Analyst II, Analytical Development – Biologics

Job type:; Mississauga; In loco; CAD 59.000 - 72.000; Tempo pieno

Descrizione del lavoro

Eurofins CDMO Alphora Inc. seeks an Analyst II, Analytical Development to support technology transfer, method development, qualification, and validation of analytical methods for biologics characterization and testing.

You will plan and execute experiments for early to late‑stage programs, collaborate with QC, Formulations, Process Development, and external partners, and contribute to continuous improvement and regulatory support.

Competenze

• Master’s degree in Analytical chemistry, pharmaceutical chemistry, Organic chemistry, Medicinal chemistry, Biochemistry, or biological science with at least 1 year of relevant experience.
• Bachelor’s degree in Analytical chemistry, pharmaceutical chemistry, Organic chemistry, Medicinal chemistry, Biochemistry, or biological science with at least 3 years of relevant experience.
• Comprehensive understanding of analytical techniques to support the analysis and characterization of biologics.
• Proven experience and technical expertise in the development and validation of separation methods (e.g., HPLC, LC-MS, CE) including proficiency in Empower 3 software is essential.
• Hands‑on experience in developing and qualifying bioassays, including receptor‑binding and cell‑based assays is an asset.
• In‑depth understanding of analytical development strategy to support regulatory filing.
• Proven ability to design and plan experiments, prioritize tasks and critically evaluate results under compressed timelines.
• Outstanding written and verbal communication skills, with the ability to convey strategies and results to a diverse audience.
• Strong interpersonal skills and ability to work collaboratively as a member of a cross‑functional team.
• Excellent communication, GMP documentation, and organizational skills.
• Strong problem‑solving skills.

Mansioni

• Apply analytical methodologies to support testing and characterization of biopharmaceuticals, including mAbs, ADCs, fusion proteins, and recombinant proteins.
• Lead analytical method transfers, method development, and validation for drug substance and drug product.
• Plan, conduct, troubleshoot, and document laboratory studies independently while ensuring scientific integrity and quality.
• Clearly communicate data, insights, and recommendations to project teams and larger audiences.
• Develop, optimize, and validate robust analytical separation methods and bioassays to characterize and quantify biologics.
• Collaborate with internal and external partners to support biophysical characterization activities.
• Adhere to GMP and GDP standards in all analytical work.
• Write and review SOPs and work instructions for analytical and lab‑related activities.
• Work cross‑functionally to drive project timelines and deliverables.
• Contribute to continuous improvement initiatives and provide technical insight to resolve project challenges.
• Mentor junior team members through training, guidance, and feedback.
• Follow EHS guidelines, ensuring safe laboratory operations.
• Support lab operations including equipment maintenance, supply management, and sample shipments.

Conoscenze

Analytical development

Method transfer

Validation assays

Regulatory support

Cross-functional teamwork

Formazione

Master’s in Analytical Chemistry

Bachelor’s in Analytical Chemistry

Strumenti

Empower 3

HPLC

LC-MS

Descrizione del lavoro

Join Our Team and Help Shape the Future of Biologics!

Are you passionate about advancing innovative biologic therapies? Do you thrive in a dynamic environment where scientific rigor, collaboration, and problem‑solving are at the forefront?
We’re looking for an Analyst II, Analytical Development to support technology transfer, method development, qualification, and validation activities within our growing biopharmaceutical analytics group.

The Analyst II, Analytical Development, is accountable for supporting technology transfer, method development, qualification, and validation of analytical methods for the characterization and analytical testing of biologics. The successful candidate will play a key role in planning and executing experimental work to generate data and prepare technical reports for early‑stage research, preclinical development, or late‑stage CMC programs across various drug modalities.

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, motivated technologists, and 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 push the boundaries of scientific research and provide hope to our most vulnerable.

What You Will Achieve in This Role

In this position, you will:

• Become a key contributor to analytical strategies supporting cutting‑edge biologic programs.
• Build deep expertise in method development, validation, and the analytical characterization of complex molecules.
• Lead analytical activities that directly inform decisions in process development, regulatory submissions, and tech transfers.
• Strengthen cross‑functional collaboration by working closely with QC, Formulations, Process Development, and external partners.
• Help shape best practices, drive continuous improvement, and influence the evolution of Analytical Development capabilities within the organization.
• Advance your career through hands‑on technical challenge, exposure to diverse modalities, and mentorship opportunities.

This role is perfect for someone who wants to see their work make a measurable impact across the full lifecycle of biologic development.

Core Responsibilities

• Apply a strong understanding of analytical methodologies to support the testing and characterization of biopharmaceuticals, including monoclonal antibodies, ADCs, fusion proteins, and recombinant proteins.
• Lead and execute analytical method transfers, method development, and validation for drug substance and drug product.
• Plan, conduct, troubleshoot, and document laboratory studies independently while ensuring scientific integrity and quality.
• Clearly communicate data, insights, and recommendations to project teams and larger audiences; contribute to experimental design discussions.
• Develop, optimize, and validate robust analytical separation methods and bioassays to characterize and quantify biologics.
• Collaborate with internal and external partners to support biophysical characterization activities.
• Adhere to GMP and GDP standards in all analytical work.
• Write and review SOPs and work instructions for analytical and lab‑related activities.
• Work cross‑functionally to drive project timelines and deliverables.
• Contribute to continuous improvement initiatives and provide technical insight to resolve project challenges.
• Mentor junior team members through training, guidance, and feedback.
• Follow EHS guidelines, ensuring safe laboratory operations.
• Support lab operations including equipment maintenance, supply management, and sample shipments.

Why You’ll Be a Great Fit

• Bring strong foundational knowledge in analytical characterization of biologics (e.g., mAbs, ADCs, fusion proteins, recombinant proteins).
• Enjoy solving complex scientific problems and designing efficient laboratory strategies.
• Communicate clearly and confidently, both in writing and when presenting data to broader teams.
• Thrive in a fast‑paced environment where adaptability, organization, and attention to detail matter.
• Are a collaborative team player who enjoys sharing knowledge, mentoring others, and contributing to a positive lab culture.
• Take pride in high‑quality documentation and compliance, understanding the importance of GMP/GDP in biologics development.
• Are proactive, curious, motivated by continuous improvement, and eager to push projects forward.

If you are someone who enjoys taking ownership, driving innovation, and applying critical thinking to real‑world therapeutic challenges, you’ll feel right at home here.

Qualifications

• Master’s degree in Analytical chemistry, pharmaceutical chemistry, Organic chemistry, Medicinal chemistry, Biochemistry, or biological science with at least 1 year of relevant experience
• Bachelor’s degree in Analytical chemistry, pharmaceutical chemistry, Organic chemistry, Medicinal chemistry, Biochemistry, or biological science with at least 3 years of relevant experience Comprehensive understanding of analytical techniques to support the analysis and characterization of biologics.
• Goodunderstanding of analytical techniques to support the analysis and characterization of biologics.
• Demonstrated experience and technical expertise in the development and validation of separation methods (e.g., HPLC, LC‑MS, CE) including proficiency in Empower 3 software is essential.
• Hands‑on experience in developing and qualifying bioassays, including receptor‑binding and cell‑based assays is an asset.
• In‑depth understanding of analytical development strategy to support regulatory filing.
• Proven ability to effectively and independently design and plan experiments, prioritize tasks and critically evaluate results under compressed timelines.
• Outstanding written and verbal communication skills, with the ability to convey strategies and results to a diverse audience.
• Strong interpersonal skills and ability to work collaboratively as a member of a cross‑functional team.
• Excellent communication, GMP documentation, and organizational skills.
• Strong problem‑solving skills.

The starting annual base compensation for this position is $65,000 CAD. The actual offer, reflecting the total compensation package plus benefits, will be determined by a number of factors which include but are not limited to the applicant’s experience, knowledge, skills, and abilities.

Disclaimer: Salary information posted on sites other than the official careers page does not reflect the organization’s compensation and may represent estimated ranges provided by third‑party job boards. The organization offers competitive wages and a comprehensive total rewards package, which will be discussed during the interview process.

At Eurofins CDMO Alphora, we leverage artificial intelligence (AI) technology to support our recruitment process, including preliminary screening of applications and resumes. All hiring decisions are made by human reviewers.

This posting is for a current vacancy and the successful candidate will start as soon as possible.

WHO ARE WE?

Eurofins CDMO Alphora Inc. provides a fully integrated suite of services to support drug substance and drug product development from the IND enabling development stage, through to phase II & III supply, and commercial validation and manufacturing for niche APIs. In addition to a continuing flow of interesting and challenging projects for global pharmaceutical and biotech companies, Eurofins CDMO Alphora Inc. is committed to growing its state‑of‑the‑art organization, with continued investments in its people, modern facilities, equipment, and instrumentation.

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 2022, Eurofins generated total revenues of EUR 6.7 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.

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 .