Senior Principal Scientist - Drug Product Analytical Research and Development

Role Summary

Senior Principal Scientist in Drug Product Analytical Research and Development responsible for leading analytical development strategies across all development phases, applying a range of analytical methodologies, collaborating with cross-functional teams, and mentoring scientists to support physical and chemical characterization of drug products.

Responsibilities

• As a project lead, develop analytical strategies in support of pharmaceutical drug products during all development phases, including manufacturing process development, developing, validating and transferring analytical methods, designing stability studies, shelf-life assignments, and impurity control strategies.
• Plan, direct, and review laboratory work and supervise other scientists in a matrix environment.
• Collaborate with colleagues to identify analytical approaches, including use of computational predictive tools, modeling software, and data visualization where appropriate.
• Critically review and interpret scientific data to derive clear conclusions and provide direction for future work; communicate results through presentations and technical reports.
• As a subject matter expert, evaluate new approaches, instrumentation or analytical technologies and mentor other scientists.
• Author relevant sections of the quality modules of regulatory submissions.

Qualifications

• Required: Ph.D. in Analytical Chemistry or related field, with 8+ years of pharmaceutical R&D experience.
• Required: Demonstrated oral and written communication skills, including data visualization, presentations, and authoring technical articles.
• Required: Demonstrated ability to meet timelines and interact with multi-disciplinary teams.
• Required: Demonstrated ability to learn new techniques and solve complex analytical problems.
• Required: Attention to detail, strong organizational and interpersonal skills; proficient with a wide variety of software and information systems.
• Preferred: Working knowledge of HPLC-MS, GC-MS, spectroscopy, and physical techniques such as particle size and dissolution for characterization of pharmaceutical substances and products.
• Preferred: Leadership experience including influencing peers, coaching, and guiding others to achieve meaningful outcomes and business impact.

Education

• Ph.D. in Analytical Chemistry or related field (as listed under Required).

Skills

• Analytical chemistry techniques (chromatography, mass spectrometry, dissolution, spectroscopy, NMR).
• Data analysis, interpretation, and visualization; cross-functional collaboration; regulatory documentation.
• Software and information systems proficiency; ability to learn new techniques.

Additional Requirements

• Occasional travel may be required.
• Relocation support available.
• Work location: On Premise.
• Note: Excluded compensation details and non-essential corporate disclosures.