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Eurofins Humangenetik & Pränatal-Medizin
Senior Research Chemist (Drug Product) – Eurofins CDMO Alphora, Inc.
- Full-time
Eurofins Scientific is an international life sciences company providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labeling is accurate.
In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralized and entrepreneurial network of ca. 900 laboratories in 61 countries.
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 for supply to clinical trials and commercial requirements.
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.
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.
Minimum Qualifications:
- 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.
- Strong knowledge of drug product development and hands-on experience in analytical development.
- Highly motivated with a proven record of success in multiple projects.
- Well organized and able to meet project timeline commitments.
- Ability to work well in a multi-disciplinary team environment with excellent written and verbal communication skills.
Benefits:
At Eurofins we offer excellent full-time benefits including health & dental coverage, life and disability insurance, RRSP with 3% company match, paid holidays, and 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.
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.
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