Responsibilities
- Translate established radiolabelling methods to automated systems for the production of radiopharmaceuticals according to GMP
- Develops and/or oversee precursor manufacturing, including scale-up, according to GMP
- Work closely with analytical colleagues, design and execute experiments to make improvements and optimize yields and purity
- Lead tech transfer activities within the Centre, between sites and with clients (travel required)
- Provide technical support within the Centre and across sites, including leading investigations and performing root cause analysis of process failures
- Source raw materials, process components and container closures for kits and finished products
- Write master batch records, Standard Operating Procedures (SOPs), specifications, protocols and reports
- Collaborate with co-workers to solve problems encountered in process development and with routine manufacturing, including having the ability to communicate and interact effectively with colleagues in other departments
- Provide support for submissions to Health Canada, probe production and distribution programs
- Timely preparation of GMP documentation as required. This includes (but is not limited to) Change Control Requests, Master Batch Records, batch instructions, deviation reports, validation documentation, annual product reviews, standard operating procedures, regulatory response documentation.
- Perform daily production of radiopharmaceuticals including dispensing and shipping of doses when required
- Under the direction of the cyclotron engineer, and when required, operate cyclotron
- Work according to the Health Canada GMP requirements and the Annexes to the GMP for Positron Emitting Radiopharmaceuticals (PERs) and Schedule C Drugs
- Work according to the Canadian Nuclear Safety Commission regulations
- Complete all other related duties that support the core activities and mission of the Centre
Qualifications
- PhD in Chemistry or Chemical Engineering with 1 – 2 years of relevant experience (recent PhD graduates will be considered for a Post-doctoral role)
- MSc in Chemistry or Chemical Engineering with 2 – 5 years of relevant experience
- BSc in Chemistry or Chemical Engineering with 5 or more years of relevant experience
- Experience in synthetic chemistry and/or radiochemistry is preferred.
- Experience with automated synthesizer units for radiochemistry and GMP experience is considered an asset
To apply please submit a cover letter and resume to: careers@imagingprobes.ca
Attention: Dr. Joe McCann Director, Radiopharmaceutical Development and Manufacturing
Centre for Probe Development and Commercialization (CPDC)
1280 Main Street West, NRB‐101, Hamilton, ON L8S 4K1
We thank all applicants for their interest, but only those selected for interview will be contacted