Eli Lilly and Company · 5 hours ago
Principal Scientist, TSMS Contamination Control Strategy - ADN RAMP Team
Indianapolis, IN
Full-time
Hybrid
Senior Level, Lead/Staff
$64K/yr - $167K/yr
5+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering and delivering life-changing medicines. The Principal Scientist will be responsible for developing and implementing the Contamination Control Strategy for new site facilities, ensuring microbiological safety and compliance in pharmaceutical manufacturing processes.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Responsible for the development, implementation and establishing ongoing monitoring of the Contamination Control Strategy (CCS) for new site facilities including but not limited to:
In collaboration with the New Site CCS team, design, implement, support validation of and maintenance of routine and Batch Specific environmental monitoring (EM) programs
Where necessary, design, implement, support validation of Clean Utilities microbiological monitoring programs
Support aseptic qualification /requalification programs
Liaise with engineering on the New Facility design requirements to support CCS such as but not limited to pressurization cascades, area classification, material, personnel and equipment flows
Provide microbiological control strategy support for Raw Materials
Provide the Microbiological Controls to support the Resin Management programs where necessary
Liaise with Quality Assurance to ensure microbiological controls are considered in the application of Vendor Management such as but not limited to approval of GMP Service providers, risk assessment of GMP Consumables and approval of new raw materials
Liaise with cleaning validation group on microbial requirements for cleaning validation
Provide Microbiological support to C&Q such as but not limited to commissioning and qualification of cGMP autoclaves and Parts Washers (SOP and COP studies) and steam in place (SIP) systems in Biotech facilities
Provide Microbiological support for process support qualification (PSQ) studies such media challenges, Media and Buffer Hold Time Studies and resin lifetime studies
Liaise with Engineering on filtration requirements to support product specific elements of contamination control strategy
Ensure implementation of the microbiological requirements for the integrated product control strategy
Provide direction on handling of non-conforming results
Support Microbiological trend analysis and metrics reporting as required
Member of the deviation response team for management of suspect Microbiological Contamination events
Provide microbiological support for procedural and batch record updates as required
Stay current with Industry trends and updates to applicable guidelines such as ISO standards and GMP requirements within area of responsibility
Coach and mentor site CCS teams on implementation and maintenance of all CCS programs
Qualification
Required
BSc Microbiology, Biochemistry or related science field with 8-10 years' experience in pharmaceutical manufacturing
MSc Microbiology, Biochemistry or science-related field with minimum 5 years appropriate industry experience
Preferred
Deep technical interest and understanding of Contamination Control Strategy
Excellent verbal and written communications skills
Strong analytical and problem-solving skills
Collaborative skills with operations, process engineering, QCL and other process team members
Technical knowledge of microbial and viral product control
Ability to coach others
Ability to influence without authority
Ability to clarify and simplify complex issues
Strong trust building with peers and leaders
Willing to work off-shift hours as needed to support project milestones and training of new employees
Benefits
Company bonus
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (404)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
2025-12-30
2025-12-30
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