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Principal scientist, tsms contamination control strategy - adn ramp team

Limerick
Hispanic Alliance for Career Enhancement
Principal scientist
Posted: 6 May
Offer description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees worldwide work to discover and bring life-changing medicines to those in need, improve disease understanding and management, and contribute to our communities through philanthropy and volunteerism. We prioritize our work and people.
Organization Overview:
We make a difference globally by discovering, developing, and delivering medicines that help people live longer, healthier, and more active lives. We also support communities through innovative solutions, philanthropy, and volunteer efforts.
Position Brand Description:
The Lilly Scientist - API/Dry Product Network role is expanding to meet new product demands, with several greenfield sites under construction. These sites are staffed for steady-state production, but additional surge capacity is needed for site start-up and ramp-up to full capacity.
The ADN RAMP team is a cross-functional group bringing manufacturing expertise to support site start-ups through Operational Excellence, troubleshooting, and surge capacity. This role offers opportunities to work at new sites, expand the Lilly network, develop technical and leadership skills, and contribute to accelerating Lilly's service to patients.
Success involves supporting site start-ups through technical execution, coaching, collaboration, and developing local teams for full operation. The team reports to the Ramp Team Sr. Director.
Key Objectives/Deliverables:

Develop, implement, and monitor the Contamination Control Strategy (CCS) for new facilities, including:

Facility/Utility Controls: Design, validate, and maintain environmental monitoring and support validation of clean utilities.
Material Controls: Support microbiological control strategies for raw materials and vendor management.
Equipment Controls: Coordinate with validation groups on microbial requirements and support qualification activities.
Product Controls: Ensure microbiological requirements are integrated into product strategies and support trend analysis and deviation management.

Coach and mentor site CCS teams on program implementation and maintenance.
Support industry trend updates and guideline compliance.
Support multiple sites, with flexibility for travel and international assignments.
Basic Requirements:

BSc in Microbiology, Biochemistry, or related field with 8-10 years' experience, or
MSc in Microbiology, Biochemistry, or related with at least 5 years' industry experience.

Additional Skills/Preferences:

Deep understanding of Contamination Control Strategy.
Excellent communication, analytical, and problem-solving skills.
Collaborative mindset and ability to influence without authority.
Ability to coach others and simplify complex issues.
Willingness to work off-shift hours and travel as needed.

Other Information:
The role involves supporting multiple sites across locations, with potential international travel and relocations. Lilly is committed to diversity and inclusion, offering accommodations and supporting employee resource groups. Compensation varies based on experience and location, with additional benefits and a comprehensive package.
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