GMP Analytical Chemist

Eurofins USA PSS Insourcing Solutions•Groton, CT

About The Position

The GMP Analytical Chemist uses analytical methodologies, systems, and processes to support GMP release and stability testing of clinical supplies for drug substances and drug products throughout all phases of development. Work may also support excipients, packaging, and post-packaging activities. Analytical testing may include compendial testing, such as excipient and packaging release testing; disintegration and dissolution; HPLC/UPLC and SFC; generic testing such as solvents, water, ash, titrations, heavy metals, ICP/MS, and UV; and compound-specific methods. The role also involves setting up and analyzing drug substance and drug product stability samples, as well as developing and validating analytical methods for drug substances and drug products. The position requires working in a GLP or GMP environment while following appropriate documentation and safety practices. It is Monday through Friday, 8 a.m. to 5 p.m., with overtime as needed. Weekend, overtime, and holiday work may be requested based on business needs. Candidates living within commuting distance of Groton, Connecticut, are encouraged to apply.

Requirements

Experience with GMP, wet chemistry, HPLC, Raman, and FTIR.
Bachelor’s degree in science or a related degree concentration, or equivalent directly related experience.
Strong computer, scientific, and organizational skills.
Excellent oral and written communication skills and attention to detail.
Ability to work independently and as part of a team.
Self-motivated, adaptable, and 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 in a GMP laboratory, preferably in analytical chemistry.
Experience with eLN, LIMS, and data trending.

Responsibilities

Support GMP release and stability testing of clinical supplies for drug substances and drug products throughout all phases of development.
Provide analytical support for excipients, packaging, and post-packaging activities as needed.
Perform analytical testing, including compendial testing, disintegration, dissolution, HPLC/UPLC, SFC, generic testing, and compound-specific methods.
Set up and analyze drug substance and drug product stability samples.
Develop and validate analytical methods for drug substances and drug products.
Follow appropriate documentation and safety practices in a GLP or GMP environment.