Lilly is currently constructing an advanced manufacturing facility for the production of API bioconjugates and monoclonal antibodies (mAb), including new modalities, in Goochland County, Virginia (Richmond, VA). This facility is intended to provide capacity for current and future products. This is a unique opportunity to be part of the leadership/startup team for a greenfield manufacturing site, and the successful candidate will help build the organization, the facility, and the culture to enable a successful startup into GMP manufacturing operations.
Position OverviewThe Sr. Principal Associate - Environmental is part of the Lilly Richmond Health, Safety, and Environmental (HSE) team and serves as the site's recognized technical authority for environmental compliance, setting direction for the development, implementation, and maintenance of environmental programs and leading site permitting efforts.
In the project delivery and startup phase of the project, the HSE roles will be fluid and dynamic as we endeavor to support the 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.
Post start-up, this role will continue to serve as the senior subject matter expert accountable for assigned environmental programs and provide independent compliance oversight of operations for pharmaceutical API/mAb manufacturing units.
Key Responsibilities- Own, develop, and lead implementation of the environmental operational readiness plan for the Lilly Richmond facility as a collaborative, inclusive, and energetic member of the HSE team. Examples of site environmental programs that this role may support include the Title V air program, wastewater, refrigerants, non-hazardous and hazardous waste (RCRA), SPCC, and DOT/hazardous materials, among others.
- Partner with the project team as the accountable environmental stakeholder, shaping and endorsing environmental-related design decisions, construction, and startup plans while ensuring decisions meet project deliverables and compliance requirements, leveraging existing Lilly knowledge and incorporating external experiences and learning.
- Develop and roll out environmental programs, procedures, tools, and overall management systems, including training, coaching, and onboarding of new staff to build technical capability and a strong HSE culture at the site.
- Lead the partnership with Operations, Maintenance, and Engineering functions to govern change, assure safety and compliance of new systems, and set the requirements to assure a safe and compliant startup.
- Ensure applicable internal and external regulatory reporting is coordinated and completed on time, including incorporating second-person verification, as needed.
- Serve as the recognized expert for the operational areas, enabling them to understand and apply the regulatory requirements of their areas and programs; work with them to implement solutions that comply with these regulations and programs. Facilitate the implementation of programs and permits.
- Monitor and interpret emerging regulations and Lilly Global HSE standards, assess site impact, and drive implementation plans in advance of effective dates.
- Lead internal HSE assessments and support incident investigations, including root cause analysis, and set the multi-year improvement plan for assigned environmental programs.
Basic Requirements- Bachelor's degree in environmental engineering, chemical engineering, chemistry, or a related field of study
- Minimum 5 years of experience in chemical manufacturing or a GMP-regulated environment
- Experience applying environmental regulations and developing environmental programs
- Experience interfacing with HSE-related regulatory agencies
- 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- Experience in the pharmaceutical industry
- Excellent organization and time management skills, as well as strong analytical skills and a systematic and structured way of working
- Strong collaboration and communication skills
- Demonstrated ability to lead and influence cross-functional and technical teams without direct authority
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; and 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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