Principal Scientist, TSMS Contamination Control Strategy - ADN RAMP Team

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a dedicated Scientist to contribute to the development of life-changing medicines. This role involves implementing Contamination Control Strategies and collaborating with engineering teams to ensure operational excellence. With opportunities for personal and professional growth, you will play a critical role in supporting multiple sites across the US and internationally. If you are passionate about improving lives through innovative solutions and thrive in a dynamic environment, this position offers a unique chance to make a significant impact.

Benefits

401(k)

Health Insurance

Paid Time Off

Wellness Programs

Qualifications

• 8-10 years of experience in pharmaceutical manufacturing.
• MSc with at least 5 years' experience in related field.

Responsibilities

• Develop and monitor the Contamination Control Strategy for new sites.
• Support validation and microbiological monitoring programs.
• Mentor site teams on program implementation.

Skills

Contamination Control Strategy

Microbiological Control

Analytical Skills

Problem-Solving Skills

Communication Skills

Education

BSc in Microbiology

MSc in Microbiology

Job 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 work to discover and bring life-changing medicines to those in need, improve understanding and management of diseases, and give back to communities through philanthropy and volunteerism. We prioritize our work and put people first. We seek individuals determined to improve lives globally.

Organization Overview:

At Lilly, we serve an extraordinary purpose by discovering, developing, and delivering medicines that help people live longer, healthier, more active lives. We also focus on supporting communities through philanthropy and volunteerism.

Position Brand Description:

The Lilly Scientist - API/Dry Product Network is expanding rapidly to meet demand for new products, with several new greenfield sites under construction. These sites are staffed for full-scale, steady-state production, but additional surge capacity is needed for site start-up and ramp-up to full capacity.

The Scientist - ADN RAMP team is a cross-functional group that brings deep manufacturing expertise to support site start-up through operational excellence, troubleshooting, and surge capacity. This role offers opportunities to work at new sites, enhance technical and leadership skills, and develop strategies to accelerate site start-up across Lilly.

Key Objectives/Deliverables:

1. Develop, implement, and monitor the Contamination Control Strategy (CCS) for new site facilities, including facility/utility controls, material controls, equipment controls, and product controls.
2. Support validation, qualification, and microbiological monitoring programs.
3. Collaborate with engineering on facility design to support CCS.
4. Provide microbiological control strategies for raw materials and vendor management.
5. Support sterilization and equipment validation activities.
6. Ensure microbiological requirements are integrated into product control strategies and support trend analysis and incident management.
7. Mentor and coach site CCS teams on program implementation and maintenance.

Basic Requirements:

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

Additional Skills/Preferences:

• Deep understanding of Contamination Control Strategy and microbiological product control.
• Excellent communication, analytical, and problem-solving skills.
• Ability to collaborate, influence, and coach others.
• Flexibility to work off-shift and travel as needed.

Other Information:

This role supports multiple sites across the US and internationally, requiring mobility and flexibility. Lilly is committed to diversity and inclusion, providing accommodations for applicants with disabilities. Compensation varies based on experience and location, with benefits including a 401(k), health insurance, paid time off, and wellness programs.