
Scientist, Analytical Development- Eurofins CDMO Alphora Inc
- Mississauga, ON
- Permanent
- Full-time
- Comprehensive understanding of testing with analytical instrument, bioprocessing, and industrial biotechnology
- Experience and good understanding of aseptic techniques in laboratory setting
- Basic understanding of how to implement Design of Experiments (DoE) and Quality by Design (QbD) in biopharmaceutical industry.
- Good understanding of Current Good Manufacturing Practices (cGMP) in biomanufacturing
- Leading projects, scientific communication, dealing with clients, etc.
- Strong documentation and technical writing skills, and able to apply relevant scientific principles and practices.
- Strong command over written and verbal English
- Able to work under minimal supervision and able to work independently and in a team environment.
- Able to exercise appropriate professional judgement on matters of significance.
- Proficient in computer skills and software applications such as MS tools
- Knowledge of statistical packages
- Must communicate clearly and concisely across levels, both orally and in written
- Proven ability to effectively and independently design and plan experiments, prioritize tasks and critically evaluate results under compressed timelines.
- PhD in chemistry, Biochemistry, or biological sciencewith 3 + years of relevant industry experience and quality control experience or Master's degree in chemistry, Biochemistry, or biological science with 5 + years of relevant industry experience and quality control experience
- Broad understanding of state-of-the-art physico-chemical analyses and ability to design comprehensive, biologics characterization strategy.
- Proficient to HPLC, CE and/or bioassay
- Hands-on experience with Empower 3
- Having extensive hands-on experience with multiple biophysical technologies for the characterization of higher order structure of biologics is an asset.
- Practical understanding of biologics purification process is an asset.
- Outstanding written and verbal communication skills, with the ability to convey strategies and results to a diverse audience.
- In-depth understanding of analytical development strategy to support regulatory filing.
- Being proactive and flexible