Analytical Technical Steward-Peptides

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Job Description - Analytical Technical Steward-Peptide (Hyderabad, India)

Organization Overview

At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better.

The Analytical Technical Steward in API (Active Pharmaceutical Ingredient) External Manufacturing Quality Control is a technical position helping to ensure that the analytical testing of products at multiple sites meets both Lilly and external requirements and is executed consistently to predetermined standards. This position will be Peptide focused and will require in-person site visits to the contract manufacturer up to four times per week or as needed. The Analytical Technical Steward reviews data released by contract manufacturers according to API EM Risk Based Oversight Governance to ensure it meets internal integration and data integrity expectations, reviews deviations for trends, reviews and/or releases stability data, and leads resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results. They may perform non-routine lab work in support of this. Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional internal and joint process teams. The Analytical Technical Steward works closely with development counterparts and GQL (Global Quality Laboratories) to ensure robust analytical control strategies are established for molecules they support.  

Responsibilities:

• Technical review, interpretation, and release of data including data released from CM (Contract Manufacturers), stability, process validation, and reference standard characterization.
• Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence.
• Develop investigational testing protocols and perform testing as required.
• Contribute to APR, tech transfer, and process validation as required.
• Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners.
• Participate in internal/external audits as needed.
• Develop and ensure execution of quality plan projects.
• Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing.
• Performs method assessments, with deficiencies and areas for improvement noted within the assessments.
• Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed.
• Participates in method validations according to Global Quality Standards (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in practices).
• Review of analytical test method packages.
• Approval of test method protocols.
• Approval of new test methods or changes or deletions to existing test methods.
• Provides laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including: laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions).
• Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies.
• Improve assays in QC. These improvements include variability reduction, method optimization, and new method development.
• Local and Global Method Change Control Ownership.
• Oversight of reference standard evaluations per Global Quality Standards.
• Selection of appropriate packaging materials.
• Consult in the preparation of the characterization protocol for corporate reference standards.
• Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards.
• Participate in the review of the reference standard profile and associated documentation for data integrity and technical assessment
• Oversee transfer and validations of analytical methods for marketed products to CM laboratories or to designated third party QC labs.
• Monograph review and implementation.
• Ensures consistent practices between laboratories running the same methods.
• Effective management of multiple projects.
• Oversight of laboratory data integrity compliance at contract manufacturers, and uses effective influence to ensure appropriate compliance.

Basic Requirements:

• Bachelor degree in a science field related to the lab (e.g. Chemistry, Biochemistry, Biology, Pharmacy), Masters degree preferred
• 10+ years of industry related experience in pharmaceuticals in a GMP lab
• Location of position: Hyderabad, India with routine travel to Visakhapatnam required
• Must have experience in GMP laboratory and experience with contract laboratories and/or contract manufacturers
• Must have experience with either Peptide SPPS/LPPS synthesis or Large Molecule
• Must have experience with characterization testing and comparability assessments
• Must have experience with NDA submissions, authoring for laboratory section and/or review. Experience with both NDA and BLA preferred

Additional Skills/Preferences:

• Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC-RP, Normal Phase, and SEC and GC-HS), spectroscopic, KF, particle size, LOD, appearance, LCMS, GCMS, Bioassay, compendial tests, etc.
• Experience with both NDA and BLA submission preferred (minimum NDA required)
• Ability to work in a lab environment, including wearing appropriate PPE and following safety guidelines.
• Deep understanding of compliance requirements and regulatory expectations.
• Demonstrated accuracy and proficiency in analytical skills.
• Demonstrated strong problem-solving skills. Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology.
• Strong oral and written communication skills demonstrated through documentation and presentations.
• Demonstrated strong interpersonal interaction skills.
• Ability to work in cross functional teams as well as across networks.
• Demonstrated analytical skills.
• Demonstrated experience with method qualification, validation, and transfer.
• Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV).
• Proven ability to support maintenance of Corporate Reference Standards and manage testing and reporting of results from contract manufacturers.

Additional Information:

• Position will be day shift, but may require some shift to support global operations
• May require travel overseas, passport required
• May require up to four days per week person in plant responsibilities for the laboratory in both Hyderabad and Visakhapatnam, India

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

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Experience Level

Senior Level