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Pharmaceutical Research & Development Faciity
posted about 2 months ago
Full-time - Mid Level
About the position
The Associate Principal Scientist in the Analytical R&D department will focus on analytical method development and validation for small molecule drug substances. This role involves conducting various analytical tests on oral solid dosage forms and supporting formulation development with analytical data.
Responsibilities
- Carryout method development and method validation of small molecules.
- Stability, assay and dissolution testing.
- Carry out routine and non-routine tests on API, excipients, in-process and finished products.
- Interact with and support formulation development scientists with analytical data.
- Perform 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 with analytical data.
- Experience in particle size analysis of APIs.
- Strong documentation skills for analytical testing protocols and reports.
Nice-to-haves
- Experience with HPLC and LCMS equipment.
- Familiarity with regulatory requirements in pharmaceutical development.
