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    Analytical Technical Steward

    Lilly
    0-2 years
    Not Disclosed
    Hyderabad India
    10 Feb. 11, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Analytical Technical Steward
    Location: Hyderabad, Telangana, India
    Category: Manufacturing/Quality
    Job Type: Full Time, Regular
    Job ID: R-79692

    Organization Overview:

    At Lilly, we are dedicated to discovering, developing, and delivering life-changing medicines that help people live longer, healthier lives. Beyond medications, we aim to support communities through philanthropy and volunteerism.

    Position Overview:

    The Analytical Technical Steward is a key technical role in API External Manufacturing Quality Control. The steward ensures the analytical testing of Active Pharmaceutical Ingredients (API) meets Lilly’s standards and external requirements. This position ensures data integrity, reviews deviations, analyzes trends, and supports continuous improvement initiatives. The role also involves collaboration with internal and external stakeholders to ensure robust analytical control strategies for supported molecules.

    Key Responsibilities:

    • Data Review and Interpretation:

      • Review and interpret data released from contract manufacturers (CM), stability testing, process validation, and reference standard characterization.
      • Lead in-depth investigations for out-of-specification (OOS) results, drawing conclusions and performing root cause analysis.

    • Investigational Testing:

      • Develop testing protocols for investigational purposes and perform testing as needed.

    • Technical Contributions:

      • Contribute to Annual Product Reviews (APR), tech transfer, and process validation efforts.

    • Audits and Communication:

      • Participate in internal and external audits.
      • Communicate effectively within the API EM organization and with external business partners.

    • Project Management:

      • Develop and execute quality plan projects and coordinate testing across multiple sites (e.g., batch release, stability, validation).

    • Method Assessments and Validation:

      • Assess analytical methods for deficiencies and areas of improvement.
      • Ensure method validation packages meet regulatory expectations and compendial monographs.

    • Method Transfer and Development:

      • Support method transfer and validation from Lilly to contract manufacturers.
      • Support method optimization, new method development, and troubleshooting in QC labs.

    • Reference Standards Management:

      • Oversee reference standard evaluations according to Global Quality Standards.
      • Support selection, characterization, and validation of reference standards.

    • Cross-functional Collaboration:

      • Work closely with development teams, contract manufacturers, and GQL to ensure effective execution of analytical strategies.

    Basic Requirements:

    • Education:

      • Bachelor’s degree in a science field such as Chemistry, Biochemistry, or Pharmacy (or equivalent experience).

    • Experience:

      • 5+ years of experience in the pharmaceutical industry, particularly in GMP labs (experience with large molecules, small molecules, and peptides is preferred).

    • Skills/Preferences:

      • Expertise in complex laboratory analysis, including chromatographic (HPLC, GC), spectroscopic, and LC-MS techniques.
      • Proficiency in root cause analysis and problem-solving.
      • Strong understanding of compliance requirements and regulatory expectations.
      • Demonstrated experience with method qualification, validation, and transfer.
      • Ability to work across networks and in cross-functional teams.

    • Technical Proficiency:

      • Proficient in establishing and maintaining GMP analytical equipment and supporting computer system validation (CSV).
      • Strong documentation and presentation skills, with the ability to communicate technical information effectively.

    Additional Information:

    • Physical Requirements:

      • Ability to lift up to 5 liters of liquid and stand for extended periods.
      • Occasional repetitive motions may be required.

    • Travel:

      • Up to approximately 20% travel, including international trips.

    • Role Location:

      • Based in Hyderabad, India.

    Equal Opportunity:

    Lilly is an Equal Opportunity/Affirmative Action Employer, committed to fostering an inclusive and diverse workforce. We do not discriminate on the basis of race, age, color, religion, gender, sexual orientation, gender identity, or any other legally protected status.

    #WeAreLilly

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