Manager, Analytical Development – Biologics

Job type: Full-Time
Accepting BioReady™: Yes
Category: Research and Development
Education: Ph.D.
Experience: 7-10 Years
Location: Mississauga, ON
Posted: February 3, 2025
Closes: March 5, 2025
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Eurofins CDMO Alphora has expanded its capabilities with our NEW – Biologics facilities and we are looking for an Analytical Development Manager to lead our growing Analytical team!

WHO ARE WE?

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. 

 

At Eurofins CDMO Alphora Inc., our mission is to harness the power of biotechnology and bioprocessing to create innovative complex medicines that will improve the lives of patients worldwide. With a dedicated team of experienced scientists, technologists, and a novel state-of-the-art process development (PD) facility, we are thrilled to be at the forefront of the biopharmaceutical CDMO industry in Canada. Join us on this exciting journey as we make waves in the Canadian biomanufacturing sector. 

Job Description

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).

Qualifications

  • 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.
  • Excellent communication skills 

 

To learn more about CDMO visit the website at www.eurofins.com/cdmo

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.

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.

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.

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