Centre For Probe Development And Commercialization Hiring for Quality Control Supervsior at Toronto, ON Full Time

The Centre for Probe Development and Commercialization (CPDC) is a leading provider, on a global basis, of next-generation radiopharmaceuticals that are used 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 and manufacture high quality products, while adhering to international regulations governing nuclear safety, transportation of dangerous goods and pharmaceutical manufacturing.
About the role:
The Supervisor of Quality Control and Analytical Development oversees the transfer, development, validation, and routine application of methods for physical and chemical characterization of small and large molecule drug substances and drug products, and ensures that methods are suitable for routine quality control and in compliance with Good Manufacturing Practices (GMP) for both investigational and commercial products.
Location: Toronto
Duties/Responsibilities include:

• Provide leadership, technical guidance, supervision and hands-on support to ensure successful translation of diagnostic and therapeutic radiopharmaceuticals along the development pathway to commercial launch.
• Day-to-day coordination and schedule of activities of assigned analysts/technicians to ensure all required daily testing is completed for pre-clinical, clinical, and commercial materials.
• Work with clients and internal departments to create and manage detailed project plans such that client timeline and budgetary expectations are met.
• Oversee client projects and client communications, prepare presentations, attend client meetings and provide client technical support as needed.
• Monitor progress and ensure timely completion of investigations, non-conformances, CAPAs, and change controls.

• Ensure that team is able to plan, implement and complete assigned tasks in a timely fashion ensuring consistent high quality in accordance with GMP and CPDC SOPs
• Carry out analytical method development, transfer, troubleshooting, and validation.
• Perform quality control testing of incoming materials, drug substances, and drug products according to standard operating procedures
• Ensure that routine quality operations including installation/calibration/maintenance of equipment, reagent inventory, and facility housekeeping are properly maintained.
• Conduct peer review of laboratory records and ensure adherence of assigned staff to GMP regulations by reviewing records pertaining to all aspects of analytical and microbiological testing, routine operations, and equipment maintenance.
• Conduct investigations for testing failure and non-conformances, and implement corrective actions.
• Write, revise, create and review technical documents, including INVs, NCs, CAPAs, validation documents (protocols, reports), STMs, SOPs, specifications, change controls, etc. according to regulatory guidelines (ICH, USP, etc.) with input from SMEs, for review by management, QA and/or customers. Write test reports, data summaries, and statistical evaluations/trending.
• Maintain a working understanding of appropriate regulatory guidance, international pharmacopeias, ICH, established business processes and protocols, and applicable standard operating procedures.
• Responsible for understanding and working under the Health Canada GMP requirements for sterile pharmaceuticals and the Annex to the GMPs for Positron Emitting Radiopharmaceuticals (PERs).
• Manage training plans for assigned staff and ensure sufficient cross-training is in place to allow for completion of daily tasks. Identify and assist in conducting cross functional training to maintain and improve the growth of employee knowledge and the flexibility of staff to support process development and production.
• Conduct performance reviews and establish performance expectations and performance improvement plans.
• Continually work on broadening technical expertise of self and the team to support current products and develop future drugs within the company portfolio or through support of our CDMO functions.
• Maintain current industry knowledge in analytical quality topics, regulations, and publications.
• Accomplish human resource objectives by training, assigning, scheduling, coaching, communicating job expectations, monitoring performance, conducting performance reviews, supporting career development activities; and enforcing policies and procedures.
• Conducts self and all activities with the highest level of competency and reliability, follows company policies and procedures and shows support for the organization’s goals and values.
• Shows understanding for unique challenges of radiopharmaceutical industry with respect to shifts, hours, and overtime.
• Works collaboratively with team members to ensure that tasks are covered in the event of unexpected absences.
• Maintain an accurate training record.
• Adhere to the GMP regulations for sterile pharmaceuticals, microbiological testing, and quality control testing.
• Maintain a working understanding of appropriate regulatory guidance, international pharmacopeias, ICH, established business processes and protocols, and applicable standard operating procedures.
• Responsible for understanding and working under the Health Canada GMP requirements for sterile pharmaceuticals and the Annex to the GMPs for Positron Emitting Radiopharmaceuticals (PERs)
• Ensures compliance with Health, Safety and Environment protection rules, with engagement of all associates to apply the policies, procedures and regulations applicable to their work.
• Understand and work under the Canadian Nuclear Safety Commission regulations.

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Qualifications/Education: *

• M.Sc. or Ph.D in Chemistry , Biological Chemistry, Biotechnology, or a related discipline
• 5 – 10 years, direct hands-on laboratory experience in pharma/biotech manufacturing organizations, performing method development, validation and quality control tasks.
• Experience in analytical techniques for chemical testing (e.g. HPLC, GC, TLC, wet chemistry, etc.) and microbiological testing (Bacterial Endotoxins, sterility, etc.), as well as material characterization (NMR, MS, IR, MALDI, etc.)
• Knowledgeable in use of Chromatographic Data Software for relevant equipment, use of spreadsheets (Excel), databases, and word processing software.

• 2-5 years, experience in leading, managing and coaching work teams in a GMP environment.
• Flexibility in work schedule to support a night-day shift production environment with ability to adjust work schedule based on business requirements.
• Strong project management skills and excellent organizational skills with the ability to work independently and within a team.
• Excellent communication skills (written and verbal) and technical writing skills. Ability to present scientific data to clients with professionalism.
• Demonstrated ability to successfully prioritize, manage time well, multitask and troubleshoot problems.
• Proven ability to assess and make risk-based decisions while keeping stakeholders apprised
• Experienced in assessing a situation, identifying issues and developing solutions that result in efficiencies or process improvements. Ability to adapt to change and to overcome obstacles.
• Ability to lift 23 kilograms required

CPDC offers:

• Competitive compensation
• Medical and dental benefits, sick days & more
• Opportunity for long-term growth
• Professional & collaborative environment with experienced individuals in the field
• Join a passionate team making a difference in patients’ lives and Canadian

If you require accommodation for your application or interview, please contact Human Resources directly at 905.525.9140 ext. 21112 or by email at [email protected]
We thank all those who apply but only candidates selected for interviews will be contacted.

Job Type: Full-time