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.

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 industry (e.g. filling technology, contamination control, Annex 1 interpretation)
• Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities
• Strong written and oral communication skills
• Understanding of cGMP’s, policies, procedures, and guidelines relating to sterility assurance
• Ability to maintain a safe work environment, working safely and accountable for supporting all HSE Corporate Goals
• Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed
• Support the establishment of a sterility assurance network or hub in global TSMS
• Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance
• Work with engineering SME’s to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance
• Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options
• Strong capability to influence personnel and management across the organization
• Close interaction with quality to enable internal audits that identify risks
• Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance

Additional Information:

• Approximately 25% travel (domestic and international)

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

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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