Scientist - Chemistry, Manufacturing and Controls (CMC)

ISOLOGIC Innovative Radiopharmaceuticals offers you an exceptional opportunity to join our dynamic team as a Scientist - Chemistry, Manufacturing and Controls (CMC)! CMC involves defining manufacturing practices and product specifications that must be followed and met in order to ensure product safety and consistency between batches. If you have a passion for nuclear medicine and want to make a significant contribution to patient care while working in a stimulating and dynamic environment, then this opportunity is for you.

ISOLOGIC is a national company dedicated to nuclear medicine and radiopharmaceutical production. Our mission is to assist physicians by providing the most relevant radiopharmaceutical products for PET and SPECT in a safe and reliable manner, thereby contributing to saving lives.

Your role with us: As a Scientist in the CMC department, your primary responsibility will be to support manufacturing and quality control activities for Investigational Medicinal Products. This involves various tasks, including manufacturing products in compliance with GMP, dispensing and packaging these products, ensuring the cleanliness and disinfection of designated areas, and managing inventory.

40 hours per week from Monday to Friday. May require weekend and night work depending on business needs. May be required to travel with overnight stay at other ISOLOGIC sites.

Main responsibilities

• Aids in manufacturing, quality control, and related activities for the sterile radiolabeling of products within the CMC group at the Toronto facility, ensuring compliance with Isologic policies and procedures.
• Assists in materials and inventory management for CMC products, including the receipt and release of incoming materials.
• Operates computers and software, including cyclotron and synthesis module operation.
• Cleaning and disinfecting controlled rooms and areas.
• Performs environmental sampling during manufacturing.
• Participates in the manufacturing and quality control of CMC products at the Toronto facility, and when necessary, at other Isologic facilities (Montreal). Provides troubleshooting support for manufacturing and QC issues and collaborates on all investigations and deviations.
• Under Chemist supervision, conduct research to develop and optimize analytical methods for new CMC products. Validate methods when needed. Also, support Tech Transfer projects for new compound introduction at Isologic.
• Develops production and quality control procedures in collaboration with other departments.
• Prepares scientific documentation, validation, and reports. Verifies and approves results when needed.
• Handles and packages radiopharmaceuticals and hazardous materials in compliance with company policies and procedures, corporate standards and federal/provincial regulations.
• Works closely with Operations team to ensure employees are working in compliance with internal policies and procedures and addresses any deficiencies.
• Establishes and maintains effective communication with the management team and all employees to ensure an efficient and problem-free work environment.
• Assist in the repairs and maintenance of equipment, as per qualifications.

Skills / Qualifications

• Bachelor’s degree in a scientific discipline from a Canadian university or equivalent required.
• Previous experience in a GMP environment within Manufacturing and/or Quality Control units is an asset.
• Demonstrate detailed knowledge in biochemistry, chemistry, and radiochemistry.
• Background or practical experience in Nuclear Medicine Technology or Radiopharmaceutical sciences is desirable.
• Must be comfortable working with radioactive materials.
• Ability to accommodate shift changes based on business needs.
• Experience with HPLC and GC is an asset.
• Involves working in a normal laboratory and cleanroom environment for production, which includes handling radioactive substances and common chemicals.
• Must be able to lift 50 lbs. from the ground to waist level and possess the dexterity to handle lead pigs and bricks.

Join the ISOLOGIC team and enjoy a pleasant, productive and stimulating working environment, where your ideas and know-how will be encouraged. Take part in challenges that match your talent, and contribute to our mission of saving lives through innovative nuclear medicine solutions. In a dynamic and adaptable environment, focused on continuous improvement, your new ideas and expertise will be fully appreciated.

Job Types: Full-time, Permanent

Salary: $60,000.00-$70,000.00 per year

Benefits:

• Dental care
• Disability insurance
• Employee assistance program
• Extended health care
• On-site parking
• RRSP match
• Vision care

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person