Title: QC Analyst/Chemist
Location: Summit, NJ
Duration: 6 Months (possible extensions)
The Associate Scientist plays an important but supporting role throughout the development of new drug candidates from discovery to commercialization, contributing to the advancement of new therapeutics.
Responsibilities for an Associate Scientist include, but are not limited to, the following:
- Contributes to the development of priority drug candidates through the development, validation, and implementation of analytical methods involving modern analytical instrumentation including HPLC/UPLC, GC, dissolution, FT-IR, Karl Fischer titrations, etc.
- Transfers validated methods to customer labs, including internal and partner-owned quality control (QC) labs.
- Performs testing for development and clinical materials and stability samples in accordance with established methods, specifications and protocols under supervision.
- Knows the fundamentals of analytical methodology and can troubleshoot instrumentation and method performance issues of routine complexity.
- Documents / reviews laboratory work using laboratory notebooks / worksheets that is detailed, timely and in compliance with GLP / GMP requirements.
- Contributes data to the preparation of high-quality technical reports as source documents for regulatory submissions.
- Reviews data for compliance and adherence to specifications and acceptance criteria.
- Communicates results according to project timelines and works with collaborators to understand project needs and contribute to overall analytical control strategy.
- Draws basic conclusions from data and results.
- Complies with Environmental Health and Safety Requirements
- Other duties as assigned by supervisor.
Skills / Knowledge Required:
- BS/MS Chemistry (or relevant discipline).
- Minimum 3 years cGMP / GLP pharmaceutical laboratory experience
- Hands-on experience with separations techniques (HPLC, UPLC, GC, etc.)
- Familiar with HPLC, dissolution, FT-IR, UV/VIS spectrophotometry, titrations, etc.
- Experience in laboratory investigation and documentation of Out-of-Specification results.
- Experience in the development and performance of analytical tests for a variety of drug substances and products (including solid oral dosage forms and injectables) is a plus.
Sthree US is acting as an Employment Business in relation to this vacancy.