Sr. Principal - Sterility Assurance

Job not on LinkedIn

April 25

Apply Now

Receive Emails with Similar Jobs

Eli Lilly and Company

WebsiteLinkedInAll Job Openings

Pharmaceuticals

Eli Lilly and Company is a pharmaceutical company that engages in the discovery, development, and marketing of products in the pharmaceutical industry. The company's mission is to make life better for people around the world by discovering, developing, and delivering innovative human medicines.

10,000+ employees

Founded 1876

💊 Pharmaceuticals

📋 Description

• 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). • Influence 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. • Aid in building technical capability at Lilly sites to ensure the necessary capabilities are developed and in place to meet business objectives. • Provide ad-hoc technical support to Lilly PR&D, QC Microbiology, external contract manufacturing, and non-sterile drug substance (API) manufacturing. • 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. • 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. • Provide mentoring leadership to site SMEs to help build technical capability, particularly at the newer sites or where deep technical expertise is needed. • Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network. • Engage in providing support during in preparation for and during regulatory interactions.

🎯 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 • 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 • Close interaction with quality to enable internal audits that identify risks • Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options • Ability to influence personnel and management across the organization

🏖️ Benefits

• 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)