Quality Assurance, Batch Release

Fusion Pharmaceuticals; Hamilton; On-site; CAD 70,000 - 90,000; Full time

Job summary

A clinical-stage oncology company in Hamilton, Ontario is seeking a Quality Assurance professional for Batch Release. The individual will manage the final release of radiopharmaceutical batches ensuring compliance with regulatory and quality standards. Requires a Bachelor's degree in Chemistry or related field and a minimum of five years’ experience in quality assurance. This role involves extensive collaboration with Quality Control and Manufacturing teams. The position is onsite, with a commitment to quality and adherence to strict regulations.

Qualifications

• Minimum of five years of experience in compliance or quality assurance.
• QP Certification is a plus.
• Knowledge of cGMP, US FDA, and EU GMPs.

Responsibilities

• Perform the final approval of radiopharmaceutical batches.
• Review and approve batch production records.
• Evaluate and approve Certificate of Analysis for batches.

Education

Bachelor’s degree in Chemistry, Pharmaceuticals, or related science

Job description

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs.

Position Summary

Fusion has opened a newly created role in Quality Assurance for a Quality Assurance, Batch Release. The Quality Assurance, Batch Release role is responsible for managing and overseeing the final release of radiopharmaceutical batches for distribution. This role ensures that all radiopharmaceutical products meet regulatory requirements, quality specifications, and safety standards, and are ready for clinical or commercial use. The individual will work closely with Quality Control, Manufacturing, and Regulatory teams to ensure compliance with Good Manufacturing Practices (GMP) and relevant health authority regulations and guidance. This position is located onsite in Hamilton, Ontario, Canada.

Responsibilities

• Performs the final approval of radiopharmaceutical batches, ensuring compliance with regulatory and quality standards.

• Review and approve batch production records, ensuring they are complete, accurate, and meet all required specifications.

• Evaluate and approve Certificate of Analysis (COA) / Certificate of Compliance (COC) for each batch of radiopharmaceuticals, ensuring that they conform to the required quality control specifications.

• Ensure that each batch release is documented properly, including all associated records such as test results, quality control approvals, and any deviations or investigations.

• Monitor and enforce compliance with environmental, safety, and regulatory requirements related to the handling and release of radioactive materials.

• Collaborate with the Quality Control (QC) team or Contract Manufactures (CMO/CDMO) to ensure that all required testing and analysis (i.e., radiochemical purity, stability, endotoxin levels, etc.) are completed prior to batch release.

• Facilitate the resolution of any issues related to non-conformance, deviations, or out-of-specification (OOS) results that may arise during the batch release process.

• Participate in the investigation and root cause analysis of any batch failures or deviations from expected results.

• Provide guidance and support during internal or external audits related to batch release processes.

• Prepare and deliver periodic reports on batch release activities, trends, and any issues encountered.

• Perform other duties and responsibilities as assigned.

Qualifications

•Bachelor’s degree in Chemistry, Pharmaceuticals, or other related science from an accredited institution plus a minimum of five (5) years of experience in compliance, quality assurance, quality orientation, or manufacturing document review.

• QP Certification is a plus and working knowledge and experience with cGMP, US FDA and basic knowledge of EU GMPs.

• Demonstrated proficiency in oral and written interpersonal communication skills.

• Demonstrated investigative techniques to uncover problem areas and recommend corrective actions. Problem solving ability requiring attention to detail, accuracy, cGMP and scientific judgment.

• Frequent use and general knowledge of domestic and foreign industry practices, techniques, and standards. General applications of concepts and principles.

• Understands and applies knowledge of manufacturing/packaging principles.

• Develops solutions to a variety of problems of moderate scope and complexity.

• Refers to local and corporate policies and procedures for guidance.

• Demonstrated commitment to quality in all work.

• Weekend work and up to 20% travel is possible.

Fusion Pharmaceuticals is an equal opportunity employer that is committed to inclusive, barrier-free recruitment and selection processes, if contacted for an interview, please advise Human Resources if you require accommodation.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual, gender identity, national origin, disability, or status as a protected veteran.