Essential Funcitons:
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- Initiate and manage vaccine Stability Program activities. Including authoring of internal Stability Protocols. Reviewing all stability data – conducting basic trending and statistical analysis for extrapolation.
- Support development activities such as stability studies for thermal, freeze/thaw, photostability, and new container closure system evaluation for both Drug Substance (DS) and Drug Product (DP) materials.
- Support in product investigations, working with cross functional teams for investigations related quality issues, deviations, out-of-specification results, and anomalies at all stages of vaccine development, from early development to late-stage phases.
- Support coordination of sample distribution and management of data results. Organize and train new personnel on new and emerging stability processes, provide guidance on these techniques to other technical staff.
- Contribute to the creation of stability data presentations for various key stakeholder meetings.
- Preparing written summaries of data analyses including figures, tables, as needed for technical reports, scientific papers and patent application.
- Documentation: Maintain thorough and accurate records of laboratory work
- Ensure good scientific and technical leadership within the group, keep updated with current developments in relevant scientific and technical disciplines.
- Communication: Effectively communicate investigation findings and progress to both internal teams and external stakeholders as necessary.
- Collaborate with external Contract Development Manufacturing Organizations (CDMOs) to facilitate the testing of stability samples, providing essential support for investigative processes.
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- Ph.D. or Master's degree in a relevant scientific field (e.g., pharmaceutical sciences, biophysics, biochemistry, or related discipline) is preferred.
- At least 3-5 years of experience in vaccine analytical development and/or vaccine stability program development
- Strong analytical skills, with proficiency in a range of analytical techniques
- Strong scientific leadership is required: critical thinking, ability to present complex data sets and to independently propose and design follow-up experiments.
- The candidate should have high degrees of both flexibility and organizational skills as well as an eagerness and ability to learn in order to effectively navigate multiple projects and timelines.
- Strong interpersonal skills: ability to communicate effectively both verbally and in written formats (must be able to work with managerial and lab team in remote setting when needed) are necessary to collaborate effectively with the rest of the Analytical Development and Quality Control team, and well as across other teams.
- Detail oriented, rigorous and excellent skills in record keeping/documentation.
- All employees require vaccination against COVID-19.