Antibody Reagent Process Scientist - Toronto, Ontario Canada - 20891

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JOB DESCRIPTION

Job #: 20891
Title: Antibody Reagent Process Scientist
Job Location: Toronto, Ontario - Canada
Employment Type:
Salary: contact recruiter for details
Employer Will Recruit From: Nationwide
Relocation Paid?: Negotiable

WHY IS THIS A GREAT OPPORTUNITY?


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.

JOB DESCRIPTION

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.

QUALIFICATIONS

REQUIREMENTS:

- 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

Education:
University - Bachelor's Degree/3-4 Year Degree