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Analytical Chemist
1 week ago
We are seeking an experienced Bioanalyst to join our team at AtomVie Global Radiopharma Inc. As a leader in the manufacturing and distribution of clinical and commercial radiopharmaceuticals, we are committed to advancing high-quality drugs for the treatment and diagnosis of diseases.
About the RoleThe AD Biochemist I will be responsible for developing and implementing analytical methods for biological and microbiological testing, while ensuring compliance with company policies and GMP regulations. This role requires strong technical expertise and the ability to work effectively in a team environment.
Main Responsibilities- Develop and validate analytical methods for biological and microbiological testing, including biological assays, microbial identification, and endotoxin testing.
- Conduct quality control testing of finished drug products using approved methods and write validation reports according to regulatory guidelines.
- SUPPORT RAW MATERIAL RELEASE: Coordinate quality testing of excipients, precursors, and drug substances for internal testing or external testing via contract laboratories or research organizations.
- PERFORM QUALITY INVESTIGATIONS: Investigate non-conformances and testing failures, prepare CAPA implementation plans, and implement corrective actions.
- PARTICIPATE IN PROCESS IMPROVEMENT INITIATIVES: Participate in process improvement initiatives, including initiating change controls, revising methods, and creating new procedures.
- MANAGE LABORATORY INVENTORY: Manage inventory of analytical reagents, critical materials, reference standards, and consumables.
- MULTIPLE RESPONSIBILITIES: Perform multiple responsibilities as assigned by management, including handling hazardous waste disposal (chemical and radioactive).
- University degree in biology, biological chemistry, biotechnology, or a related field.
- 3-4 years of experience in a pharmaceutical cGMP environment, performing analytical chemistry techniques such as HPLC, GC, TLC, and biological assays.
- Knowledge of regulatory guidelines, pharmacopeias, ICH, and business protocols and procedures.
- Experience working with sterile products and in a BSL2 laboratory.
- Ability to work effectively in a team environment and communicate complex scientific information to colleagues and management.
