GMP Analytical Chemist

Ability to work in a GLP or GMP environment with appropriate documentation and safety practices.
Experience with GMP, wet chemistry, HPLC, Raman, FTIR are required
Responsible for utilizing analytical methodologies, systems, and processes to support GMP release and stability testing of clinical supplies for drug substance and drug product, throughout all phases of development. This may include excipient, packaging, and post-packaging support.
Analytical testing would include: compendial testing (e.g., excipients/packaging release testing), disintegration, dissolution, HPLC/UPLC, SFC, generic testing (e.g., solvents, water, ash, titrations, heavy metals, ICP/MS, UV), and compound-specific methods.
Set up and analysis of drug substance and drug product stability samples.
Method development and validation of analytical methods for drug substance and drug product
Bachelor’s degree in science or other related degree concentration, or equivalent directly related experience.
Strong computer, scientific, and organizational skills.
Experience with eLN, LIMS, and data trending is a plus.
Excellent communication (oral and written) and attention to detail.
Ability to work independently and as part of a team, self-motivated, adaptable, and a positive attitude
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
Preferred Qualifications:
Experience in a GMP laboratory, analytical chemistry preferred.
Experience with eLN, LIMS, and data trending.

Employment type
Full-time

Work arrangement
No