Analytical Technical Steward-Small Molecule

Eli Lilly and Company; Indianapolis (IN); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking an Analytical Technical Steward to ensure quality control in pharmaceutical manufacturing. This role involves reviewing analytical data, leading investigations into discrepancies, and collaborating with cross-functional teams to enhance laboratory practices. The ideal candidate will have a strong background in laboratory analysis, particularly in chromatographic and spectroscopic techniques, and a deep understanding of regulatory compliance. If you are passionate about improving health outcomes through quality assurance and possess excellent problem-solving skills, this opportunity could be your next career step in a dynamic and impactful environment.

Qualifications

• Bachelor's degree in a science field required.
• 5+ years of experience in pharmaceuticals in a GMP lab.

Responsibilities

• Perform technical review and release of analytical data from contract manufacturers.
• Lead investigations for out of specification results and recommend solutions.
• Coordinate testing needs across sites for batch release and stability.

Skills

Analytical Skills

Problem-Solving Skills

Communication Skills

Laboratory Analysis

Regulatory Compliance

Education

Bachelor's Degree in Science

Tools

HPLC

GC

GMP Analytical Equipment

Job description

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.

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. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.

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 small molecule focused. 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.
• Participates in method validations according to Global Quality Standards.
• 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 for marketed products.
• Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies.
• Improve assays in QC.
• 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.
• Method transfers to Contract Manufacturers.
• Oversee transfer 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.

Basic Requirements:

• Bachelor's Degree in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmacy)
• 5+ years of industry related experience in pharmaceuticals in a GMP lab

Additional Skills/Preferences:

• Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC and GC), spectroscopic, KF, particle size, LOD, appearance, compendial tests, etc.
• 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.
• 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.
• Proven ability to provide QC support for contract manufacturers of starting materials, intermediates, and APIs.
• Proficient in establishment and maintenance of GMP or CS mode analytical equipment.
• 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 up to approximately 20% of travel overseas, passport required.