Lilly Hiring! Scientist (Analytical) – Data Steward Role For Pharmaceutical Sciences, Apply Online
Lilly Hiring! Scientist (Analytical) – Data Steward Role For Pharmaceutical Sciences, Apply Online. Interested and eligible applicants can check out all of the details on the same below:
Scientist (Analytical) – Data Steward
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full Time, Regular
R-67990
Organization Overview:
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, USA. Our 39,000 employees worldwide 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.
Key Responsibilities:
- Awareness, understanding, and following all relevant policies relating to this job including business, compliance, regulatory (cGMPs), quality, environmental, and safety expectations. Makes sound technical decisions, and appropriately communicates these decisions to other scientists and management.
- Demonstrates technical excellence at performing, assessing, and troubleshooting multiple analytical methods. Displays comprehensive knowledge of instrument set-up, operation, and troubleshooting (e.g., HPLC, CE, ELISA, qPCR, Bioassay, Karl Fischer, UV, compendial, and parenteral tests – particulates).
- Openly shares technical knowledge and key learning.
- Efficiently and effectively manages project deliverables to provide support for multiple projects at multiple phases.
- Establishes and maintains key relationships within BR&D and Testing Labs.
- Identifies internal and external customer requirements and develops solutions to meet customer needs.
- Demonstrates proficiency at data review, analysis, reporting, interpretation, and trending (e.g., Empower, NuGenesis (eLN)) including batch release, stability, and method installation data.
- Demonstrates good documentation skills with regard to raw data recording and authoring of documents.
- Participates in investigations to adequately identify root causes and implement appropriate corrective and preventative actions to prevent recurrence. Utilizes technical writing strategies to ensure content is clear, concise, and complete.
- Participates in inspection readiness activities and supports regulatory inspections. Participates in internal/external audits as needed.
- Authors and tracks the implementation of change controls and all other compliance requirements relevant to department projects.
- Uses scientific expertise to assist with troubleshooting, laboratory investigations, OOT/OOS/aberrant data, and problem resolution. Participates in the root cause analysis and improvement of processes with technical and non-technical solutions that help to improve efficiencies within the department and prevent the reoccurrence of deviations. Develops investigational testing protocols in support of analytical investigations and performs/oversees testing as required.
- Subject Matter Expert in instrumentation including installation, operation, and performance qualifications of instrumentation. SME in methods and troubleshooting.
Educational Requirements:
BS/MS in analytical sciences, or equivalent pharmaceutical degree with at least 3 years relevant experience in the Analytical field.
Experience Requirements:
For the above activities, an individual in this role requires:
- Fundamental knowledge of cGMP compliance requirements and regulatory expectations.
- Good documentation skills and 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) and 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 nice to have.
- Ability to troubleshoot problems and identify solutions.
- Customer-focused attitude.
- Experience with a variety of root cause methodologies.
- Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment internally and with external partners.
- Demonstrated learning agility, and ability to think creatively, try new ideas and apply learnings and strong problem-solving skills.
- Highly flexible, adapting to changes in priorities, requirements, and processes.
- Demonstrates proficiency in complex laboratory analysis including, but not limited to chromatographic, spectroscopic, immunoassay, DNA, and/or microbiological assays.
Ability to work in a lab environment and follow safety guidelines.
