Scientist II (Separation Science), Analytical Development - Biologics - Eurofins CDMO Alphora, Inc
Eurofins View all jobs
- Mississauga, ON
- Permanent
- Full-time
- Apply strong analytical understanding to support the testing and characterization of biopharmaceuticals, including monoclonal antibodies, ADCs, fusion proteins, and recombinant proteins.
- Serve as a Subject Matter Expert (SME) in analytical development and testing, offering strategic and technical guidance.
- Lead and perform analytical method transfer, method development, and method validation for both drug substances and drug products.
- Independently plan, execute, troubleshoot, and report laboratory work with minimal supervision.
- Clearly communicate results to internal teams and external clients, and actively support the design of subsequent studies.
- Develop, optimize, and validate robust analytical separation methods to quantify and characterize biologics.
- Manage internal collaborations and external partners responsible for biophysical characterization activities.
- Ensure all analytical activities adhere to GMP and GDP standards with strong documentation practices.
- Write, review, and approve SOPs and work instructions related to analytical procedures and laboratory operations.
- Lead or participate in quality event investigations (planned and unplanned), recommending effective corrective and preventive actions.
- Collaborate across multidisciplinary teams to advance projects and provide analytical expertise.
- Drive continuous improvement initiatives and contribute to timely resolution of analytical issues or gaps.
- Train, mentor, and support junior team members through knowledge transfer, hands-on training, and clear guidance.
- Support daily laboratory operations, including equipment maintenance, supply ordering, and coordinating shipments of materials or samples.
- High-impact work: Your analyses directly influence decision-making across early research, development, and CMC stages.
- Meaningful scientific contribution: You'll work on diverse biologic modalities and cutting-edge technologies.
- Growth and development: Exposure to a wide range of analytical techniques, mentorship opportunities, and cross-functional project involvement.
- Supportive team culture: Work alongside skilled scientists who value collaboration, learning, and continuous improvement.
- Autonomy and ownership: You will have the freedom to lead methods, drive investigations, and shape analytical strategy.
- Commitment to quality: A strong GMP environment where scientific excellence and compliance go hand in hand.
- Ph.D degree in Analytical chemistry, pharmaceutical chemistry, Organic chemistry, Medicinal chemistry, Biochemistry, or biological science with at least 3 years of relevant experience
- Master's degree in Analytical chemistry, pharmaceutical chemistry, Organic chemistry, Medicinal chemistry, Biochemistry, or biological science with at least 5 years of relevant experience
- Comprehensive understanding 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, etc) including proficiency in Empower 3 software are required.
- 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.