GMP Analytical Chemist

Eurofins USA PSS Insourcing Solutions•Groton, CT

3d•Onsite

About The Position

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.

Requirements

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.
Bachelor’s degree in science or other related degree concentration, or equivalent directly related experience.
Strong computer, scientific, and organizational skills.
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.
Authorization to work in the United States indefinitely without restriction or sponsorship.

Nice To Haves

Experience with eLN, LIMS, and data trending is a plus.
Experience in a GMP laboratory, analytical chemistry preferred.
Experience with eLN, LIMS, and data trending.

Responsibilities

Utilize analytical methodologies, systems, and processes to support GMP release and stability testing of clinical supplies for drug substance and drug product.
Perform excipient, packaging, and post-packaging support testing.
Conduct 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 analyze drug substance and drug product stability samples.
Develop and validate analytical methods for drug substance and drug product.