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

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.

DUTIES AND RESPONSIBILITIES:

• 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.

Within the Company

Interact with all staff throughout the company as necessary to implement the business objectives.

Outside of the Company

Interact with various outsource vendors, clients, contractors, and industry bodies to support the business objectives.

• B.Sc. or M.Sc. in Chemistry with >10 years experience or Ph.D in Chemistry with >5 years experience in the pharmaceutical-related field industry
• Must have a strong knowledge of drug product development and hands-on experience in analytical development
• Must be highly motivated and have a proven record of success in multiple projects
• Must be well organized and able to meet project timeline commitments
• Must work well in a multi-disciplinary team environment and have excellent written and verbal communication skills

At Eurofins we offer excellent full-time benefits including health & dental coverage, life and disability insurance, RRSP with 3% company match, paid holidays, paid time off.

Accommodation: Persons with disabilities who need accommodation in the application process, or those needing job postings in an alternative format, may e-mail a request via the website at www.eurofins.ca.

As a Eurofins employee, you will become part of a company that has received international recognition as a great place to work. To learn more about Eurofins, please explore our website at www.eurofins.ca

We thank all applicants within commuting distance of GTA, Ontario for showing an interest in this position. Only those selected for an interview will be contacted.

NO AGENCIES, CALLS OR EMAILS PLEASE