Job Description
Duties and Responsibilities:
- Perform analytical testing (e.g., HPLC/UPL) of drug products.
- Perform data analysis (chromatography/spectroscopy) and present them to the team in a timely manner.
- Execute analytical method validation.
- Execute forced degradation studies on drug products.
- Complete work effectively to meet timelines (both independently and in a team setting); demonstrated time management skills.
- Work safely and responsibly in a laboratory setting (be a good lab steward and co-worker).
- Communicate effectively with co-workers, managers and supervisors (status updates, obstacles and concerns).
- Technical reviewing and writing (SOPs, protocols, completion reports).
Education:
- BS or MS or PHD in Chemistry or related discipline.
Experience and Skills:
- Hands-on analytical laboratory experience (wet chemistry techniques, pipetting with volumetric pipettes, preparing solutions in volumetric glassware, pH measurements, titration, dilution, etc.)
- Expertise in Liquid Chromatography (HPLC/UPLC) with working knowledge of Empower software.
- Experience collecting and analyzing raw data, preparing graphs and other visualization tools to help interpret results.
- Familiarity with basic statistical analysis (working knowledge of statistical tools for data treatment using Excel or Minitab).
- Experience performing Forced Degradation Studies.
- Experience performing analytical method validation.
- Working knowledge of laboratory GMP, quality, compliance and data integrity requirements and related industry trends.
- Working knowledge of troubleshooting analytical techniques (e.g., chromatography, dissolution, spectroscopy, etc.)
- Demonstrated ability to work independently in the laboratory.
- Experience conducting comparative and/or multimedia dissolution studies is a plus.
- Experience using electronic laboratory notebook software is a plus.
- Demonstrated strong verbal and written communication skills, and an ability to work in an interdisciplinary team environment.
- Demonstrated ability to adhere strictly to safety procedures and protocols.