Centre for Probe Development and Commercialization
  • Hamilton, ON, CAN
  • Full Time

Company Profile:

The Centre for Probe Development and Commercialization (CPDC) is a leading provider of next-generation radiopharmaceuticals that are used globally on daily for the detection and treatment of human diseases such as cancer.

Radiopharmaceuticals are perishable products that require just-in-time manufacturing on a daily or weekly basis to ensure supply demands are met without interruption.  CPDC's success in the radiopharmaceutical industry results from the ability of our talented and committed staff to develop reproducible processes that yield high quality products while adhering to international regulations governing nuclear safety, transportation of dangerous goods and pharmaceutical manufacturing.

Qualities and Competencies:

  • Outstanding planning, collaboration and people management skills
  • Demonstrated hands-on technical leadership in finished product testing
  • Excellent interpersonal, organizational, and communication skills (verbal and written)
  • Strong problem-solving and troubleshooting skills
  • Ability to establish strong internal and external relationships
  • Must enjoy working in a fast-paced, high pressure, growth oriented environment

Responsibilities include, but are not limited to the following:

  • Lead daily operations to ensure timely and high-quality QC chemistry testing of products according to established protocols / SOPs
  • Recruit, manage training, supervise, and coordinate activities of staff to ensure production and testing schedule; conduct performance reviews
  • Lead OOS and OOT investigation
  • Develop and validate methods for QC
  • Develop and maintain SOPs, specifications, test methods, protocols, and reports to support QMS as per company policies, regulatory requirements, and customer specifications
  • Ensure test results and documentation are in accordance to GMP; ensure staff follow safety standards, policies & procedures, best practices, regulations, and SOPs
  • Manage and execute schedule for preventative maintenance, calibration, and validation within the lab
  • Collaborate with leadership team to develop QA action plans for batch release
  • Oversee data entry, trending, environmental monitoring activities, inventory management

Qualifications:

  • BSc. or higher in Chemistry or other relevant discipline with 5 years QC testing experience with at least 3 years at a supervisory level
  • Solid experience in analytical chemistry (HPLC, GC, TLC)
  • Experience managing teams:  planning/organizing laboratory activities, performance management/coaching, mentorship, motivating staff
  • Knowledge of applicable quality/regulatory frameworks with an emphasis on cGMP / ISO, Health Canada regulations
  • Experience with aseptic techniques / sterility assurance considered an asset
  • Position is days but also requires flexibility to work off shifts / come in off hours in support of a 24/7 manufacturing operation
  • Flexible to travel 10-15% within Ontario

If you require accommodation for your application or interview, please contact Human Resources directly at 905.525.9140 ext. 21112 or by email at careers@imagingprobes.ca

 

We thank all those who apply but only candidates selected for interviews will be contacted.

 

Centre for Probe Development and Commercialization
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