Scientist, Product Development
$77,285–$101,199 year
On-siteRichmond Hill, Ontario, Canada
Job Summary
Conduct formulation development experiments using Quality by Design principles to optimize stable liquid dosage forms for commercial production. Lead the design and execution of Design of Experiments for composition optimization and critical material attribute identification. Prepare Reference Listed Drug characterization reports, define Quality Target Product Profiles, and manage technical documentation for IND/NDA/ANDA submissions. Collaborate cross-functionally with Analytical Development and Regulatory Affairs teams to support technology transfer, scale-up activities, and regulatory queries. Investigate complex formulation challenges and resolve issues using statistical analysis and unconventional techniques.
Required Qualifications
- Bachelor's degree
- Minimum 5 – 8 years of experience
- Experience in a pharmaceutical development environment
- Excellent working and theoretical knowledge of liquid dosage formulations
- Knowledge of sterile and non-sterile manufacturing
- Knowledge of combination product requirements
- 5+ years of hands-on experience in respiratory and/or nasal drug delivery
- 3+ years of hands-on experience in sterile/Injectable pharmaceutical formulation development
- Proven track record of successful formulation development and commercialization
- Experience with statistical design of experiments (DOE) and data analysis
- Excellent organization and report writing skills
- Advance level of computer skills in Microsoft Office (Word, Excel, PowerPoint and Outlook)
- Good knowledge of cGMP and regulatory requirements
Desired Qualifications
- Master's degree
- PhD in Pharmacy, Pharmaceutical Technology, science or engineering
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