We are seeking a highly motivated, detail-oriented analytical chemist to join our CMC team as an Associate Scientist Analytical Development & Quality Control (AD & QC). The successful candidate will report to Senior Scientist, CMC and will work with the internal and external AD/QC teams to develop, transfer and qualify test methods that will enable mRNA therapeutic development. He/or She will effectively and routinely collaborate with colleagues from Research and Process Development teams to support process development activities. The ideal candidate should be able to contribute to support regulatory submissions.
- Assist in technical review of analytical development supporting documents including protocols, reports and CMC sections for regulatory filings.
- Work with CMO’s/CRO’s on technology transfer of assays to support development and CMC.
- Analyze stability studies for Drug Substance and Drug Product.
- Assist in the execution of analytical development experiments to improve platform analytics capabilities.
Key Skills and Competencies
- Knowledge of CMC product development process including, cGMP manufacturing, validation, process development. Previous experience/knowledge of routine mRNA productions and testing in support of Process Development and Research activities is preferable, but not required
- Knowledge of GMP/ICH/FDA regulations is required.
- Demonstrated competency and hands-on experience of typical chemistry manufacturing and controls (CMC) activities.
- Familiarity with a full range of analytical techniques for characterization of pharmaceuticals including RP/IEX/SEC HPLC, UPLC, LCMS, Karl Fisher, solid state characterization, CE spectrophotometry.
- Organized, motivated, diligent, calm under pressure and able to work with multiple personality types.
- Good attention to detail.
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
- Strong oral and written communication skills.
- Ability to manage multiple projects and studies effectively.
- Reviews, interprets and communicates data cross-functionally within CMC and project teams.
- Ability to meet deadlines and demonstrate effective use of time.
- Ability to be flexible and responsive to change, and be a results-driven problem solver.
- B.S with minimum of 5 years or MS with 3+ years of experience pharmaceutical chemistry, biochemistry. Degree emphasis in Analytical Chemistry is preferred.
- Previous experience in analytical development or quality control is required, preferably within a pharmaceutical company setting or a CRO.
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