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

Company Description

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. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2023, Eurofins generated total revenues of EUR 6.515 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.

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.

COMMUNICATION AND CONTACTS:

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.

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 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

Additional Information

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