Manager, Analytical Development – Biologics- Eurofins CDMO Alphora Inc.

Manager, Analytical Development – Biologics- 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.

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 CDMO Alphora Inc. develops and manufactures new therapeutics to improve the lives and health of patients.

The Manager, Analytical Development is accountable to the Vice President, Biologics to lead and oversee the analytical development and testing activities, including planning and execution of technology/method transfer, early/late-stage method development/testing within the Biologics Business Unit to meet the business objectives.

Duties and Responsibilities:

• Establish an open-for-business analytical development lab (Biologics)
• Establish technology transfer requirements, analytical method development and testing plans for Eurofins CDMO Alphora clients.
• Serve as an SME for analytical development and testing (Biologics, focusing on mAbs).
• Write/Review/Approve Standard Operating Procedures related for analytical equipment and activities.
• Ensure a clear and transparent communication internally and with Alphora’s clients.
• Follow Environmental, Health and Safety rules/regulations, establish safety procedures within the analytical space and report any workplace injuries or accidents immediately.
• Train and mentor junior team members to assist in their development, providing knowledge transfer, hands-on technical training, modeling best practices, and setting priorities and clear expectations.
• Responsible for compliance with relevant guidelines and standards for Development and Manufacturing in Pharmaceutical Industry (IP, ICH, USP and HSE).

Minimum Requirements:

• University degree (PhD or MSc) in biochemistry, biotechnology, analytical chemistry, Pharmaceutical Technology or a related field.
• 5+ years of industry experience in analytical testing, development, qualification/validation and troubleshooting (biologics).
• Experience working in a GxP analytical environment
• Extensive experience in method development using techniques such as chromatography (e.g., SEC, RP-HPLC, IEX), and capillary electrophoresis (e.g., iCIEF, CE-SDS), spectrophotometry, ELISA and other biophysical and biochemical methods for biologics.
• Experience with antibodies and/or antibody-drug conjugates is an asset.
• Experience managing and conducting stability programs, including real time, accelerated/forced degradation, and freeze thaw studies.
• Experience in people management and establishment of high performing teams.
• Familiarity with regulatory and analytical guidelines, including strong knowledge of cGMPs, ICH, FDA, USP and other relevant global regulatory requirements is a plus.
• Previous experience with filing or working on IND and/or CTA filings is a plus.

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.

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.