Senior Scientist, Analytical Chemist

Eli Lilly

  • Toronto, ON
  • Permanent
  • Full-time
  • 30 days ago
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.About POINT Biopharma:POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. Recently acquired by Eli Lilly and Company, POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT is a wholly owned subsidiary of Eli Lilly and Company.Position Summary:Reporting to the Senior Principal Scientist, Process Chemist, the Analytical Chemist is knowledgeable in applicable regulatory guidance and in the development of analytical methods for the testing of radiopharmaceuticals. The Analytical Chemist will provide support in authoring and reviewing technical documents (e.g., standard test methods, change controls, protocols, and reports), and the quality sections (i.e., Modules 2 and 3) of Common Technical Document (CTD) for regulatory submissions, amendments and information requests. The Analytical Chemist will also assist in technical review and compiling analytical data to support process development. The Analytical Chemist will work in collaboration with POINT CMC team members, other POINT departments, and external partners (CMOs) to develop and validate analytical methods to demonstrate the quality attributes of novel radioligands to enable POINT’s late phase programs.Roles and Responsibilities of the Position:
  • 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.
Required Qualifications:
  • 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).
Additional Preferences:
  • 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.
Physical Demands/Travel:
  • 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.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.Work Environment:
  • Position works remotely.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Eli Lilly Canada is committed to employment equity. We encourage applications from qualified women, members of visible minorities, aboriginal peoples, and persons with disabilities.Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources (Lilly_Recruiting_Compliance@lists.lilly.com) for further assistance. Please note this email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.#WeAreLilly

Eli Lilly