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Sr. Principal - Sterility Assurance
Job 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)