|Title:||Antibody Reagent Process Scientist|
|Job Location:||Toronto, Ontario - Canada|
|Salary:||contact recruiter for details|
|Employer Will Recruit From:||Nationwide|
Description: Toronto arm of leading international medical device organization is looking for a Reagent Process Scientist to oversee the processes involved in the transdr of early to late stage manufacturing of antibody / biomarker / genomics R&D reagents. These compounds are used in both basic and clinical research and biopharma applications world wide.
ROLE AND RESPONSIBILITIES:
- Design transfer of robust processes from small scale into large scale manufacturing.
- Technical support, design verification, and validation test plans, plus protocols for new or modified products.
- Link between Operations and R&D.
- Documentation, regulatory compliance, risk management, quality and root cause investigations.
- New product and process planning going forward, based on a strong understanding of existing products and processes.
- BS Biochemistry/Chemistry/related and 5 to 10 years' industry background.
- Prefer some synthetic chemistry knowledge. - Background working in manufacturing, product transfer or product support functions.
- Working knowledge of ISO 13485 and Design Control elements. specifically.
- Equipment qualification protocols (IQ, OQ, and PQ), process validations, software validations,and other validation lifecycle documents.
- Manufacturing documents including SOPs, specification and work sheets.
- Manufacturing-related drawings, machine specifications, and required test equipment/fixtures.
- Strong problem solving, multitasking, MS Office computer, and communication skills.
- Great at interpreting common scientific, technical, government reports and publications
University - Bachelor's Degree/3-4 Year Degree