Sr. Principal​/Advisor – Sterility Assurance

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 around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $114,000 - $198,000.

Position Brand

Description:

The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Product Network (PPN). This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance and current expectations, as well as align with business needs.

This role also aids in building technical capability at Lilly sites to ensure the necessary capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, QC Microbiology, external contract manufacturing, and non-sterile drug substance (API) manufacturing.

Key Objectives/Deliverables:

• Support Central TS/MS Sterility assurance initiatives and programs including global quality standard development, sterility assurance work streams, new filling line startup, KPI development, and new regulation assessment.
• Assess differences in current sterility assurance programs across the sites and drive harmonization.
• Work closely with site and cross-functional SMEs to drive alignment.
• Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
• Support TS/MS SA on network and other appropriate governance forums. Ensure that Sterility Assurance programs and alignment topics are frequently presented to network team in order to achieve alignment across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs.
• Provide mentoring leadership to site SMEs to help build capability, particularly at the newer sites or where deep technical expertise is needed.
• Provide technical support to new sites / filling lines during design and start-up activities to ensure sterility assurance programs and process / product requirements are supported.
• Assist in building technical capability in sterility assurance at a site level to enable sustained compliance during commercial activities.
• Provide technical support for significant sterility assurance investigations to help determine root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites.
• Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice.
• Engage in providing support during in preparation for and during regulatory interactions.

Basic Requirements:

• Bachelor's/Master's in a biological science or engineering discipline (Microbiology, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering, etc.)
• 5+ years’ experience working in Parenteral Sterility Assurance / Microbiology or equivalent roles
• Experience in parenteral manufacturing sterility assurance control systems – development of systems, execution and operation of systems, and continuous improvement of systems in a highly regulated environment

Additional Preferences:

• Education discipline focused in microbiology
• Strong technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing…