Sr. Principal - Sterility Assurance

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)