Location: Montreal, QC
The Technical Services scientist is responsible for inter-sites transfers (out/in) and transfers from the
development lab to the cGMP production area.
The Technical Services Scientist is also responsible of preparation and review of scientific documentation
for development studies such as protocols, manufacturing instructions, BOMs, master batch records and
summarize and draw conclusions (reports).
Key Tasks and Responsibilities:
• Support inter-sites (out/in) and internal transfers from R&D to commercial equipment.
• Manage the transfer of technical information with clients and perform a risk assessment to identify
any gaps.
• Write and review technical protocols and reports required for the manufacturing/ packaging of QbD
batches, scale up, registration batches and process validation.
• Provide technical support to Manufacturing Operations in problem solving and evaluating new
processes and equipment.
• Provide support for equipment selection and qualification.
• Assist in the development of validation protocols and the execution of validation activities.
• Maintain very good communication with the clients.
Qualifications:
• B.Eng. or B.Sc in a relevant scientific discipline such as chemistry or pharmaceutical science, with
a minimum of 3 years experience in Pharmaceutical industry is required.
• Very good knowledge and experience in pharmaceutical processes & equipment.
• Well versed in Quality by Design and Scale up of pharmaceutical products.
• Knowledge and understanding of cGMPs, validation requirements and techniques.
• Knowledge and experience in root-cause analysis, risk assessment and investigation tools and
techniques.
• Excellent organization, multi-tasking, and report writing skills.
• Strong English communication (verbal and written) and interpersonal skills.
• Proficient with Microsoft Office (Word, Excel, PowerPoint and Outlook), and MS Project.
• Ability to work independently and maintain confidential information.