Process Development Specialist
Location: Kanata, Ontario
Duration: 1 Year
We are recruiting for a Process Development Specialist (12 mth term) with the focus of leading a GMP Technology Transfer for our Kanata, Ontario Facility.
- Technical Lead for Technology Transfer (TT) (coordinate and track review of information)
- Organize technical assessments, identify gaps, and escalate issues and risks to the Technology Transfer Project Manager
- Communicate TT gaps with the Development and Validation team to ensure that these are appropriately addressed
- Prepare pre-gating and gating meeting information
- Prepare and maintain overall training plan for the project
- Lead process and product risk assessments.
- Identify continuous improvements
- Provides technical assistance, including assessment of the impact of changes to the validated state of products and prepares technical justifications in support of quality disposition.
Experience, Knowledge, and Skills Required:
- Minimum B.Sc degree in Life Sciences, or comparable program.
- Industry experience in a cGMP Pharmaceutical Development, Manufacturing, and Testing environment
- At least 7 years of relevant technical experience.
- Strong technical writing skills
- Strong organizational skills
- Knowledge of cGMPs
- Demonstrated experience completing cGMP Technology Transfer for a pharmaceutical or medical device product.
- Experience with completing process risk assessments
- Experience with analytical methods.
- Motivation to work effectively and cooperatively with others, and to establish and maintain good working relationships
- Nuclear Energy Worker.