Eli Lilly and Company · 2 weeks ago
Sr. Principal/Advisor – Sterility Assurance
Indianapolis, IN
Full-time
Onsite
Senior Level, Lead/Staff
$114K/yr - $198K/yr
5+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. They are seeking a Sr. Principal/Advisor in Sterility Assurance to provide oversight and maintain harmonization of technical programs governing sterility assurance control strategies across the Lilly Parenteral Product Network.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
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
Qualification
Required
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
Preferred
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
Benefits
Company bonus (depending, in part, on company and individual performance)
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)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
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Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
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