TSMS- Sr. Scientist

Biopharma Careers; United States; On-site; USD 80,000 - 172,000; Full time

Benefits offered by this job

Company bonus

401(k)

Medical, dental, vision insurance

Life insurance

Job summary

Lilly, headquartered in Indianapolis, Indiana, is seeking a Senior Scientist to support cleaning processes for biologics manufacturing. The role focuses on developing strategies, validating cleaning programs, and providing technical support across production areas onsite.

The position requires a BS in a related field and 3+ years in biopharma or GMP settings, with eligibility to work in the United States. Onsite roles with potential for weekend coverage are noted.

Qualifications

• BS in biochemistry, biotechnology, chemical engineering or related discipline.
• 3+ years in biopharma or GMP industry.
• Authorized to work in the United States full-time.

Responsibilities

• Develop cleaning strategy with Engineering and QA.
• Own Cleaning Validation Master Plan for the facility.
• Generate cleaning validation protocols and reports.
• Execute cleaning validation protocols and coordinate with operations.

Skills

Strong communication skills

Self-starter

Data-driven problem solving

Team collaboration

Education

BS in Biochemistry/Biotech/Chemical Eng

MS in Biochemistry/Biotech/Chemical Eng (preferred)

Tools

Cleaning equipment

Job description

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.

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

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, 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, 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.

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 ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note 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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