Senior Research Chemist (Drug Product) - Eurofins CDMO Alphora, Inc.

at  Eurofins Canada BioPharma

IN 2022, EUROFINS GENERATED TOTAL REVENUES OF EUR 6.7 BILLION, AND HAS BEEN AMONG THE BEST PERFORMING STOCKS IN EUROPE OVER THE PAST 20 YEARS.

Eurofins CDMO Alphora Inc. develops and manufactures new therapeutics to improve the lives and health of patients. Eurofins CDMO Alphora provides contract research & development services to global pharmaceutical and biotech companies, developing their processes and manufacturing their bulk drug substances (Active Pharmaceutical Ingredients -“API’s”) as well as finished dosage products (tablets, capsules, suspensions) for supply to clinical trials and commercial requirements. Eurofins CDMO Alphora provides a rich and technologically challenging environment with a continuing flow of interesting projects. Our employees work in close concert with clients throughout the development process to achieve their program objectives. Eurofins CDMO Alphora Inc. is growing its state-of-the-art organization, with continued investments in modern facilities, equipment, and instrumentation while providing a rich environment for employees to develop their technical skills and careers paths.
Job Description
The Sr. Research Chemist will be responsible for overseeing and executing analytical services in support of Drug Product development and GMP operations. Primary responsibilities will include analytical services such as method transfer, method development and phase appropriate method validation. The Sr. Research Chemist will also support QC drug product release, stability and any required investigations. The Sr. Research Chemist may also be responsible for direct reports as required.

• Draft GMP documentation such as test methods, material/product specifications, protocols, and SOP’s as required.
• Develop and execute analytical methods in support of oral drug product development. Methods include but are not limited to Assay, Impurity, Dissolution, Water Content, and Residual Solvent.
• Conduct OOT/OOS/Deviation investigations as required.
• Troubleshoot, maintain and perform equipment qualifications for HPLC’s, GC’s, KF and other analytical equipment as required.
• Conduct prototype and GMP stability studies in accordance with ICH or other regulatory guidelines.
• Ensure all work is performed in compliance with applicable SOP’s, cGMP’s, and GLP’s.
• Promote and maintain a safe and healthy working laboratory environment in compliance with established health and safety procedures.
• Other duties as assigned.