Scientist II (Bioassay), Analytical Development - Biologics - Eurofins CDMO Alphora, Inc
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- Mississauga, ON
- Permanent
- Full-time
- Applying strong analytical knowledge to support the testing and characterization of monoclonal antibodies, ADCs, fusion proteins, and native/recombinant proteins.
- Serving as a Subject Matter Expert (SME) in analytical development and testing, providing technical leadership across programs.
- Leading and executing analytical method transfers, method development, and validation for drug substances and drug products.
- Planning, implementing, troubleshooting, and reporting on laboratory projects with independence and minimal supervision.
- Presenting data clearly to internal teams and external clients, while contributing to experimental strategy and next-step design.
- Developing, optimizing, and validating robust bioassays for quantifying and characterizing biologics.
- Managing internal collaborators and external partners to complete biophysical characterization activities.
- Ensuring all work adheres to GMP and GDP requirements with strong documentation practices.
- Writing, reviewing, and approving SOPs and work instructions related to analytical methods, laboratory operations, and equipment.
- Leading or participating in the resolution of quality events, providing well-supported corrective and preventive actions.
- Collaborating across functional groups to advance project timelines and provide analytical technical guidance.
- Driving continuous improvement initiatives and supporting rapid resolution of analytical gaps and issues.
- Training and mentoring junior team members through knowledge transfer, hands-on support, and setting clear expectations.
- Supporting lab operations through equipment upkeep, supply management, and coordinating material or sample shipments.
- High-impact work that directly influences biologics development, regulatory submissions, and project success.
- A collaborative, science-driven culture where your expertise is valued and your ideas help shape analytical strategy.
- Opportunities to lead-from developing methods to mentoring team members and managing external partners.
- Continuous development, with exposure to diverse modalities, advanced testing technologies, and cross-functional projects.
- A supportive environment that prioritizes quality, innovation, teamwork, and professional growth.
- Hands-on involvement in both routine and complex analytical challenges, keeping your work varied and engaging.
- 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 developing and validating bioassays, including receptor-binding and cell-based assays, is essential.
- 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.