Associate Director – TSMS Sterility Assurance at Eli Lilly and Company

Pleasant Prairie, Wisconsin, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, HealthcareIndustries

Requirements

Knowledge of cGMPs, applicable global regulatory manufacturing guidance, and corporate/industry standards related to sterility assurance
Understanding of parenteral aseptic processing as it relates to drug product manufacturing, specifically formulation/filling/inspection of pharmaceutical products
Ability to multitask/prioritize
Excellent written and oral communication skills
Decision-making ability
Interpersonal skills
Ability to anticipate potential problems and develop/implement solutions
Ability to work with peer leadership positively to deliver on functional technical objectives, product business plans, and quality objectives

Responsibilities

Oversight of Sterility Assurance organizations supporting Lilly Kenosha County (LKC) parenteral manufacturing
Leading and mentoring a technical staff
Providing guidance on time management and priorities for direct reports
Managing routine production support activities while balancing implementation of technical projects and program oversight
Maintaining a safe work environment, leading safety initiatives, and supporting HSE Corporate and Site Goals
Designing and executing technical and defendable contamination control strategies
Performance management and development of staff
Partnering within TS/MS and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives
Technical review and approval of site GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc
Defining and maintaining inspection readiness activities; interacting with regulatory agencies during inspections regarding cGMP, environmental monitoring, and sterility assurance issues
Networking internally and externally to understand best practices, share knowledge, and participate in tactical and strategic business planning
Maintaining metrics to measure performance against business objectives and making necessary changes to improve performance
Using sterility assurance risk management to evaluate proposed manufacturing processes and associated controls with respect to potential microbial, endotoxin, and particulate contamination
Ensuring site’s environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, sterility assurance risk management, and other sterility assurance programs are followed at the manufacturing floor level

Skills

cGMP

Sterility Assurance

Aseptic Processing

Parenteral Manufacturing

Drug Product Manufacturing

Formulation

Filling

Inspection

Regulatory Compliance

Time Management

Communication Skills

Decision Making

Interpersonal Skills

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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