Job Description
How You’ll Contribute:
This position is within the Analytical Development team of the Applied Research department. This role focuses on developing, validating, and transferring analytical methods to support small and large molecule drug development and formulations from early-stage clinical studies up to commercialization.
The position will establish, coordinate and monitor analytical related activities both internally and with CROs and CMOs to ensure quality and timeliness of projects. The position also involves overseeing stability studies and conducting trending analysis for drug substance and drug product. The ideal candidate works effectively and collaboratively with cross-functional groups and will represent as analytical lead on CMC project teams. This position is expected to communicate data both verbally at group meetings and through written documents and reports and be able to comfortably multitask across projects and disciplines.
What You’ll Do:
- Provides technical expertise to design, conduct, and implement analytical and development activities for large and small molecules to support all stages of drug development.
- Troubleshoots and solves technical challenges in a timely manner and ensures generation of high-quality scientific data.
- Evaluates and interprets data from release and stability studies and provides scientific conclusions.
- Maintains expertise in cutting-edge assay technologies used for the characterization of drug delivery systems for drug release, potency, stability, impurity testing and aggregation profile.
- Prepares high quality experimental protocols and technical reports in support of regulatory submissions. Supports authoring appropriate portions of CMC section of INDs, NDAs and prepares responses to regulatory questions.
- Represents as analytical lead on CMC project teams, provides scientific solutions and contributes to team discussions. Support QC department with establishing robust methods, product specifications, method validations and method transfers.
- Proactively develops and maintains knowledge in current analytical sciences and investigates new technologies, recommends and implements innovative techniques to the team.
How You’ll Get There:
- Strong hands-on knowledge of chromatographic theory and technology.
- Working knowledge of HPLC, UPLC, GC, LC-MS, UV/Vis, Dissolution and other common analytical techniques used to determine potency, purity, and in-vitro performance of drug substance and drug product.
- Ability to perform investigations and troubleshoot technical problems at all stages of development, being detail oriented are important attributes.
- Excellent written and verbal communication skills; prior experience working within regulated environments (e.g., GMP, ICH, FDA) to ensure analytical activities meet compliance standards and support regulatory filings and inspections.
- Strong ability and knowledge to develop, validate and transfer methods. Experience in oversight of stability studies, conducting trend analysis and interpreting data.
- Ability to work within a diverse workforce, scientific participation and collaboration with colleagues in industry, academia and regulatory agencies.
- Experience in interacting with pharmaceutical CROs and CMOs and providing guidance.
- Project management skills including the ability to manage multiple projects and evaluate project resource requirements. Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
- Good knowledge of drug development and product regulations.
- Ph.D. (with 3+ years) or M.S. (8+ years) in analytical chemistry, pharmaceutical chemistry, pharmaceutical sciences, or related scientific field and 3+ years of pharmaceutical industry experience in small or large molecule analytical development, and
- Salary Range: 97900. - 122400. plus rich package of bonus, benefits and more!
