Principal Associate - HSE

Initial Therapeutics, Inc.; Richmond (VA); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Health, dental, vision benefits

Flexible benefits

Life insurance

Leave programs

Well-being programs

Job summary

Lilly is building a new GMP manufacturing site in Goochland County, VA, and seeks an experienced HSE professional to lead the Richmond HSE team in developing and improving the HSE Management System for startup operations.

The role focuses on collaborating across functions, implementing safety programs, and ensuring regulatory compliance as the site scales to full GMP manufacturing. A strong emphasis is placed on training, audits, and culture building.

Qualifications

• Bachelor's degree required in occupational health, safety, engineering, chemistry, biology, environmental health, or a related scientific or technical discipline.

Responsibilities

• Own the development, implementation, and ongoing improvement of the Site HSE Management System and standards.
• Lead the Safety/Health training and communications programs.
• Drive implementation of Safety/Health initiatives and performance metrics.
• Lead site audits, safety culture development, and regulatory audits.
• Collaborate with site manufacturing and technical teams to manage Safety/Health aspects of processes.

Skills

Safety program development

Regulatory interpretation

Collaboration

Training delivery

Auditing

Education

Bachelor's degree in occupational health, safety, engineering, chemistry, biology, environmental health

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly is currently constructing an advanced manufacturing facility for monoclonal antibodies, and bioconjugates in Goochland County, Virginia. This facility is intended to provide capacity for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.

Position Overview:

An exciting opportunity has arisen for an experienced HSE professional to join the Richmond Health, Safety, and Environmental (HSE) team and take a leading role in developing, maintaining, and continually improving the HSE Management System/Program at our new manufacturing site.

In the project delivery and startup phase of the project, the HSE roles will be fluid and dynamic as we endeavor to support project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity, and resilience as the site grows to full scale GMP manufacturing through startup.

Responsibilities

• Own the development, implementation, and ongoing improvement of the Site HSE Management System, including setting its scope, priorities, and standards.
• Develop, integrate, and continuously improve the site Safety/Health program, serving as site program owner for multiple program elements and making independent technical decisions within those areas.
• Serve as the site's recognized technical expert on Safety/Health, interpreting legislation, corporate standards, policies, and industry guidance and advising site leadership on compliance decisions.
• Lead the development of a safety culture with integrated safety practices and open safety conversations.
• Develop and deliver high quality Safety/Health training and communications.
• Drive implementation of site Safety/Health initiatives.
• Understand and implement Safety/Health requirements in a project environment through knowledge of applicable legislation and industry practices.
• Own site Safety/Health performance metrics, analyzing trends and translating findings into corrective and preventive actions.
• Lead site audits and self-assessments, and represent the site in management reviews, corporate audits, and external regulatory audits.
• Collaborate with site manufacturing and technical support personnel to manage Safety/Health aspects of new / established processes.
• Interact with external (e.g., service providers, vendors, consortiums, academia) and internal partners (e.g., Global HSE, other sites in the network, etc) as required.
• Mentor and build the technical capability of HSE colleagues and site personnel, sharing expertise across the network.
• Represent HSE in required Site team and HSE Team meetings, providing input on site decisions.

Basic Requirements:

• Bachelor's degree required in occupational health, safety, engineering, chemistry, biology, environmental health, or a related scientific or technical discipline.
• Minimum of 5+ years of experience within highly regulated GMP manufacturing environments.
• Demonstrated experience independently interpreting and applying Health and Safety regulations and developing Health and Safety programs.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Skills/Preferences:

• Previous experience supporting greenfield, startup, or major capital project environments in pharmaceutical, or other regulated manufacturing settings.
• Excellent organization and time management skills, as well as strong analytical skillsandsystematic and structured way of working
• Strongcollaborationand communication skills
• Demonstrated ability to lead cross-functional and technical teams and to influence and align stakeholders without direct authority

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$65,250 - $169,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including

• 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)

Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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