Formulation Development
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The Analytical and Formulation Development group supports the development, manufacture, and improvement of Flublok influenza vaccine, development of COVID19 vaccine and the development of other 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.In addition, the team is responsible for the development of new and improved 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 deviations.The team is also responsible for the batch monitoring of the COVID 19 DS batches produced at various CMOs to demonstrate the process consistency and the robustness of the process.
Candidate will contribute directly to the batch monitoring program for the COVID 19 Vaccine produced across sites and by different CMOs. The incumbent will be responsible for collecting and analyzing data to demonstrate the consistency and robustness of the process. This work is sponsored by BARDA and has clearly defined deliverables and milestones. The scientist will use existing biophysical and biochemical assays and will also play an active and integral role in the development of new characterization assays such as FTIR, CD spectroscopy and flow imaging microscopy. The incumbent will design and execute required experiments and studies with the support of the manager, and the hands-on assistance of a laboratory associate. The successful candidate will be able to trouble shoot and investigate protein stability and analytical testing issues, analyze and trend stability data, and transfer the procedures and methods to contract manufacturing organization and other testing laboratories. Data will be documented in laboratory notebooks, procedures and plans will be documented in SOPs and study protocols, and results and findings will be documented in development and study reports. Candidate will accomplish these tasks in a laboratory setting and through collaborations both internal and external.
Perform batch monitoring of the DS batches produced at different sites across Sanofi network and also by CMO using biophysical and biochemical methods and techniques such as Sodium Dodecyl Sulfate-Polyacrylamide Electrophoresis (SDS-PAGE), Dynamic Light Scattering (DLS), Differential Scanning Fluorimetry (DSF), Bi-layer Interferometry (Octet), Infrared spectroscopy (IR), Flow imaging microscopy, and Circular Dichroism Spectroscopy.
Identify stability and formulation issues and evaluate potential solutions and improvements independently.
Function as a lead and subject matter expert in investigations to support vaccine development and manufacturing.
Participate in cross-functional teams to manage the project and transfer the technology.
Manage and train laboratory associate on procedures and studies.
Adhere to company policies and maintain documentation and records of laboratory data and results.
Provide and write status updates, assessments, study protocols, development reports, and written procedures (SOPs), and publish manuscripts in peer reviewed journals where appropriate.
Maintain a knowledge of the scientific literature.
Present ideas, concepts, and findings internally and externally and represent the company at national and international scientific conferences.
MS or Ph.D. degree in Biochemistry or relevant field including Biophysical Chemistry, Biology, Pharmacy, Biomedical Engineering or combination of experience and training that is equivalent.
5-8 years of experience with MS, 1-2 years of experience with Ph.D.
2-5+ years of hands on experience in the characterization of vaccines and biologics in a pharmaceutical or biotechnology industry setting preferred.
Experience in biophysical and biochemical characterization of proteins and a familiarity with state of the art biophysical and biochemical assays such as DSC, DLS, DSF, Bi-layer Interferometry, CD Spectroscopy, FITR etc.
Experience in developing novel formulations
Familiarity with cGMPs and/or vaccine manufacturing is a plus.
Experience in managing multiple projects and laboratory personnel.
Excellent verbal and written communication skills.
Having experience in managing associates is a plus.
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.
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