Senior Director - HSE (API New Site)

Chester, Maryland, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, BiotechnologyIndustries

Requirements

A Bachelor's Degree in a relevant discipline is required, along with over 5 years of experience leading HSE teams and programs, preferably with experience in PSM and API manufacturing. Proven leadership of HSE programs and management systems in manufacturing, including Process Safety Management (PSM), is preferred. Experience implementing and managing environmental compliance programs, including Title V reporting and recordkeeping, is also preferred. The ideal candidate will be skilled in engaging with regulatory agencies on environmental, health, and safety matters and possess a strong ability to build effective relationships across all levels.

Responsibilities

The Senior Director HSE is responsible for developing, implementing, and maintaining HSE programs and systems at a Lilly manufacturing site, overseeing all site operations to ensure compliance with global and regulatory standards. This role involves leading the site HSE team, supporting employee development, and acting as the primary liaison with corporate HSE for regulatory inspection readiness. Key responsibilities include building the HSE organization, defining HSE priorities and roadmaps, implementing systems and processes, and serving as a key HSE stakeholder during project execution. Post-startup, the role involves owning the HSE Management System, defining and managing HSE priorities, ensuring ongoing compliance with reporting and recordkeeping requirements, benchmarking best practices, developing future HSE leadership, and escalating critical HSE issues to leadership.

Skills

HSE Management

API Manufacturing

GMP Operations

Regulatory Compliance

Emergency Response

Risk Assessment

Safety Programs

Environmental Compliance

Leadership

Team Development

Strategic Planning

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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