Analytical Chemist

The Centre for Probe Development and Commercialization **(CPDC) **is a global leader of next-generation radiopharmaceuticals. At CPDC we are working with our partners to discover, develop and distribute the next generation of imaging agents and targeted radiotherapeutics for the detection and treatment of human diseases such as cancer. Our Centre has the full range of scientific, technical, regulatory and business expertise combined with specialized infrastructure required to translate radiopharmaceuticals from clinics to the commercial marketplace.

Radiopharmaceuticals are perishable products that require just-in-time manufacturing. CPDC's success in the radiopharmaceutical industry results in the ability of our talented staff to develop reproducible processes that yield high quality products while adhering to international regulations governing nuclear safety, transportation of goods, and pharmaceutical manufacturing. Our staff take pride in the impact we make everyday in the lives of patients across the globe.
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About The Role: *
The **Analytical Chemist** is responsible for working in accordance with company policy and within GMPs, while contributing technical expertise to support current products and develop future drugs within the CPDC portfolio or through support of our CMO functions. CPDC is looking forward to welcoming two Analytical Chemists; at the senior and intermediate level of experience.

**Responsibilities**:

- Perform quality control (release & retrospective) testing of incoming materials, drug substances, and finished drug products according to standard testing methods (STMs), including Chemical (e.g. HPLC Assay and Impurities, Radiochemical Puritiy, pH, iTLC, Residual solvents by GC), Biological (e.g. ELISA, IRF, Protein content), and Microbiological (e.g. Bacterial Endotoxin) testing methods. Methods may be compendial (USP, EP) or in-house methods.
- Coordinate quality control (release &retrospective) testing of drug substances with contract laboratories or contract research organizations according standard testing procedures, USP or EP.
- Conduct analytical method development, transfer, and validation activities: Write routine validation protocols with input from SMEs. Perform routine validation activities independently and more complex validations with guidance, as per approved protocols. Write validation reports according to regulatory guidelines (ICH, USP, etc.) with input from SMEs.
- Conduct all work in accordance with CPDC Standard Operating Procedures (SOPs) and raise any deviations immediately to the attention of Lab Management and Quality Assurance.
- Conduct peer review of laboratory records; create the release certificate of analysis.
- Write technical documents (e.g. author/create specifications, test reports, data summaries, investigations, CAPAs); prepare CAPA implementation plans and participate in closing laboratory investigations.
- Write (author) new STMs, SOPs controlled forms, data entry templates, etc., provide peer review and provide input for co-workers. Initiate change controls (prepare change control proposal) and revise/improve existing methods.
- Responsible for training other colleagues, colleagues from other departments, and new staff.
- Perform routine quality operations including calibration/maintenance of equipment and inventory/material management of incoming raw materials/container closures and analytical reagents, when required. Troubleshoot systems with guidance from SME.
- Responsible for the housekeeping of the facility including the disposal of hazardous waste (chemical and radioactive) through the appropriate waste-streams. Monitor effectiveness of the housekeeping and waste procedures and propose improvements to management.
- Work as a member of a team to achieve all outcomes; ensure that daily work activities are aligned with a production and stability plan/calendar.
- Responsible for maintenance of documentation to fulfill applicable regulatory requirements relating to nuclear safety (e.g. radioactive material transfer forms).
- Any other duties as assigned.
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Experience and Skills Required: *
- Degree in Biology, Biological Chemistry, Biotechnology, or a related discipline.
- M.Sc. or Ph.D is preferred.
- 5-7 years’ hands-on experience in a pharmaceutical GMP environment,
- Performing QC testing of materials and products using HPLC, GC, TLC, etc.
- Working with antibodies, proteins and antibody-drug conjugates, protein characterization, UV/VIS, etc.) and chemical analysis
- Experience in method development and validation, and documentation of such studies, is an asset.
- Experience working with sterile products, working in a BSL2 laboratory, and knowledge of microbiological testing (Bioburden, Sterility, Bacterial Endotoxins) is an asset.
- Knowledge of UV, IR, mass spectrometry, and NMR is an asset.
- Proficiency with spreadsheets (e.g. Excel, Google Sheets); with the ability to rapidly input data and retrieve records, statistics, trends