TSMS- Sr. Scientist

Initial Therapeutics, Inc.; Richmond (VA); On-site; USD 79,500 - 171,600; Full time

Job summary

Lilly is expanding its state-of-the-art GMP manufacturing facility in Richmond, VA and seeks a Senior Scientist for Technical Services/Manufacturing Sciences (TS/MS) Cleaning. The role focuses on supporting the cleaning program for process equipment, developing strategies with Engineering and Quality, and owning the Cleaning Validation Master Plan to ensure compliant operations.

Responsibilities include protocol generation, execution, and batch record development, plus troubleshooting cleaning

Qualifications

• BS degree in Biochemistry, Biotechnology, Chemical Engineering or related discipline.
• A minimum of 3 years of experience within the biopharmaceutical or GMP industry.
• Authorized to work in the United States on a full-time basis; visa sponsorship is not provided.

Responsibilities

• Support the cleaning program for process equipment and ancillary components in the manufacturing facility.
• Provide technical support for introducing and supporting biologics manufacturing processes from startup through routine operations.
• Develop cleaning strategy in collaboration with Engineering and Quality counterparts for the 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).
• 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.

Education

BS in Biochemistry, Biotechnology, Chemical Engineering or related discipline

Tools

CIP skids

Parts washers

Cleaning validation

Job description

Overview

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.

Position

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

As our biologics pipeline continues to expand, Lilly 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.

Responsibilities

• Support the cleaning program for process equipment and ancillary components in the manufacturing facility.
• Provide technical support for introducing and supporting biologics manufacturing processes from startup through routine operations.
• Develop cleaning strategy in collaboration with Engineering and Quality counterparts for the 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).
• 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 the cleaning program.
• Complete 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, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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, recirculated 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 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; occasional evening or weekend support may be required in a manufacturing support function.

EEO and Inclusion

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. This is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. 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). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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