Scientist, Formulation Development
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The Analytical and Formulation Development group supports the development, manufacture, and improvement of Flublok influenza vaccine and the development of related vaccine candidates, including a pandemic influenza vaccine, Panblok. Development work includes the characterization of protein targets due to seasonal changes in the circulating strains, process improvements, and/or process changes. The group is also responsible for the development reagents, new assays and for identifying formulation conditions for both new vaccine candidates and for existing vaccines to improve stability and increase shelf-life. The group supports vaccine manufacture through batch monitoring studies and leads investigations into process and product related issues.
Candidate will contribute directly to the development of stable, single dose and multi dose formulations of Panblok with MF59 adjuvant. This work is sponsored by BARDA and has clearly defined deliverables and milestones. To develop a Panblok/MF59 vaccine, the candidate will be required to develop and optimize formulations, as well as, the analytical assays to characterize those formulations. In addition, the scientist will play an active and integral role in the development of assays including potency assay for the characterization and release of COVID-19 vaccine. 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.
- Develop stable single dose and multi dose formulation of Panblok with MF59, and develop assays to monitor and characterize the protein and formulations using biophysical and biochemical methods and techniques such as Sodium Dodecyl Sulfate-Polyacrylamide Electrophoresis (SDS-PAGE), Dynamic Light Scattering (DLS), Single Radial Immunodiffusion (SRID), , Differential Scanning Fluorimetry (DSF), Bi-layer Interferometry (Octet), Infrared spectroscopy (IR), , and Circular Dichroism Spectroscopy.
- Transfer formulation to a CMO for the fill finish of the vaccine for the clinical trial.
- Design and execute studies to evaluate the hold time and final container stability of Panblok/MF59 formulations.
- 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, 2-5 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, and SRID is a plus.
- 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.
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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