Job Title:
Analytical Technical Steward – Peptides
Location:
Hyderabad, Telangana, India
Job ID: R-84060
Category: Manufacturing/Quality
Job Type: Full Time | Regular
Purpose:
The Analytical Technical Steward plays a key role in ensuring analytical integrity and regulatory compliance for peptide-based APIs manufactured at contract manufacturing sites. This role requires in-depth analytical expertise, data integrity oversight, deviation investigations, and support for method validation, improvement, and transfers — primarily in the peptide space. The role includes routine in-person visits (up to 4 times per week) to CM sites (primarily in Visakhapatnam).
Key Responsibilities:
Technical Stewardship & Oversight
Review and release analytical data (including stability and validation results).
Ensure data meets internal quality and regulatory expectations.
Conduct method assessments, validations, and gap remediations.
Issue Resolution & Investigations
Lead root cause analysis (RCA) and investigate aberrant data or test failures.
Perform investigational testing when required.
Regulatory & Lifecycle Support
Support method sections of NDA/BLA submissions.
Ensure compendial alignment and regulatory compliance of analytical methods.
Review and approve test methods and characterization protocols.
QC Laboratory Support
Transfer, improve, or validate analytical methods across Lilly and contract labs.
Maintain oversight of reference standards and their analytical evaluation.
Ensure lab data integrity at contract sites and enforce remediation where needed.
Cross-functional Integration
Collaborate with global quality teams, development, and external manufacturers.
Participate in audits, tech transfers, APRs, and quality planning.
Requirements:
Education:
Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmacy (Master’s preferred)
Experience:
10+ years in GMP pharmaceutical laboratories
Must have experience in:
Peptide synthesis (SPPS/LPPS) or large molecule APIs
NDA submissions (BLA preferred)
Characterization and comparability assessments
Working with contract labs/manufacturers
Technical Proficiency:
Expertise in HPLC (RP, SEC), GC, MS, KF, particle sizing, LOD, bioassay, and compendial methods
Validation, transfer, and regulatory submission writing
Computer System Validation (CSV) understanding
Soft Skills & Other:
Strong documentation and communication skills
Problem-solving and RCA training preferred
Willingness to travel between Hyderabad and Visakhapatnam and internationally if needed
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