TSMS- Sr. Scientist

Senior Scientist - Technical Services/Manufacturing Sciences (TS/MS) Cleaning

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

As our biologics pipeline continues to expand, Eli Lilly & Company has invested in a state-of-the-art new facility in Richmond, VA. To support this exciting new GMP manufacturing facility and ensure a safe and successful start-up, we are seeking talented individuals to contribute to establishing Lilly Richmond as a reliable supplier of our innovative medicines and furthering our goal of making a difference to people's lives.

The TS/MS Sr. Scientist is responsible for supporting the cleaning program for process equipment and ancillary components in the manufacturing facility. The role will provide technical support for introducing and supporting biologics manufacturing processes from startup through routine operations.

Key Responsibilities

• Develop cleaning strategy in collaboration with Engineering and Quality counterparts for Lilly Limerick Monoclonal Facility
• Author and owns the Cleaning Validation Master Plan for the facility
• Generate cleaning validation protocols and summary reports
• Execute cleaning validation protocols, including visual inspection and sampling and coordination with other support groups (e.g. operations, maintenance, lab, etc.)
• Author cleaning procedures and associated work instructions for all equipment
• Develop cleaning batch records or appropriate documents to enable execution of cleaning activities on the production floor
• Complete review of executed cleaning batch records/documentation
• Trouble-shoot issues with and optimize cleaning cycles and/or cleaning equipment
• Provides technical support on cleaning deviations/events and assist in root cause analysis.
• Completes changes associated with cleaning equipment, cleaning cycles and cleaning program.
• Completes Periodic Review Reports for key components to ensure cleaning equipment remains in a qualified state

Basic Requirements

• BS in Biochemistry, Biotechnology, Chemical Engineering or related discipline
• A minimum of 3 years of experience within the biopharmaceutical or GMP industry
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role.

Additional Preferences

• MS in Biochemistry, Biotechnology, Chemical Engineering or related discipline
• Technical knowledge of cleaning equipment (CIP skids, Parts washers, etc.) and cleaning regimes (chemical, re-circulated washing, etc.)
• Knowledge of qualification/validation requirements and good documentation practices
• Knowledge of biologics manufacturing processes and understanding of production schedules
• Strong written and verbal communication skills
• Ability to work on own initiative and as part process team consisting of a diverse group of management, production/science and engineering professionals.
• Demonstrated technical capability with high productivity.
• Self-starter with high initiative and data-driven approach to problem-solving.
• Demonstrated strong interpersonal skills.
• Demonstrated adaptability and flexibility to working in different environments and teams.

Work Environment

• Onsite
• This is an 8-hour day role. As a manufacturing support function, the need for occasional evening or weekend support can arise.

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