A Senior Principal Scientist in Analytical Research and Development plays an important role during all phases of pharmaceutical development. The qualified candidate will take an active role by leading the analytical development strategies and performing and directing lab work for new drug candidates. The candidate will work with cross-functional development teams and apply a variety of analytical methodologies to support physical and chemical characterization of drug substances and products. The candidate should be proficient with a breadth of analytical methodologies (e.g. chromatography, mass spectrometry, dissolution, spectroscopy, and NMR), with expertise in one or more techniques. The candidate should also be proficient with a wide-variety of software and information systems and have a demonstrated ability to learn new techniques and solve complex analytical problems. Experience with mathematical modeling or coding is also desired.Role Responsibilities
- As a project analyst, the candidate will be responsible for developing analytical strategies in support of pharmaceutical drug products during all development phases, including supporting manufacturing process development, developing, validating and transferring analytical methods, designing stability studies to understand drug degradation mechanisms and for shelf life assignments, and developing impurity control strategies.
- The candidate will perform lab work and will plan, direct, and review the lab work of other scientists in a matrix environment.
- The role requires collaboration with colleagues to identify appropriate analytical approaches, including use of computational predictive tools, modeling software and data visualization tools where appropriate.
- The candidate will critically review and Interpret scientific data to derive clear conclusions and provide direction for future work and will communicate results and conclusions through various media including presentations and technical reports.
- As a subject matter expert, the candidate will evaluate new approaches, instrumentation or analytical technologies and mentor other scientists.
- The candidate will author relevant sections of the quality modules of regulatory submissions.
- Ph.D in Analyical Chemistry or related field, with 7+ years of pharmaceutical R&D experience required
- Demonstrated oral and written communication skills, including visualization of data, presentations and authoring technical articles.
- Demonstrated ability to meet timelines and interact with multi-disciplinary teams
- Demonstrated ability to learn new techniques and solve complex analytical problems.
- Attention to detail, strong organizational skills, and effective interpersonal and communication skills are required.
- Proficient with a wide variety of software and information systems.
Other Job Details:
- Working knowledge and the ability to operate analytical techniques such as HPLC-MS, GC-MS, spectroscopy, and physical techniques such as particle size and dissolution that are commonly used for the characterization of pharmaceutical substances and products is desired.
- Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
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Research and Development