Principal Scientist - Analytical Testing

Description

The Principal Scientist will be responsible for performing advanced laboratory testing of raw materials and formulations for characterization and acceptability. This role requires proven expertise in modern instrumentation, such as HPLC/UPLC-MS, GC-HS, GC-MS, UV-Vis and ICP-MS, as well as complimentary wet chemistry and physical attribute tests. Additional exposure and experience to techniques, such as GPC and Ion Chromatography, applications, such as trace analysis, impurities and extractables / leachable testing, and computer system validations, are highly desirable.

Must have knowledge and familiarity with FDA regulations, ICH Guidelines and compendial requirements, including USP/NF monographs. This position requires hands-on experience working in regulated laboratory environments, such as in cGMP and/or ISO/IEC 17025. Must have excellent communication skills for discussing and reporting analytical test results and status to peers and lab management. The successful candidate will be detail-oriented, organized, and capable of managing multiple priorities while ensuring strict adherence to laboratory quality systems.

The Principal Scientist will lead efforts around advanced analysis and characterization of raw materials, R&D formulations and impurities. This role provides scientific and strategic leadership in ensuring quality and compliance. The position is accountable for performing testing in alignment with USP/NF Monographs and other global compendial standards. The role requires driving innovation in method development and validation, while providing technical leadership and guidance to junior scientists. This position is also responsible for ensuring data integrity, documentation, and communication of results, with timely escalation of critical issues to management and stakeholders.

As a key technical leader, the Principal Scientist will collaborate closely with cross-functional partners, providing expertise in analytical chemistry to influence qualifications of raw materials and regulatory compliance for formulations. They will act as a mentor to laboratory staff, fostering technical growth, scientific excellence, and a culture of compliance operating under cGMP and ISO/IEC 17025 standards.

Works independently with minimum supervision to evaluate raw materials and R&D formulations. Improves and develops new methods for efficiency and enhancement (80%).

Prepares reports, distributes results and engages with management, brands, and other stakeholders to solve their needs (20%).

Qualifications

• Bachelor’s degree in Chemistry required; Master’s or Ph.D. preferred.  
•  5 – 10 years of relevant industry experience.
• Demonstrated expertise in analytical instrumentation, including HPLC/UPLC, GC, GC-MS, UV-Vis, and ICP-OES/MS, with hands on experience in wet chemistry and physical property testing.
• Experience with ion chromatography, XRD, Raman spectroscopy, and related advanced techniques is highly desirable.
• Proven experience working in regulated laboratory settings, such as cGMP and ISO/IEC 17025 environments.
• Strong background in impurities testing, extractable/leachable testing, and computer system validations.
• Comprehensive knowledge of FDA regulations, ICH guidelines, and compendial standards, including USP/NF monographs.
• Ability to manage multiple critical processes and projects concurrently, ensuring on‑time, high‑quality analytical results for global functions, stakeholders, and regulatory submissions.
• Drive and initiative to solve complex problems. Strong problem‑solving skills, including the ability to think creatively and address complex technical challenges while meeting dynamic business needs.
• Exceptional organizational skills, attention to detail, and commitment to data integrity.
  Collaborative team player with excellent communication skills and the ability to work effectively with chemists, cross‑functional partners, and management.