TSMS- Sr. Scientist

About the Role

As our biologics pipeline continues to expand, Eli Lilly & Company has invested in a state-of-the-art new GMP manufacturing facility in Richmond, VA. The TS/MS Senior Scientist is responsible for supporting the cleaning program for process equipment and ancillary components in the manufacturing facility. This role will provide technical support for introducing and supporting biologics manufacturing processes from startup through routine operations.

Responsibilities

• Develop cleaning strategy in collaboration with Engineering and Quality counterparts for Lilly Limerick Monoclonal Facility
• Author and own 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
• Troubleshoot issues with and optimize cleaning cycles and/or cleaning equipment
• Provide technical support on cleaning deviations/events and assist in root cause analysis
• Complete changes associated with cleaning equipment, cleaning cycles, and cleaning program
• Complete Periodic Review Reports for key components to ensure cleaning equipment remains in a qualified state

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

Qualifications

• 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 of a 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

This is an onsite role. As a manufacturing support function, the need for occasional evening or weekend support can arise.

Pay

The anticipated wage for this position is $79,500 - $171,600. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Benefits

• Comprehensive benefit program including eligibility to participate in a company-sponsored 401(k) and pension
• Vacation benefits
• Medical, dental, vision, and prescription drug benefits
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• Life insurance and death benefits
• Certain time off and leave of absence benefits
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)