- Full Time
- Bangalore, Karnataka
Website Lilly
Table of Contents
ToggleAbout Lilly
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 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 put people first. We’re looking for people who are determined to make life better for people around the world.
Job Title: Scientist (Analytical) – Data Steward
Job Description
As a Scientist (Analytical) – Data Steward at Lilly, you will work as an individual contributor on one or more cross-functional project teams within the analytical department. Your responsibilities will include:
- Performing activities for the analysis of a variety of active pharmaceutical ingredients and dosage forms to evaluate stability and support clinical trial materials.
- Testing raw materials and excipients.
- Generating and reviewing release and stability data.
- Qualification, verification, validation, and transfer of analytical methods and techniques to manufacturing sites and third-party testing laboratories.
- Ensuring consistency of analytical testing across sites (both internal and external laboratories) while meeting compliance requirements.
- Applying cGMP practices during execution of routine testing.
- Leading or providing input to investigations using scientific techniques to resolve laboratory-related issues through in-depth problem-solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results.
Key Responsibilities
- Follow all relevant policies, including business, compliance, regulatory (cGMPs), quality, environmental, and safety expectations.
- Make sound technical decisions and communicate these decisions to other scientists and management.
- Demonstrate technical excellence in performing, assessing, and troubleshooting multiple analytical methods.
- Share technical knowledge and key learning openly.
- Efficiently manage project deliverables to support multiple projects at various phases.
- Establish and maintain key relationships within BR&D and Testing Labs.
- Identify internal and external customer requirements and develop solutions to meet their needs.
- Demonstrate proficiency in data review, analysis, reporting, interpretation, and trending, including batch release, stability, and method installation data.
- Exhibit good documentation skills with regard to raw data recording and authoring of documents.
- Participate in investigations to identify root causes and implement appropriate corrective and preventive actions.
- Engage in inspection readiness activities and support regulatory inspections and audits.
- Author and track the implementation of change controls and other compliance requirements relevant to department projects.
- Use scientific expertise to assist with troubleshooting, laboratory investigations, and problem resolution.
- Act as a Subject Matter Expert in instrumentation, methods, and troubleshooting.
Candidate Profile
- BS/MS in analytical sciences or an equivalent pharmaceutical degree with at least 3 years of relevant experience in the analytical field.
- Fundamental knowledge of cGMP compliance requirements and regulatory expectations.
- Strong documentation skills and the ability to author and/or review standards, GMP guidelines, SOPs, templates, protocols, and other documentation.
- Excellent general computer skills (MS Excel, Internet Explorer, PowerPoint, MS Word, JMP) with the ability to compile, summarize, and present information to diverse groups.
- Familiarity with Microsoft Office Tools. Skills in Power BI, Python, and database tools are a plus.
- Ability to troubleshoot problems and identify solutions.
- Customer-focused attitude.
- Experience with various root cause methodologies.
- Good interpersonal skills and ability to work effectively in a team-based environment internally and with external partners.
- Demonstrated learning agility and creative thinking with strong problem-solving skills.
- Highly flexible, adapting to changes in priorities, requirements, and processes.
- Proficiency in complex laboratory analysis, including chromatographic, spectroscopic, immunoassay, DNA, and microbiological assays.
- Ability to work in a lab environment and follow safety guidelines.
Additional Information
- Experience: 3 years
- Qualification: BS/MS in analytical sciences or equivalent pharmaceutical degree
- Location: Bangalore, Karnataka
- Industry Type: Pharma / Healthcare / Clinical Research
- Functional Area: Research & Development
- End Date: 10th August 2024
Join us at Lilly, where you can make a meaningful impact on people’s lives and contribute to groundbreaking discoveries. Apply today!
- For more articles, Kindly Click here.
- For pharmaceutical jobs, follow us on LinkedIn
For more jobs, kindly visit our job section.
To apply for this job please visit careers.lilly.com.