Analytical Scientist- Associate Principal

Pharmaceutical Research & Development Faciity - Middlesex, NJ

Full-time - Mid Level

Middlesex, NJ

About the position

The Associate Principal Scientist position in the Analytical R&D department focuses on analytical method development and validation for small molecule drug substances. The role involves conducting various analytical tests and supporting formulation development scientists with analytical data, ensuring compliance with documentation standards and maintaining laboratory equipment.

Responsibilities

• Carry out method development and method validation of small molecules.
• Conduct stability, assay, and dissolution testing.
• Perform routine and non-routine tests on API, excipients, in-process, and finished products.
• Interact with and support formulation development scientists with analytical data.
• Conduct particle size analysis of APIs.
• Maintain appropriate documentation of analytical testing including protocols, specifications, reports, and SOPs.
• Maintain inventory of API-related materials.
• Work closely with and guide junior-level scientists.
• Maintain balance, pH meter, dissolution apparatus, HPLC, LCMS, and similar equipment.
• Follow instructions from the global head of R&D.

Requirements

• Experience in analytical method development and validation for small molecules.
• Proficiency in stability, assay, and dissolution testing.
• Knowledge of routine and non-routine testing on APIs and excipients.
• Ability to interact and support formulation development scientists.
• Experience with particle size analysis of APIs.
• Strong documentation skills for analytical testing protocols and reports.
• Experience in maintaining laboratory equipment such as HPLC and LCMS.

Nice-to-haves

• Experience in a pharmaceutical research and development environment.
• Familiarity with oral solid dosage forms.