Senior Scientist, Analytical Chemist
Eli Lilly
- Toronto, ON
- Permanent
- Full-time
- Review experimental data both internally and from external vendors / partners.
- Summarize and interpret results, relaying findings through summary reports, technical documents, or presentations.
- Provide technical support in the preparation and interactions with regulatory agencies regarding drug submissions and information requests.
- Draft, edit, and review the analytical sections of CTD for regulatory submissions, amendments, and prepare responses to information requests from regulators.
- Contribute to the development of analytical methods for the testing of POINT drug products, including chromatography methods (i.e. HPLC, TLC and GC) and spectroscopy methods (i.e. gamma spectroscopy, mass spectrometry) according to phase appropriate guidelines (e.g. cGLP, cGMP).
- Prepare method validation and stability protocols and reports in accordance with applicable compendial guidelines (e.g. USP, EP and ICH).
- Provide technical expertise as required for the development, troubleshooting and tech transferring of analytical methods to external vendors / partners.
- Ensure analytical methods are designed and validated per phase appropriate requirements while meeting project timelines.
- Adhere to all applicable procedures, cGLP, cGMPs, company policies and other quality or regulatory requirements.
- Prepare and deliver presentations for internal and external team meetings.
- Author technical, quality and regulatory documents to support regulatory submissions.
- Maintain good relationships with partners, CMOs, vendors and suppliers.
- Embody and promote a quality culture and “right-the-first-time” approach to all activities.
- Work well in a fast-paced environment.
- Perform other duties as assigned.
- BS/BA or MSc degree in chemistry or a related discipline.
- 5 years of relevant industry experience in analytical development, validation, and testing in a GMP setting.
- Proficient in modern analytical chemistry including developing, validating, and executing methods using TLC, HPLC/UPLC, NMR and mass spectrometry.
- Proven ability to work independently with strong organization and communication skills.
- Demonstrated ability to successfully prioritize projects and manage timelines in a fast-paced environment.
- Functional knowledge of GMPs and applicable FDA, EMA, Health Canada, USP, ICH and PDA guidelines.
- Proficient in MS 365 (Excel, Word, PowerPoint).
- Experienced in quality control testing of radiopharmaceuticals is considered an asset.
- Hands-on experience with radiopharmaceutical testing including Radiometric TLC and HPLC-UV with radiometric detection of PET radioisotopes (F-18, Ga-68, Cu-67) and/or therapeutic radioisotopes (Lu-177, Ac-225) is considered an asset.
- Knowledge of environmental health and radioprotection requirements are considered assets.
- Position will require up to 20% travel within North America and abroad into the EU. A valid passport and eligible to travel into these countries are required.
- Position works remotely.