Process Development Specialist

Location: Kanata, Ontario

Vacancies: 1

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.

Responsibilities:

• 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.