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Senior Scientist/Lead Scientist

1 month ago

Bengaluru, Karnataka, India Lilly Full time
Job Title: Principal Scientist/ Senior Principal Scientist

We are seeking a highly skilled and experienced Principal Scientist/Senior Principal Scientist to join our team at Lilly. As a key member of our Medicines Innovation Hub, you will play a critical role in the development and delivery of creative medicines to patients around the world.

Job Summary:

The successful candidate will support extractable and leachable studies for pharmaceutical development and manufacturing through working closely with external testing laboratories and Lilly internal functional areas. This includes attending cross-functional meetings, documenting proposal requests, reviewing quotes, and interfacing with procurement to request purchase orders.

Key Responsibilities:
  1. Attend cross-functional meetings with project leads to understand timelines necessary for E&L studies.
  2. Work with Development and Manufacturing to ensure requesting DS and DP samples and control samples from relevant studies.
  3. Document proposal requests and review quotes for studies with external suppliers.
  4. Interface with Procurement to request Purchase Orders.
  5. Review extractables study lab protocols to support the Lilly platform.
  6. Review leachables study lab protocols to support molecule-specific DS and DP.
  7. Review molecule-specific methods developed for the leachables studies for qualification/validation criteria.
  8. Review the strategy documents for the molecule-specific leachables study for the DS and DP Container Closure Systems.
  9. Work with Global Packaging engineers in DDCS to obtain samples and information needed for studies.
  10. Coordinate shipping of samples to external suppliers for E&L studies.
  11. Organize and help review extractables and leachables study reports provided by external study suppliers prior to completion and then once approved upload to Lilly QDocs.
  12. Provide data integrity review of extractable and leachables study result summaries/reports to share with Lilly toxicologists for assessments.
  13. Perform data integrity review of the regulatory submission sections relevant to E&L assessments.
Requirements:
  1. BS or MS in Analytical Chemistry, Organic Chemistry, or related field.
  2. Knowledge or hands-on experience in Analytical Chemistry, especially those in sample preparation and analysis of organic compounds and related species using various analytical techniques, e.g. GC-MS, GC-FID, LC-PAD-MS, ICP-MS, HPLC-CAD/ELSD, ion-chromatography, TOC, NMR, etc.
  3. 7-10 years of relevant experience in Extractable Leachables assessment or other relevant analytical development areas.
  4. Experience in identification of organic compounds and degradants using advance mass spectrometry techniques (e.g., high-resolution tandem mass spectrometry).
  5. Knowledge of relevant regulatory guidance (e.g., USP, ICH) on analytical methods and extractable and leachable studies.
  6. Familiarity with Microsoft Office Tools. Skills in Power BI or computer programming languages and database tools is desirable.
  7. Excellent written and oral communication skills.
  8. Excellent critical thinking capability and attention to details.
  9. Highly organized and efficient in executing complex tasks under tight timeline.
  10. Highly motivated to learn new knowledge and skills.
  11. Ability to collaborate effectively with others in a fast-paced multifunctional team environment.
Additional Information:

Lilly is an equal opportunity employer and 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.