Senior Analytical Chemist

at  AtomVie Global Radiopharma Inc

AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases.
We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.

REQUIREMENTS

• Degree in Chemistry, Biological Chemistry or Biotechnology.
• M.Sc. or Ph.D is preferred.
• 8+ years’ hands-on experience in a pharmaceutical GMP environment.
• Hands-on experience with developing new analytical methods and validation.
• Flexibility in work schedule to support a 7-day work week and manufacturing/client demand at varying times (early morning/late evening).
• Ability to lift 23 kilograms required

ABOUT THE ROLE

Senior Analytical Chemist is an expert in quality control testing of pharmaceutical drug products and experienced in the areas of analytical test method development (HPLC, GC, etc.), method transfer, and validation. They provide technical leadership and project management support to the Analytical Development, Production and QA teams at AtomVie. The incumbent establishes work schedules and monitors assignments to ensure the successful completion of tasks in a timely fashion while ensuring consistent high quality in a constant effort to provide best support to the organization with professionalism and integrity.

WHAT YOU WILL DO

• Plan, implement and successfully complete assigned Analytical Development and Quality Control projects and tasks in a timely fashion while ensuring consistent high quality.
• Conduct analytical method development, transfer, and validation activities: Define comprehensive and complex validation procedures for all analytical methods based on scientific knowledge, experience and support from SMEs.
• Perform routine and complex validation activities independently per approved protocols, and provide guidance and oversight to junior staff working on these activities
• Provide analytical support for process development including characterization of starting materials, intermediates, API, and finished products.
• Perform structure elucidation of unknown impurities/degradation products.
• Write test reports, data summaries, and statistical evaluations/trending.
• Initiate change controls to implement/revise/improve programs and methods and monitor completion of all work in a timely fashion.
• Write (author), revise, and review technical documents, validation documents (protocols, reports), STMs, SOPs, specifications, change controls, etc. according to regulatory guidelines (ICH, USP, etc.) for review by management, QA and/or customers. Provide peer review and provide input for co-workers.
• Act as point of contact for other departments and team members for matters related to method development and validation
• Prepare presentations for client review to summarize results and project status updates and participate in client meetings.
• Perform troubleshooting and investigations in cross-functional teams in support of AD, QC, QA and other departments.
• 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 Purity, 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 and raw materials with contract laboratories or contract research organizations according to standard testing procedures, USP or EP.
• Assist QA in the management of third-party analytical testing service providers and vendor qualification.
• Conduct peer review of laboratory record and notebooks for AD/QC; create the release certificate of analysis.
• Conduct investigations for testing failure and non-conformances and implement corrective actions.
• Write technical documents (e.g. author/create specifications, test reports, data summaries, investigations, CAPAs); prepare CAPA implementation plans and take an active role in closing laboratory investigations.
• Responsible for training other colleagues, colleagues from other departments, and new staff in all department related disciplines.
• 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 and provide guidance and mentoring to others.
• Responsible for new equipment purchases and installation (quotes, URS, change control, SOPS, STMs, forms, IQ/OQ/PQ, etc.)
• 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 implement improvements.
• 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, and work with management to accommodate last minute changes or absences.
• Responsible for maintenance of documentation to fulfill applicable regulatory requirements relating to nuclear safety (e.g. radioactive material transfer forms).
• Adhere to GMP regulations by maintaining complete records pertaining to all aspects of training, analytical testing, routine operations, and equipment maintenance. Maintain an up-to-date training record.
• Understand and work under the Health Canada and FDA GMP requirements for sterile pharmaceuticals.
• Complete all other related duties, as required

WHAT YOU BRING TO THE ROLE

• Experience in QC testing of materials and products using HPLC, GC, TLC, etc.
• Proficiency in performing HPLC and GC method development and validation, including thorough documentation of such studies.
• Skilled in data interpretation of UV, IR, MS, and NMR spectra.
• Expertise in working with antibodies, proteins, and antibody-drug conjugates, including protein characterization, UV/VIS, etc., and proficiency in chemical analysis.
• Experience with sterile products, a background in working in a BSL2 laboratory, and knowledge of microbiological testing (Bioburden, Sterility, Bacterial Endotoxins) is considered an asset.
• Proficiency in using spreadsheets (e.g., Excel, Google Sheets) with the ability to rapidly input data and retrieve records, statistics, trends, etc.
• Strong writing skills, including the ability to compose technical documents, reports, and presentations for customer meetings.
• Excellent communication skills in English, coupled with the ability to work both independently and collaboratively in a team environment.