Senior Analytical Chemist at Alkem Laboratories in Fenton, Missouri

Job Description:

Function: The Senior Analytical Chemist will coordinate with other Quality Control chemist, R & D
Researchers and formulation specialist and other manufacturing departments to ensure high quality standards are always met.

Primary Responsibilities and Essential Functions of the Position:

Follow cGMP, cGLP, and OSHA guidelines regarding work practices and safety.
Analyze raw, intermediate, final product, and stability samples per In-house test methods or compendial guidelines.
Lead project teams as assigned by the Manager-Analytical Chemistry.
Train laboratory personnel in use of equipment and analytical techniques.
Solve complex analytical problems.
Take part in laboratory investigations as needed.
Draft study protocols and reports as needed.
Qualify, calibrate, and maintain laboratory equipment.
Write, review, and revise SOPs as required.
Review and revise laboratory systems on an ongoing basis.
Peer review data and reports.
General laboratory maintenance.
Other duties, which may be assigned from time to time, by the Executive Management of the Company.

Skills and Abilities Required:

Bachelor's degree in Chemistry with a minimum of ten (10) years of laboratory experience; or
Master's degree or PHD with a minimum of five years (5) laboratory experience.
Capable of preparing cGMP and other laboratory documents.
Excellent knowledge of computer systems and software.
Good knowledge pf cGMP and FDA regulations.
Excellent interpersonal, organizational, and communication skills.

Physical Requirements:

Some lifting <35lbs.
In accordance with FDA regulations (21 CFR § 211.28), individual must be free from illness that could jeopardize the safety or quality of products. Such illnesses may include, but are not limited to, illnesses that cause bleeding, open lesions, flaking or peeling skin.

Work Environment:

GMP Manufacturing and Laboratory Environment.
May be exposed to laboratory chemicals and solvents.