Manufacturing & Production

Eli Lilly and Company

Director, Global Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC), Platform

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

This role provides strategic, tactical and operational regulatory CMC leadership across therapeutic modalities and manufacturing technologies to expedite development of the small molecule portfolio and to support clinical trial applications, market registrations, and post approval submissions. This is accomplished through a strong working knowledge of global regulations, guidelines, and regulatory precedent coupled with deep technical knowledge of CMC development and manufacturing processes.

**Key Responsibilities**

- Deep technical knowledge of small molecule CMC drug development and manufacturing sciences across modalities and platforms (drug substance, drug product, analytical sciences).
- Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations and maintaining approved registrations.
- Development and implementation of innovative regulatory strategies and platform approaches based on changes in external environment (new guidance, evolving expectations, and regulatory precedent).
- Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product lifecycle planning.
- Leads preparation, critical review, and approval of CMC documents for global regulatory submissions and responses, including clinical trial applications, marketing applications, variations/supplements, and health authority information requests.
- Takes a proactive leadership role in the critical review of molecule specific CMC development and lifecycle strategies.
- Provides high quality, timely and clear regulatory advice to allow project teams to make well-informed decisions on development or product lifecycle planning.
- Makes decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members.

**Basic Qualifications/Requirements**

- B.S. degree in a science, engineering, or a STEM related field (advanced degree preferred). Fields of study include Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, or similar.
- 10+ years of Regulatory CMC or technical CMC experience supporting clinical phases of development and/or commercialization of synthetic molecules. Those with greater than ten years of experience are encouraged to apply.

**Additional Skills/Preferences**

- Experience authoring CMC submission content, and involvement in clinical trial applications/marketing authorization application processes including response to questions.
- Knowledge of major market procedures, regulations, and practices. Awareness of evolving regulatory initiatives.
- Relevant experience in synthetic molecule drug substance and/or drug product development, commercialization, or manufacturing.
- Demonstrated deep knowledge of the synthetic molecule drug development process.
- Extensive prior regulatory experience handling complex regulatory submission strategies or equivalent combination of technical and regulatory guidance knowledge and experience.
- Experience planning for and participating in Health Authority meetings.
- Demonstrated ability to assess and manage risk in a highly regulated environment.
- Demonstrated strong written, spoken and presentation communication skills.
- Demonstrated leadership behaviors and negotiation and influence skills.
- Demonstrated attention to detail.
- Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.

**Additional Information**

- Position Location: Indianapolis, IN. A remote option may be considered. Relocation assistance is provided.
- Travel: minimal within the US

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](<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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$148,500 - $257,400

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.

\#WeAreLilly

Indiana

Site Operational Excellence Business Partner

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, bioconjugates, and aseptic drug product manufacturing in Goochland County, Virginia. This facility is intended to provide capacity for current and future products. This is a unique opportunity to be part of the 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.

The Operational Excellence Business Partner provides direct support for OPEX projects in support of the site agenda. This role reports to the Operational Excellence Lead. They partner with the organization to deploy operational excellence standards and support continuous improvement. The Business Partner is an SME in Lean, Problem Solving, Root Cause Analysis, Manufacturing Standards of Operational Excellence, and Human Performance Reliability. The role involves a balance of execution and coaching.

**Key Responsibilities**

- Support the site agenda through direct project execution
- Participate in Flow Team governance, identify trends, and lead improvement initiatives
- Facilitate Operational Excellence training to all levels of employees within assigned areas to support deployment and ongoing sustainability of Operational Excellence / Lean ways of working
- Coach and train teams in Lean tools and systems (for example, daily management, A3 thinking, standard work)
- Participates and/or lead cross functional teams in the development and implementation of strategies associated with the area for the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Human Performance Reliability (HPR), etc.
- Participate in Operational Excellence Assessments within the site (site and globally driven)
- Sustain and evolve Lean maturity and consistency on site
- Empower individuals and teams to use lean behaviors and mindsets to strive for execution excellence
- Lead improvement events and support deployment of Operational Excellence tools in the business including but not limited to systems such as daily management, standard work, A3 thinking, and value stream mapping, RCA, and HPR
- Educate the business on Operational Excellence approaches and partner with leadership to engage all employees in the Operational Excellence journey and ensure the discipline to sustain Lean remains in place
- Serve as Operational Excellence Business Partner by partnering with Business Area Leaders to facilitate the chosen methodology for the given project (for example, Kaizen Event)
- Provide support to ensure robust Organizational Change Management and Monitoring Plans are in place to sustain improvements
- Engage routinely with sponsors to provide status and escalate where appropriate as issues arise
- Ensure lean principles and tools are integrated into both project execution and solution design
- Responsible for assembling Operational Excellence project plans, teamwork assignments, directing and monitoring work efforts daily.

**Minimum Requirements:**

- High School Diploma or equivalent.
- Minimum of 2 years experience in a GMP manufacturing facility
- 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 Preferences:**

- Direct experience in manufacturing operations for drug substance and/or drug product facilities
- Experience in Lean Manufacturing or other Productivity industry methods
- Demonstrated strong written and oral communication and interpersonal interaction skills to be able to work effectively in a team-based environment
- Strong self-management and organizational skills
- Ability to influence without authority
- Ability to coach individuals from the shop floor to Flow Team, and lead project teams

Additional Information:

- Travel: 0-10%

\#LI\_MNLC

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](<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

$60,000 - $143,000

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.

\#WeAreLilly

Virginia

Sr. Director - Supply Chain

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, bioconjugates, and aseptic drug product manufacturing 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:**

The Senior Director, Supply Chain leads site-wide supply chain, warehousing, and logistics operations to ensure reliable product delivery. Responsibilities include planning, procurement, customer service, logistics, SAP master data and systems support, and internal warehousing.

This role translates forecasts into production plans that optimize inventory and manage risk, recommends inventory and safety stock strategies, ensures regulatory compliance, and develops team capabilities through leadership, mentoring, and training.

As a member of the Lilly Site Lead Team, the Senior Director contributes to strategic direction, organizational development, and cross-functional issue management aligned with corporate goals and external dynamics.

During the project delivery and startup phases, leadership roles will be fluid to support project execution, organizational buildout, system implementation, and culture development. This phase will require strong collaboration, creativity, and resilience as the site scales to full GMP manufacturing.

**Key Responsibilities:**

- Lead materials and production planning to ensure product availability and timely shipments.
- Oversee supply chain meetings to resolve delays and shortages.
- Own site-wide planning processes and integrate supply chain needs into strategic and business plans.
- Develop and maintain planning tools (e.g., dashboards, trackers) to support cross-functional decision-making.
- Ensure governance of master data (materials, BOMs, recipes, resources).
- Serve as the primary liaison with the Global Supply Chain organization.
- Manage buying/planning processes and safety stock strategies to meet production requirements.
- Define and track KPIs to measure planning effectiveness and identify improvement opportunities.
- Partner with procurement to address supply chain and vendor-related technical issues.
- Collaborate across the site lead team to align business processes and warehousing with startup and long-term goals.
- Engage with regulators, customers, and external stakeholders, including during audits.
- Promote a strong safety culture across the organization.

- Build organizational capability, capacity, and culture for GMP operations.
- Implement systems and processes, leveraging Lilly best practices and external insights.
- Support regulatory compliance and operational excellence through lean principles.
- Collaborate with the project team to ensure smooth facility handoff and readiness.

**Requirements:**

- Bachelor’s degree required, preferably in supply chain, engineering or related technical function.

- 5+ years’ experience supporting manufacturing operations, in a supply chain capacity, preferably in the pharma industry

- Experience with planning processes, such as demand management, forecasting tools, forecasting processes, manufacturing orders, bills of materials, etc.

- 5+ years of leadership experience building and managing teams

**Additional Preferences:**

- Collaborates effectively in teams while making independent decisions and influencing diverse groups.
- Fosters teamwork and demonstrates strong interpersonal skills.
- Delivers innovative solutions to site, divisional, and corporate challenges by leveraging cross-functional insights.

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](<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

$154,500 - $226,600

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.

\#WeAreLilly

Sr. Director - HSE Manufacturing - API -Virginia

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

*Lilly is currently constructing an advanced manufacturing facility for monoclonal antibodies, bioconjugates, and aseptic drug product manufacturing 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.*

**Main Purpose and Objectives of Position:**

The Senior Director HSE is responsible for developing, implementing, and maintaining HSE programs and systems at the Lilly manufacturing site. This includes oversight of all site operations—manufacturing, labs, utilities, waste, emergency response, and administrative areas—ensuring compliance with global and regulatory standards.

This role leads the site HSE team, supports employee development, and serves as the primary liaison with corporate HSE to ensure alignment and readiness for regulatory inspections.

As a member of the Lilly Site Lead Team, the Senior Director contributes to strategic planning and cross-functional leadership. During the **project delivery and startup phase**, the role will focus on building HSE systems, processes, and culture to support GMP operations and enable a safe, compliant launch of full-scale manufacturing.

Key Responsibilities for this role include:

**Pre-Startup and Startup Phase:**

- Lead collaboratively and inclusively across all aspects of operational readiness and startup.
- Build an HSE organization with the capability, capacity, and culture to support safe, compliant, and efficient operations.
- Define HSE priorities and roadmap; implement systems and processes using internal expertise and external best practices.
- Establish and lead the site HSE Lead Team, embedding safety and environmental focus throughout project delivery and startup.
- Serve as a key HSE stakeholder during project execution—guiding design, startup planning, and contractor safety in partnership with Global Facilities Delivery.
- Develop and scale the HSE organization to support full GMP manufacturing, including environmental and PSM capabilities.
- Build strong technical partnerships with corporate/global teams and lead site-level execution of strategic initiatives.

**Post Startup:**

- Own the HSE Management System to ensure compliance with regulations and Lilly Global standards.
- Define and manage HSE priorities, roadmap, business initiatives, metrics, and the HSE Plan in collaboration with functional partners.
- Ensure ongoing compliance with reporting and recordkeeping requirements, including Title V.
- Benchmark best practices across the Lilly network and external industry.
- Develop future HSE leadership for both site and global roles.
- Escalate critical HSE issues to site and corporate leadership as needed.

**Requirements:**

- Bachelor’s Degree in relevant discipline
- 5+ years of experience leading HSE teams and programs (preferably with PSM experience)

**Additional Preferences:**

- Proven leadership of HSE programs and management systems in manufacturing, including Process Safety Management (PSM).
- Experience implementing and managing environmental compliance programs, including Title V reporting and recordkeeping.
- Skilled in engaging with regulatory agencies on environmental, health, and safety matters.
- Strong ability to build effective relationships across all levels, including close collaboration with the Site Leadership Team.
- Demonstrated success in developing high-performing, engaged teams and fostering a strong safety culture.

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](<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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$156,000 - $228,800

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.

\#WeAreLilly

Principal/Sr. Principal Logistics Engineer

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.

**Description of Role / Position**

The Logistics Engineer is responsible for supporting the design, implementation, and continuous improvement of logistics and material flow systems at the Lilly Richmond manufacturing site. This role supports the build-out and operational readiness of the site's logistics infrastructure—including Automated Storage and Retrieval Systems (ASRS), material conveyance, Autonomous Mobile Robots (AMRs), and SAP Extended Warehouse Management (EWM) integration. The Logistics Engineer works cross-functionally to develop assigned business processes. The role contributes to building a paperless, digitally enabled logistics environment in alignment with Lilly's Next Generation Biotech manufacturing vision.

**Key Responsibilities**

*Project / Start-up Phase*

- Create and maintain a site-level Plan for Every Part (PFEP), incorporating supplier data, SAP bill-of-material and non-BOM items (e.g. reusable containers and pallets), and product usage rates across the Richmond site.
- Support the design and implementation of business processes during the start-up phase.
- Support the set-up, commissioning, and qualification activities for automated material handling systems (ASRS, VSM, AMRs, AGVs, and conveyance equipment).
- Drive lean principles and ensure efficient material flows are maintained throughout the logistics center; support value stream mapping initiatives.
- Develop Logistics Standard Operating Procedures (SOPs) and work instructions in partnership with Operations, Quality, and Safety.
- Partner with maintenance and automation teams to develop a spare parts strategy for logistics equipment.

*Ongoing Operations*

- Responsible for ensuring logistics systems (ASRS, VSM, conveyance, AMRs, AGVs) consistently meet the operational demands of the business.
- Monitor daily system performance metrics and KPIs, identifying trends and driving continuous improvement opportunities.
- Maintain PFEP data throughout the full lifecycle of all production flows to ensure system capacity is not exceeded.
- Work closely with business leaders to anticipate when business demand will approach or exceed logistics system capability and propose solutions proactively.
- Develop and maintain quality systems for logistics and materials management, including SOPs, work instructions, and training materials pertinent to receipt, kitting, shipping, and general warehouse practices.
- Manage change controls and support or lead quality investigations; own work instructions and SOPs governing warehouse equipment.
- Participate in Quality and Safety Time on Floor (TOF) audits; support safety assessments, job hazard analyses, and FMEAs relevant to warehouse operations and material movement equipment.
- Support change and deviation management within the function.
- Provide daily operations support across: (i) receipt of inbound materials, (ii) kitting and replenishment of production materials, (iii) general material flow through the logistics center, and (iv) execution of daily shipments.
- Benchmark emerging materials management and logistics initiatives across the Lilly network and externally.
- Support capital planning for expansion or recapitalization of warehouse systems and equipment.

**Minimum Educational Qualifications / Experience Required**

- Bachelor's Degree (BSc) in Engineering, Supply Chain, Logistics, Science, or a related discipline required.
- Minimum of 3 years' experience in a logistics, materials management, or supply chain engineering role, preferably within pharmaceutical, biotech, medical device, automotive, or FMCG industries.
- Experience with ERP systems required.
- 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**

- MBA or MSc preferred.
- SAP S/4HANA and/or SAP EWM experience strongly preferred.
- Lean Six Sigma experience or certification is desirable.
- Strong analytical and quantitative problem-solving skills with demonstrated ability in root cause analysis and data-driven decision making.
- Experience with automated storage and material handling systems (ASRS, VSM, AMRs, AGVs, conveyance) is highly desirable.
- Solid understanding of GMP requirements as they apply to warehouse and material management operations.
- Understanding of data integrity principles and their application in a regulated manufacturing environment.
- Ability to communicate and influence effectively across functional groups and site stakeholders.
- Demonstrated project management capability; able to coordinate complex, cross-functional initiatives.
- Strategic thinking with the ability to balance short-term operational needs against long-term business evolution.
- Demonstrates continuous improvement mindset; familiar with lean principles and value stream mapping.
- Self-motivated, organized, and able to work proactively with minimal supervision.
- Enthusiasm for change, team spirit, and flexibility to adapt to evolving business needs.

**Additional Requirements / Information**

- This role requires flexibility and the ability to adapt across Materials Management and Warehousing/Logistics workstreams in a state-of-the-art logistics center, including inbound receipts, kitting, management of contract service providers, and shipping execution.

- Ability to travel occasionally during the start-up phase of the project.

- Role may require participation in on-call or off-hours support during key start-up and validation phases.

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](<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

$66,000 - $171,600

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.

\#WeAreLilly

Associate Director - Process Engineering

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.

The Process Engineering Associate Director is responsible for the supervision of the process engineers and engineering technicians that support the daily operations of the facility. The Process Engineering Associate Director is also responsible for the productivity and development of the employees with the purpose of ensuring that reliable and compliant equipment and systems are used in the manufacturing of bulk drug substance. Additionally, the Engineering Associate Director partners to influence and implement within the process engineering organization and across functional disciplines to support the process engineering technical agenda, business plan priorities, and compliance plan objectives.

**Key Objectives/Deliverables:**

**Administrative Leadership**

- Supervise and coach process engineering staff, including completing performance reviews and development plans.
- Staffing including recruiting, resource planning, and succession planning.
- Process engineering work coordination.
- Review and monitor financial performance, commit to meeting targets.
- Develop and implement the Process Engineering Business Plan.

**Operational Excellence**

- Demonstrate a commitment to environmental, health, and safety (including PSM).
- Identify, track, and report key indicators of functional performance.
- Ensure team is operating in a state of substantial compliance.
- Develop and implement Engineering business plan objectives.
- Remove barriers that impact team performance.

**Organizational Capability**

- In coordination with engineering consultants and other IAPI engineering areas, set and reinforce standards for appropriate rigor in engineering work products and utilization of First Principles.
- Assure focus by engineers and completion of critical assignments with appropriate monitoring and reporting.
- Be a fully active member of the flow leadership in running IAPI, including participation on management sub-teams.

**Basic Requirements:**

- Bachelor’s in Engineering or related technical field.
- Minimum of 5 years of engineering manufacturing-related experience, preferably some biosynthetic and/or purification operations experience.
- 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 Preferences:**

- State licensure as a Professional Engineer is not required but is encouraged.
- Ability to instill teamwork within the department and demonstrate key interpersonal skills.
- Ability to function in a team environment as a leader and as a member of management teams.
- Ability to ensure appropriate technical depth and rigor with departmental technical deliverables.
- Successful application of organizational models through recruiting and retention of employees.
- Ability to make decisions independently and to network with others as appropriate.
- Ability to provide innovative solutions to plant, divisional, and corporate issues and leverage ideas from other functional areas.
- Ability to communicate verbally and in writing to various audiences, particularly one-on-one coaching and feedback with direct reports.

**Additional Information:**

- This position serves an 8-hour Monday through Friday work schedule. Situations may arise where off-schedule work, both on-site and off-site, will be required. This position requires availability to respond via cell phone outside of standard business hours as needed.
- Travel: Less than 10% travel on an annual basis.
- Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.

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](<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

$123,000 - $180,400

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.

\#WeAreLilly

Sr Director - HSE Manufacturing

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 designing and building a Next-Generation Parenteral and Device Assembly/Packaging Facility in Lehigh Valley. This is an exciting opportunity to help build and operate a pioneering manufacturing site from the ground up. The new Lehigh Valley facility will be one of Lilly’s most technologically advanced manufacturing sites and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that support safety and quality improvements, increased efficiency, and reduced variability.

**Responsibilities:**

The Senior Director-HSE provides strategic, technical, and administrative leadership for the Health, Safety, and Environmental function at the Lehigh Valley site. This role is responsible for establishing and sustaining the site HSE strategy, management systems, and organizational capability needed to support construction, start-up, and ongoing manufacturing operations. The role includes leadership for regulatory and corporate compliance, HSE systems and programs, talent development, risk reduction, and advancement of an injury free workplace.

As a member of the Site Lead Team, this leader contributes to site strategy, business planning, objective setting, and performance monitoring, while influencing cross-functional decisions that shape site readiness and long-term operational performance.

The successful candidate will bring deep HSE expertise, strong leadership presence, and the ability to build a high-performing organization that partners effectively across the site and broader Lilly network.

**Key Objectives/Deliverables:**

- Serve as a member of the Site Lead Team, contributing to site strategy, priorities, and performance across safety, quality, and operational excellence.
- Build, lead, and sustain a high-performing HSE organization through clear expectations, talent development, succession planning, and accountability for results.
- Establish and sustain an injury free workplace by advancing a strong safety culture, risk awareness, and disciplined execution of HSE programs.
- Develop, implement, and continuously improve the site HSE management system.
- Ensure compliance with internal and external HSE requirements, including permitting, regulatory commitments, corporate standards, and site procedures.
- Build and maintain effective relationships with HSE regulators and lead site interactions during audits and inspections.
- Develop and execute the site HSE roadmap in alignment with business priorities and start-up milestones.
- Partner with Corporate HSE and collaborate with HSE peers across Lilly manufacturing sites to share best practices and strengthen site capability.
- Establish local employee health services in collaboration with Human Resources.
- Develop, establish, and sustain systems, processes, and programs that support the transition from construction to start-up and routine operations.
- Partner with construction and design-build firms to ensure a smooth and compliant handoff from construction to start-up.
- Provide leadership and technical direction for all HSE activities at the site, including industrial hygiene, industrial safety, and environmental programs.
- Understand and support HSE event, CAPA, and change control processes, and influence application of the hierarchy of controls to reduce risk and improve outcomes.
- Leverage knowledge of severe injury risk to drive prevention, strengthen awareness, and increase HSE capability across the site.
- Ensure prompt closure of regulatory commitments and site actions related to HSE observations, events, and inspections.

**Basic Qualifications:**

- Bachelor of Science in a scientific, engineering, or HSE discipline.
- Significant HSE experience, including experience in manufacturing environments.
- Experience with CAPA systems for HSE changes, deviations, and corrective actions.
- Strong written and verbal communication skills in English.
- On-site presence required.

**Additional Skills/Preferences:**

- Strong HSE regulatory knowledge.
- Demonstrated technical and organizational leadership skills.
- Strong communication, interpersonal, and computer skills.
- Demonstrated experience building and leading teams.
- Greenfield or site start-up experience preferred.
- GMP operational experience.

**Leadership Differentiators:**

- Demonstrated success building and leading high-performing HSE organizations through construction, start-up, or significant operational change.
- Proven ability to develop leadership bench strength, technical capability, and organizational readiness across a complex site function.
- Experience leading through cross-functional complexity, including balancing compliance, risk reduction, business priorities, and long-term capability building.
- Ability to influence beyond the function, aligning stakeholders across Operations, Quality, Human Resources, Corporate HSE, and external partners.
- Demonstrated judgment in setting priorities, removing barriers, and driving execution in a fast-paced and evolving site environment.
- Demonstrated success supporting daily site performance through strong application of HSE systems, event management, CAPA, change control, and risk reduction practices.
- Experience translating HSE strategy into site-level execution through strong talent leadership, cross-functional partnership, and disciplined operational follow-through.

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](<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

$163,500 - $239,800

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.

\#WeAreLilly

Pennsylvania

Lab Operations Manager- Process and Synthesis labs

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.

**Overview:**

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**Organization:**

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

In the Project Delivery Phase and Startup Phase of the project (2025 to 2028), 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. This will require significant collaboration, creativity, and resilience as the Lilly Medicine Foundry goes from design, start-up, and to steady-state operations.

**Position Overview**

The Lab Manager, Synthesis PTE Synthesis Laboratories, is responsible for leading the day-to-day operations, safety, compliance in the synthetic molecule laboratories at the Foundry . This role ensures that the laboratories are operationally ready to support process development, technology transfer, scale-up activities, characterization studies, troubleshooting investigations, and manufacturing campaign support activities.

The Lab Manager partners closely with Process scientists, Quality Control, Manufacturing, Engineering, Facilities, Health Safety Environment (HSE), Lab Informatics, IT, Supply Chain, and Equipment Support teams to ensure laboratories remain operationally ready and aligned with business priorities. The position provides leadership for laboratory administrative operations, equipment lifecycle management, resource planning, and continuous improvement initiatives.

**Key Responsibilities**

**Laboratory Operations & Readiness**

- Lead daily administrative operations of process and synthesis laboratories, ensuring safe, efficient, and compliant execution of laboratory activities.
- Drive laboratory readiness for new programs, equipment and supporting utility installations, and facility expansions.
- Coordinate vendors and contractors while managing and maintain inventory.
- Serve as the primary point of contact for laboratory operational issues and escalations.

**Safety, Quality & Compliance**

- Champion safety culture and ensure compliance with requirements.
- Ensure laboratory activities comply with applicable quality standards as required.
- Maintain inspection readiness and support internal and external audits.
- Applies 5S and ALCOA principles to maintain an organized, compliant, and inspection-ready laboratory environment.

**Equipment, & Inventory Management**

- Oversee laboratory equipment lifecycle management, including installation, qualification, calibration, maintenance, and retirement.
- Partner with Engineering and Equipment Support teams to ensure equipment reliability and availability.
- Manage laboratory inventory, consumables, solvents, reagents, reference standards, and critical materials.
- Drive implementation and sustainment of laboratory asset management and equipment registry systems.

- Build a high-performing laboratory organization focused on safety, quality, and operational excellence.
- Establish training and qualification programs to ensure personnel competency.

**Strategic & Cross-Functional Leadership**

- Collaborate with cross-functional organizations.
- Develop labor, equipment, and budget forecasts aligned with business needs.
- Identify operational risks and implement mitigation strategies.
- Lead continuous improvement initiatives focused on productivity, reliability, digitalization, and data-driven decision making.
- Ability to balance scientific objectives with business priorities.
- Excellent decision-making, problem-solving, and risk management skills

**Basic Qualifications**

- Bachelor's degree in chemistry or biology or related scientific discipline.
- Minimum 5+ years of experience in pharmaceutical, chemical, biotechnology, or process development laboratories.
- Demonstrated experience managing laboratory operations in a regulated environment.
- Ability to work in a laboratory environment requires safe handling of chemicals, wearing appropriate PPE, and understanding other safety-related equipment or considerations.

*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.*

**Preferred Qualifications**

- Experience supporting technology transfer and scale-up of synthetic molecule processes.
- Knowledge of GMP, GLP, process safety, and laboratory compliance requirements.
- Experience with digital laboratory systems (ELN, MES, LIMS, equipment management platforms).
- Project management and cross-functional leadership skills.

**Other Information**

- Initial location at Lilly Technology Center, Indianapolis and/or Parkwood West

- Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.

- Flexibility to work from Indianapolis (or other Lilly sites) may be required throughout 2026 through 2029.

- Position requires on-site presence, 8-hour days, five days per week, with flexibility to support activities during shutdowns, weekends, etc.

- 0–10% travel required.

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](<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

$66,000 - $154,000

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.

\#WeAreLilly

Senior / Principal Associate QA API External Manufacturing

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.

**Job Summary:**

Eli Lilly and Company is seeking a highly motivated and experienced Senior / Principal Associate QA API External Manufacturing to ensure the quality and compliance of externally manufactured Active Pharmaceutical Ingredients (APIs) in accordance with cGMP regulations and company standards. This role will involve significant oversight and collaboration with external manufacturing partners.

**Job Responsibilities:**

\* Serve as the primary Quality Assurance point of contact for assigned API external manufacturing sites, fostering strong collaborative relationships.

\* Review and approve manufacturing documentation, including master batch records, executed batch records, deviations, investigations, CAPAs, change controls, and OOS reports, to ensure cGMP compliance and product quality.

\* Participate in and lead quality audits of external manufacturing partners to assess compliance with cGMPs, regulatory requirements, and internal quality systems.

\* Oversee and approve critical quality events, including significant deviations, investigations, and CAPAs, ensuring timely and effective resolution.

\* Collaborate with internal cross-functional teams (e.g., Supply Chain, Regulatory Affairs, Technical Services) to support new product introductions, technology transfers, and continuous improvement initiatives at external manufacturing sites.

\* Monitor key quality metrics and performance indicators for assigned external manufacturers, identifying trends and implementing corrective actions as needed.

\* Contribute to the development, implementation, and maintenance of quality agreements with external manufacturing partners.

\* Ensure all externally manufactured APIs meet Eli Lilly and Company's quality standards and regulatory requirements for release.

\* Support regulatory inspections and provide responses to regulatory inquiries related to external manufacturing activities.

\* Maintain current knowledge of cGMP regulations (e.g., FDA, EMA) and industry best practices relevant to API manufacturing and external supply chain quality.

**Job Qualifications:**

\* Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, or a related scientific discipline.

\* Minimum of 5 years (Senior Associate) or 8 years (Principal Associate) of experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry, with a strong focus on API manufacturing and/or external supply chain quality.

\* In-depth knowledge of cGMP regulations (e.g., 21 CFR Part 210/211, ICH Q7) and international quality standards applicable to API manufacturing.

\* Proven experience in auditing external manufacturing sites and managing quality events (deviations, investigations, CAPAs).

\* Strong understanding of analytical testing methods, stability programs, and release criteria for APIs.

\* Excellent communication, interpersonal, and negotiation skills, with the ability to effectively collaborate with diverse internal and external stakeholders.

\* Demonstrated ability to work independently, prioritize tasks, and manage multiple projects simultaneously in a fast-paced environment.

\* Strong problem-solving and decision-making abilities with a keen attention to detail.

\* Proficiency in English; additional language skills are a plus.

\* Ability to travel domestically and internationally as required (up to 25%).

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](<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; 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.

\#WeAreLilly

Engineer - Process

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**Organization Overview**

The Engineer – Process is responsible for establishing and maintaining the reliable operation and qualified state of the equipment and business processes in the area that they support. The engineer engages with cross-functional support teams as an equipment/automation subject matter expert to ensure the business meets defined safety, quality, and productivity goals. The engineer also ensures that systems and platforms are in-control, compliant, and capable of meeting customer needs, while delivering projects associated with regulatory compliance, commercialization, capacity, and continuous improvement efforts.

**Core Responsibilities**

- Ensure a safe working environment by following safety rules and helping improve safety culture.
- Actively participate in safety-related activities (audits, JSA’s, hazard reviews, etc.) to drive ongoing safety improvements.
- Responsible for the safe design and safe operation of the equipment within the area.
- Ensure that systems/solutions are in-control, capable, and compliant throughout the area.
- Demonstrate technical expertise of processes/equipment in area of responsibility, including clear understanding of equipment flow, process flow, critical process parameters, and standard operating procedures for the processes.
- Lead troubleshooting efforts to resolve difficult equipment and operational issues.
- Utilize formal problem-solving techniques, including Root Cause Analysis, to resolve and communicate equipment issues.
- Engage with original equipment manufacturers and other service vendors to build knowledge base and deliver on projects and troubleshooting efforts.
- Communicate effectively with others, especially project team members, process team members, operations, maintenance, and crafts personnel.
- Perform impact assessments for varying levels of changes to responsible equipment/systems.
- Establish control systems and monitor/trend, as tool to verify and optimize equipment performance.
- Understand equipment reliability issues with the objective of process improvement.
- Identify and drive improvements associated with equipment within the area.

**Basic Qualifications:**

- Bachelor’s degree in an engineering field, with preference to Mechanical or Electrical Engineering disciplines.
- 1+ years of engineering experience in a GMP or highly regulated environment
- *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 pharmaceutical manufacturing, parenteral, and/or packaging processes.
- Experience in Commissioning & Qualification, asset delivery, validation activities, and cGMP regulations.
- Demonstrated ability to communicate effectively to customers, business partners, and staff including good oral, written, and visual presentations.
- Experience utilizing and implementing various tools, systems, and processes resulting in improved operational excellence.
- Proficiency in working cross-functionally with other areas of Indianapolis Parenteral Manufacturing to deliver on highly complex tasks that may have aggressive timelines.

**Additional Information:**

- 8-hour dayshift work schedule.
- Must be willing to work extended hours during peak periods.
- Must be willing to respond to off-hour support needs, as necessary.
- Occasional travel may be required for project delivery activities, training, conferences, capital projects, etc.

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](<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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$66,000 - $171,600

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.

\#WeAreLilly

Advisor – Process Engineer. Lilly Medicine Foundry

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

The Lilly Medicine Foundry Process Engineering organization is responsible for the chemistry, formulation, analytical, and engineering efforts to support development and scale-up of investigational small molecules to support clinical and toxicology studies through late-stage clinical trials. The Advisor – Process Engineer will serve as a senior technical authority within this organization, providing expert-level engineering guidance across the full lifecycle of process development, scale-up, and manufacturing support for the Foundry's small molecule node. This is a unique opportunity to be part of the startup team for a greenfield manufacturing site and to shape the processes, equipment, and engineering culture that will enable a successful transition to GMP manufacturing operations.

Responsibilities

Under the direction of the Process Engineering leadership, the Advisor – Process Engineer:

- Understands and complies with corporate, divisional, and departmental procedures, including good manufacturing practices, safety, and other applicable regulations, and participates in the establishment and maintenance of the Foundry's Quality systems.

- Serves as the technical authority for equipment design and scale-up calculations across the Foundry's small molecule node, spanning both established and emerging modalities. Typical responsibilities include:

- Leading detailed engineering calculations, heat and mass transfer modeling, and equipment sizing to support the design of production suites for small molecule, peptide, oligonucleotide, and other new modality processes.

- Performing and directing rig-fit assessments for incoming processes, using process simulation tools (e.g., DynoChem, Aspen) to validate that reactor geometries, mixing performance, heat transfer, and pressure ratings are appropriate for scale-up to the kilo lab and pilot plant.

- Providing expert guidance on the selection and design of reactor systems for a diverse range of chemistries, including batch and semi-batch reactions, continuous flow unit operations, hydrogenation (fixed-bed, slurry, and high-pressure systems), peptide synthesis reactors (SPPS), and oligonucleotide synthesis platforms.

- Driving scale-up from laboratory and kilo lab to full pilot plant production, ensuring heat and mass transfer, mixing, and process safety considerations are rigorously evaluated and documented at each scale transition.

- Leading P&ID reviews for relevant design packages and communicating design intent and basis across engineering disciplines, vendors, and partner functions.

- Developing and maintaining manufacturing processes and control strategies for drug substance APIs, with particular emphasis on translating development-scale chemistry into fit-for-purpose equipment specifications.

- Providing expert guidance on the preparation of manufacturing and controls sections of INDs, CTX filings, regulatory submissions, and annual updates.

- Authoring and ensuring timely completion of high-quality technical reports, basis-of-design documents, and engineering specifications. Ensures records and technical notebooks are adequately maintained.

- Demonstrates the Lilly Leadership behaviors, as defined in the Lilly Performance Management system.

- Plans and manages short-term and long-term development activities within the Process Engineering function. Assigns work, coordinates efforts, evaluates progress, and reviews the activities of engineers and scientists assigned to the group.

- Develops and reviews plans and timetables for project work. Recommends resource allocation to accomplish projects according to plans, communicates progress, and proposes changes to project timetables, objectives, or direction.

- Takes a leadership role in ensuring departmental compliance with all applicable laws, regulations, guidelines, procedures, and practices governing drug research and development, including departmental and corporate standard operating procedures, good manufacturing practices, and safety procedures.

- Provides active engagement and communication with cross-functional partners including HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Maintenance, and Manufacturing.

- Ensures that people and their environment are safe and that company policies concerning safety are followed. Leads and participates in Process Hazard Reviews, HAZOPs, thermal hazard assessments, and other safety evaluations applicable to high-pressure, flammable, and novel modality processes.

- Trains and mentors process engineers at all levels on equipment design principles, scale-up methodologies, GMP procedures, and Foundry-specific technical requirements across modalities.

Basic Qualifications

- PhD in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or a related discipline. OR

- B.S. or M.S. in Chemical Engineering or a related discipline with 10+ years of experience in pharmaceutical, biotech, or CMO process engineering supporting drug substance API development or manufacturing.

**Additional Skills and Preferences**

- Deep technical expertise in chemical engineering fundamentals and pharmaceutical process development, including reaction chemistry, crystallization, extraction, distillation, and other unit operations relevant to small molecule API manufacturing.

- Strong knowledge of and experience in project management in a cross-functional pharmaceutical development environment.

- Demonstrated leadership capabilities, especially in team environments with diverse scientific and engineering disciplines.

- Good interpersonal skills and demonstrated collaborative abilities with internal and external partners.

- Demonstrated success in persuasion, influence, and negotiation with stakeholders at all levels of the organization.

- Excellent verbal and written communication skills, with the ability to convey complex technical information to diverse audiences including operations staff, management, and regulatory agencies.

- Breadth of previous SMDD or equivalent pharmaceutical R&D and manufacturing experience preferred.

- Preferred experience with cGMP manufacturing and process support in a pilot plant or clinical manufacturing environment.

- Ability to prioritize multiple activities simultaneously and manage ambiguity in a fast-paced startup environment.

- Ability to influence others and promote a positive, high-performance work environment.

- Demonstrated initiative and risk-taking in tackling novel technical challenges.

- Demonstrated technical proficiency and ability to translate technical and scientific information into actionable plans, resource strategies, and project budgets.

- Experience with process simulation tools (e.g., DynoChem, Aspen) and process control systems (e.g., DeltaV) preferred.

**Other Information**

- Initial location at Parkwood West, Indianapolis, IN.

- Permanent location at the Lilly Medicine Foundry, Lebanon, Indiana.

- Limited domestic and international travel (\< 10%) may be required.

- Role requires the ability to work in 24-hour manufacturing and laboratory environments.

- Role is classified at the R5 (Advisor) level within Lilly's Engineering job family.

*Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.*

*#WeAreLilly*

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](<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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$129,000 - $189,200

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.

\#WeAreLilly

Associate Director - Operations Process Lead

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.

We are seeking a highly motivated and experienced Process Lead to optimize and manage operational processes within Eli Lilly Radioligand Therapies. This role will drive continuous improvement initiatives, ensuring efficiency, compliance, and excellence across our manufacturing and supply chain operations.

**Responsibilities:**

- Analyze processes to identify bottlenecks and implement solutions that improve efficiency, quality, and waste reduction.
- Lead design, development, and continuous improvement of operational processes in compliance with cGMP and regulatory requirements.
- Own process documentation (SOPs, work instructions, process flow diagrams) and validation activities, including strategy, protocols, and approvals.
- Lead and participate in root cause analysis, CAPAs, deviations, investigations, and change controls to support compliance performance.
- Partner cross-functionally with HSE-RS, TSMS, Manufacturing, QA, and Supply Chain to ensure seamless process integration and execution.
- Support internal and external audits, ensuring timely closure of quality and safety compliance activities.
- Track and report KPIs/metrics, identifying trends and recommending adjustments to meet business objectives.
- Provide technical guidance and mentorship to junior engineers and operational staff, fostering a culture of continuous improvement.

**Basic Qualifications:**

- Bachelor's degree in Engineering (Chemical, Industrial, Biomedical, or related field), Pharmaceutical Sciences, or a related scientific discipline.
- 7+ years of experience in process engineering, operations management, or a similar role within pharmaceutical or biotechnology manufacturing; experience with RLT (Radioligand Therapy) highly preferred.

**Additional Preferences**

- Proven track record leading process improvement initiatives with measurable results, including experience with process validation and change control.
- Strong knowledge of cGMP, FDA guidelines, and relevant industry standards.
- Proficiency in process mapping, SPC, Lean, and Six Sigma methodologies (Green/Black Belt certification a plus).
- Strong analytical, problem-solving, and decision-making abilities.
- Excellent communication and interpersonal skills, with the ability to lead and influence cross-functional teams.
- Proficiency with relevant software tools (e.g., process simulation, data analysis, project management).

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](<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

$118,500 - $173,800

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.

\#WeAreLilly

Associate Director - Radioligand Therapies Operations Lead

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.

Eli Lilly and Company is seeking an experienced and dynamic Radioligand Therapies Operations Lead to drive the operational excellence and strategic growth of our radioligand therapy programs. This role is pivotal in ensuring the efficient development, manufacturing, and supply chain management of innovative radiopharmaceuticals, ultimately bringing life-changing treatments to patients.

**Job Responsibilities**

- Develop and optimize processes across research, development, manufacturing (internal/external), and supply chain.
- Lead day-to-day operations for radioligand therapy programs, ensuring alignment with corporate strategy, regulatory requirements, and timelines.
- Partner with R&D, Clinical, TS/MS, Regulatory, Quality, Manufacturing, and Supply Chain to ensure seamless execution and on-time milestones.
- Select, qualify, and manage vendors for manufacturing and logistics, including SLAs and performance metrics.
- Drive continuous improvement in efficiency, cost, and risk management across the portfolio.
- Manage budgets and resource allocation, ensuring financial stewardship.
- Track the evolving radiopharmaceutical landscape — regulatory shifts, technology, and competitive intelligence.
- Champion safety, quality, and compliance across all operations.
- Represent operations in cross-functional and leadership forums.
- Mentor junior staff to build a high-performing team.

**Basic Qualifications:**

- Bachelor's degree in a scientific, engineering, or other relevant industry field.
- 7+ years of experience in pharmaceutical operations, with at least 2 years specifically focused on radiopharmaceuticals or nuclear medicine.

**Additional Preferences:**

- Strong grasp of radiopharmaceutical manufacturing, supply chain (cold chain, hazardous materials), and quality control.
- Track record leading complex operations in GMP/GDP/GCP environments.
- Familiarity with global regulatory guidelines (FDA, EMA, Health Canada).
- Skilled at building relationships and influencing stakeholders at all levels.
- Strong project management, problem-solving, and decision-making skills.
- Excellent written, verbal, and presentation/negotiation skills.
- Experience with vendor management and contract negotiation.
- Willing and able to travel domestically and internationally.

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](<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

$123,000 - $180,400

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.

\#WeAreLilly

Process Engineer, Kilo and High Potency Lab, Lilly Medicine Foundry

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.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**About the Lilly Medicine Foundry:**

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

**Organizational Overview:**

Lilly is currently constructing an advanced research facility for production of API molecules for clinical trials located in Lebanon, IN. This facility is Lilly’s largest investment in a clinical trial manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.

We are seeking a Process Engineer to support the pilot plant facility in Lebanon, with a focus on small molecule Kilo Lab and High Potency Lab operations. This position involves solving technical challenges with kilo-scale reactor and scale-up equipment design, developing and sustaining process knowledge for both standard and high-potency (HPAPI) chemistries, optimizing processes across synthesis, crystallization, distillation, and isolation unit operations, and managing equipment capabilities and containment strategies for the Kilo Lab and High Potency Lab suites.

**Responsibilities**

The Process Engineer provides technical assessment and support for production operations in the areas of developing and sustaining process knowledge, process and equipment support, process optimization, equipment capability and asset management, and engineering business systems. This role is to serve as a process engineer supporting drug substance active pharmaceutical ingredient (API) manufacturing within the Kilo Lab and High Potency Lab.

- Evaluate scale-up feasibility and rig fit for new chemistries by analyzing technical data packages and running kinetic, mass-transfer, and heat-transfer modeling and experiments to ensure clean transfer from gram- to kilogram-scale reactors.

- Design, test and install new equipment to meet the evolving portfolio and reaction needs.

- Design, operate, and troubleshoot kilo-scale reactor systems — glass-lined and Hastelloy reactors, agitated filter-dryers — partnering with Kilo Lab and High Potency Lab chemists and shaping plant design for piping, mixing, heat transfer, and automation.

- Engineer containment and safe-handling strategies for HPAPI operations, spanning isolator and glove-box systems, occupational exposure banding (OEB), and dry-end solids processing.

- Optimize crystallization, distillation, extraction, and isolation unit operations, resolving polymorphism and particle-size challenges while closing mass balances and tracking impurity fate and purge across multi-step syntheses.

- Safeguard quality, safety, and cGMP compliance across equipment and procedures, and author or review technical reports, regulatory submissions, and lab notebooks to a high standard.

- Drive cross-functional execution by conducting impact and risk assessments, coordinating with HSE, QA, Tech Services, Development, Operations, Automation, and Manufacturing, and developing project plans and timetables with a proactive quality mindset.

- Develop or review plans and timetables for project work.

**Basic Requirements:**

- BS or MS in chemical engineering or related discipline and a minimum of 1-4 years of experience with a pharmaceutical, biotech, or CMO environment supporting the process engineering of drug substance active pharmaceutical ingredient (API) manufacturing or development.
- 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 Preferences:**

- Deep technical interest and understanding in the field of process development and chemical engineering

- Ability to work well in a team environment incorporating a variety of functional relationships and desire to be point of accountability

- Experience with any of the following software packages: DeltaV, Dynochem, Aspen, and/or electronic lab notebooks

- Experience with kilo-scale equipment (e.g., glass-lined/Hastelloy reactors, agitated filter-dryers) and understanding of scale-up factors including kinetics, mass transfer, and heat transfer

- Familiarity with high-potency API (HPAPI) handling, containment equipment (isolators, glove boxes), and occupational exposure banding (OEB) practices

- Working knowledge of key organic chemistry unit operations (crystallization, distillation, extraction) and analytical techniques (HPLC/UPLC, MS, NMR, GC, KF, DSC, XRD) Experience supporting small molecule process chemistry scale-up from gram to kilogram scale in a cGMP environment

- Working knowledge of bioconjugate unit operations including single use, TFF and chromatography.

- Strong analytical and problem-solving skills

- Strong oral and written communication skills for a diverse audience, e.g., both operations staff and management.

- Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science and engineering professionals

- Understanding of process control systems

- Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented

- Guidance/mentoring of others through processes

- Flexibility to meet business needs

Other Information:

- Initial location at Parkwood West, Indianapolis.

- Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

\#WeAreLilly

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](<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

$66,000 - $171,600

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.

\#WeAreLilly

Post-Doctoral Scientist — Technical Services/Manufacturing Science (TS/MS)

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.

**Responsibilities**

Post-Doctoral Scientists at Lilly are responsible for:

- Ensuring reliability of our manufacturing processes and systems
- Continuously searching for, developing and implementing improvements
- Driving technical projects in a rigorous manner for robust implementation
- Maintaining our processes in a state of compliance with US and global regulations
- Designing and developing drug processes and delivery systems

The position is a post-doctoral scientist position in the Technical Services/Manufacturing Sciences (TS/MS) organization and is available beginning January 1, 2027. It provides technical and scientific support within a dynamic manufacturing environment. They will lead the technical development and commercialization aspects for parenteral drug products to ensure process robustness and capability across multiple scales. The successful candidate will be responsible for designing and executing experiments to advance product and process knowledge, process optimization and production technical transfer, as needed. TS/ MS scientists actively contribute to the organization, and have extensive opportunities for involvement in cross-functional teams. This position allows for development of a comprehensive understanding of the pharmaceutical industry, current Good Manufacturing Practices (cGMP), regulatory requirements, and the essential role scientists play in creating solutions for Eli Lilly and Company and the patients we serve.

**Key Objectives/Deliverables:**

- Understand the chemistry and stability (including oxidation/degradation pathways) of peptides and biomolecules.
- Develop appropriate laboratory-scale models to assess manufacturing changes.
- Understand the scientific principles required for bioproduct manufacturing of drug substances and drug products, including the interaction of molecule/solution chemistry with process equipment, drug product containers, and/or delivery systems.
- Design, conduct, and analyze statistically designed experiments to deepen process understanding and optimize processing conditions.
- Understand scale-up requirements and as needed, partner with the manufacturing sites to conduct appropriate scale-up work.
- Provide technical support to process development areas as needed.
- Document all work in an appropriate manner.
- Mentor lab associates enhance their technical capabilities.
- Participate in technology transfer as needed.
- Travel 0 – 10%

**Basic Qualifications Requirements:**

- Ph.D. in scientific disciplines of Chemistry, Materials Chemistry, Chemical Biology or closely related field.
- 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**

**Desired Experience:**

- Functional understanding of organic chemistry as applied to stability of peptides and biomolecules and characterization methods (preferred)
- Understanding of first principles that may impact absorption/desorption properties of various materials of construction.
- Demonstrated record of scientific achievement
- Demonstrated problem solving abilities
- Ability to work well independently, as well as in teams
- Strong written and oral communication skills

**Additional Information**

This Post-Doctoral Scientist position is not permanent. It is for a fixed duration of two years, with potential to extend to three years, for a maximum of up to four years. Candidates will have the opportunity to apply for full-time positions after the duration is completed.

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](<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

$58,000 - $123,200

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.

\#WeAreLilly

Director Early Phase Process Chemistry SMDD

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.

The Synthetic Molecule Design and Development (SMDD) team is involved in key activities for the development of synthetic active pharmaceutical ingredients (API) from pre-clinical phases through commercialization of drug substances and drug products. Our chemists, engineers, and scientists develop key technical and business solutions across the portfolio using their deep technical expertise to accelerate testing of the clinical hypothesis and overall drug development. SMDD delivers on these responsibilities by recognizing diverse talent and cultures are vital to bring the next generation of life changing medicines to patients.

**Position Summary:**

Our team is looking for experienced and creative individuals to lead synthetic molecule route commercialization as well as process optimization and unit operation definition of drug candidates to support clinical trials, product commercialization, and regulatory submissions. The position presents an opportunity to lead dynamic teams comprised of process chemists, analytical chemists, formulation scientists, and engineers. Additionally, candidates will provide oversight for external R&D, tech transfer, and campaign execution.

**Responsibilities:**

- Demonstrate a deep expertise and demonstrated capability with utilization of modern synthetic organic and process chemistry techniques to address key CMC challenges
- Lead and/or supervise the design and development of new synthetic routes for the manufacture of API using the most modern technologies
- Exhibit a high learning agility with the ability to understand and exploit new scientific concepts and methods across multiple fields; be able to apply these takeaways to a portfolio of small molecule, oligonucleotide, and synthetic peptide, and other emerging synthetic modalities
- Possess solid understanding in unit operation design, process modeling, process equipment selection, and scale-up methodologies; build and apply groundbreaking technology and novel platforms within a time constrained environment
- Lead a cross-disciplinary team to evaluate and refine new manufacturing routes, manufacturing technologies, and practices to deliver an exciting portfolio
- Provide technical leadership in the scale-up and demonstration of new chemical processes in development and commercial scale equipment; collaborate in technology transfer activities to CRO/CMO organizations and internal Lilly manufacturing nodes to ensure processes are technically robust, well developed and characterized, and safe
- Design experimental laboratory plans in support of route and process design, definition, optimization, and technology transfer objectives.
- Ability to integrate process (and property design) data based on a fundamental understanding of the underlying physical processes
- Apply advancements in technology (PAT) and modeling platforms to understand and lead experimental protocols. Leverage high throughput experimental platforms to accelerate reaction discovery.
- Plan and lead short term and long-term development activities; develop and/or review technical agendas and timelines for project work; advise resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.
- Collaborate across internal CMC networks (Drug Product Delivery, Project Management, Quality, Manufacturing, and Regulatory) to implement and deliver material and information for clinical trials and regulatory submissions.
- Possess deep understanding of the external global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing authorization applications
- Embrace diversity in thoughts, background, and experiences through supervision, mentoring, and development of a diverse scientific staff to deliver solutions. Encourage team members to take initiative and accountability to achieve goals and draw out and encourage others to share knowledge on challenging technical issues
- Actively collaborate and exhibit influence in the external scientific environment and demonstrates an ability to recognize and integrate external innovation across the Lilly synthetic portfolio

**Minimum Qualifications:**

- Ph.D. in organic chemistry, or a related field with 10+ years of pharmaceutical process development experience OR MS in Organic Chemistry or related field with 15+ years' experience.

**Additional Skills/Preferences:**

- Experience within the pharmaceutical sector is preferred; however, other experience may meet expectations. Prior experience in active ingredient development and associated formulated product is acceptable. Relevant industrial sectors would include agrochemicals, nutraceuticals, specialty chemicals, and personal care products. Experience with developing chemical processes from mid-development cycle (proof of concept) to product commercialization.
- Experience with technical transfer of processes into manufacturing operations
- Experience with authoring regulatory submissions and responding to regulatory questions
- Established external reputation and strong publication record
- Knowledge and experience with management of a technical project and ability to build ideas for future work plans
- Experience with modern analytical techniques and process analytical technologies (PAT)
- Experience with modeling and simulation tools, data analytics, and predictive analytics
- Ability to transform ideas into marketable products and processes
- Demonstrated leadership capabilities, good communication skills and a sustained tendency for collaboration
- Ability to prioritize multiple activities and handle ambiguity
- Ability to influence others to promote a positive work environment

**Additional Information:**

- Potential exposure to chemicals, allergens, and loud noises.
- Travel: 0 to 10%
- Position Location: Indianapolis, IN; Lilly Technology Center-North (LTC-N)

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](<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

$148,500 - $257,400

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.

\#WeAreLilly

Novo Nordisk

Sr. QA Specialist - Pharmaceutical Manufacturing

**About the Department**

Site New Hampshire, located in West Lebanon, is where Novo Nordisk’s life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It’s not your average production site – it’s a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We’re looking for individuals who are self-starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

**The Position**

This position is responsible for working together with the management team to set future quality direction and supporting the implementation of our ambitious goals by bringing the best practices from other Novo Nordisk sites. The person in this role will be responsible for performing reviews/approving of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all site bioloigics produced. This position has QA signature authority on the review of individual batch records, supporting test records and other ancillary support records. Responsibility for developing and coaching QA colleagues as well as supporting manufacturing by being present on the manufacturing floor. This role will help drive implementation of quality improvement projects, and support cross functional projects across the site.

This role is based onsite at our West Lebanon, NH bio-production facility Monday-Friday. Our facility is a 24/7 commercial scale GMP manufacturing facility.

**Relationships**

Reports to: Sr. Director, QA

**Essential Functions**

- Responsible for training, mentoring and developing other QA colleagues
- Responsible for identifying and assessing training needs and delivering training materials and programs, to include training of team members on compliance related issues and other QA related topics
- Serve as Good Manufacturing Practice (GMP) expert that responsible for evaluating and improving the effectiveness of training programs
- Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, internal audits of the facility, and deviation issues
- Informing stakeholders regarding project goals and deliverables
- Consult and mentor across business operations and provide specialized knowledge
- Reviews and assesses Deviations, including evaluation, tracking, follow-up, and reporting / trending
- Reviews and approves Validation Documentation
- Reviews and assesses Corrective and Preventive Action Reports
- Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations, and industry codes
- Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others
- Other duties as assigned

**Qualifications**

- Education and Certifications:
  - Bachelor’s Degree within a scientific or life science required
  - Master’s Degree preferred
- Work Experience:
  - Bachelor’s Degree with ten (10) years experience required
  - Master’s Degree with eight (8) years experience preferred
  - Six (6) years of direct QA experience preferred

- Knowledge, Skills, and Abilities:
  - Excellent written and verbal communication and negotiating skills in English are required
  - Strong planning and organization skills, with flexibility for changes in work priorities
  - Must be able to exercise judgment within defined practices and policies to determine appropriate action to be taken
  - Normally receives no instructions on routine work, and general instructions on new assignments. Determines and develops approach to solutions
  - Ability to work on complex Quality projects where analysis of data requires evaluation of identifiable factors
  - Ability to train and/or mentor Junior team members in QA Best Practices
  - Extensive knowledge in GMP API manufacturing in the pharmaceutical Industry
  - Have proven experience with GMP manufacturing in the pharmaceutical industry
  - Have good stakeholder management skills and collaboration skills at all levels of the organization

**Physical Requirements**

Local and International Travel: 0-5%. While performing this job employee work involves sitting most of the time with walking and standing required only occasionally. This position may lift up to 10 pounds occasionally or constantly to lift, carry, push, pull or otherwise move objects. Visual a to perform close activities such as: reading, writing, and analyzing.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

New Hampshire

Health & Safety Professional III - API manufacturing

**About the Department**

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

Our new Petersburg, Virginia site marks a strategic move to advance our capabilities in Emerging Technologies (ET) within Chemical API development and production. The highly experienced site is designed to strengthen and accelerate our Small Molecule (SMOL) strategy while amplifying our operational capacity. This is to safeguard and support ET´s SMOL projects in the coming years, aligning with our vision and strengthening our potential for growth and innovation.

What we offer you:

- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including 14 paid holidays
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

Contribute to the development of Health & Safety (EHS) processes/systems for the site. Write & review specifications, participate in process hazard evaluations, SOP development, safety programs development & training. Provide leadership & support in attaining a safe working environment, provide direct support for the site, technical direction for Safety Professionals & maintain & report safety data. Ensure positive working relationship with internal & external stakeholders & alignment/collaboration with Corporate Health & Safety groups. Drive the safety processes for the site.

**Relationships**

Reports to Sr Manager.

**Essential Functions**

- Provide technical direction to site personnel as it relates to management of safety processes, working in high hazard environments, & ensuring safety compliance
- Coordinate industrial hygiene programs to ensure compliance to applicable exposure limits
- Champion all safety requirements in the performance of duties across the site
- Creation & implementation of safety programs, objectives, and targets
- Support Project execution & compliance through risk assessments, development of corrective actions & coordination of improvements
- Provide safety expertise & solutions for resolving known or potential issues
- Provide safety training & tools for core processes to improve safety performance
- Communicate safety performance statistics on a monthly/weekly basis
- Review all recordable accidents & coach root cause analyses, corrective & preventive actions for assigned departments
- Provide back up for emergency management/fire systems
- Increase the awareness of safety through various communication tools
- Support development of Health & Safety Professionals I and II and EHS Representatives
- Responsible for the site’s ISO45001 Health & Safety Management System and internal and external-related audits
- Follow all safety & environmental requirements in the performance of duties
- Other duties as assigned

**Physical Requirements**

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role.

**Qualifications**

- Bachelor's Degree in Environmental Health & Safety, Safety Management, or a relevant field of study from an accredited university required
  - May consider an Associate’s Degree in Environmental Health & Safety, Safety Management, or a relevant field of study from an accredited university with a minimum of seven (7) years of experience in safety required, preferably in a pharmaceutical manufacturing environment
  - May consider a High School Diploma or equivalent with a minimum of nine (9) years of experience in safety required, preferably in a pharmaceutical Manufacturing environment
- Minimum of five (5) years of experience in safety required, preferably in a pharmaceutical manufacturing environment
- Working knowledge of ISO45001 required
- Knowledge in Industrial Hygiene and Worker’s Compensation Management required
- Knowledge & experience in emergency management / planning required
- Able to develop & manage action plans to achieve targets required
- Strong skills in root cause analysis for analyzing accidents & process incidents preferred
- Knowledge in classified electrical environments preferred
- Pharmaceutical experience a plus
- Good verbal & written communication skills required
- Working knowledge of fire detection/suppression/prevention systems a plus

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Facility Management Associate II - PS AM (DPM Expansions)

**About the Department**

You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk’s 50,000 employees.

FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.

What we offer you:

• Leading pay and annual performance bonus for all positions

• All employees enjoy generous paid time off including **14 paid holidays**

• Health Insurance, Dental Insurance, Vision Insurance – effective day one

• Guaranteed 8% 401K contribution plus individual company match option

• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave

• Free access to Novo Nordisk-marketed pharmaceutical products

• Tuition Assistance

• Life & Disability Insurance

• Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

Provide & coordinate maintenance & services to the facility in a cost-effective manner.

**Relationships**

Reports to Manager, Facilities & Utilities Maintenance.

**Essential Functions**

- Follows all safety & environmental requirements in the performance of duties
- Assists in management & execution of contracts for services while improving value
- Maintains the facility & responds timely to building maintenance requests
- Responsible for physical condition of building & grounds
- Responsible for planning & performing work relating to general repair of buildings such as installing & relocating building or office fixtures & minor repairs to building, walls, floors, stairs, general carpentry, etc
- Routinely audits building & parking lot cleanliness & maintenance
- Works independently on projects of greater complexity
- May provide direction to less experienced staff
- Participates with spill response & first aid teams in coordination with EHS
- Updates Facility Management share-point site & records
- Supports execution of shipping, receiving & non-GMP warehouse tasks as needed
- Provides back up support for waste management
- Other accountabilities, as assigned

**Physical Requirements**

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Ability to be on feet for up to a 12-hour shift. May require corrected vision to 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. Occasionally performs critical job functions in extremely cold work environments. Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment. Ability to work in loud noise environments with hearing protection. Occasionally works in outdoor weather conditions. Able to pass a driving exam for powered industrial trucks. Does not require a valid driver’s license.

**Qualifications**

- Associate's Degree in engineering, business or planning, or an equivalent combination of education & experience a plus
- Minimum of seven (7) years of experience in facilities maintenance or similar field preferred
- Building maintenance knowledge/experience required
- Knowledge of security systems a plus
- Basic knowledge of OSHA regulations preferred
- Participation in emergency response teams a plus
- Pharmaceutical experience a plus
- Good communication & writing skills a plus
- Valid driver’s license & ability to drive box truck for movement of materials between NN sites a plus
- Microsoft Office skills (Outlook, Word, Excel, etc.) preferred
- Ability to develop & manage action plans to achieve targets preferred

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

North Carolina

Site Services Lead - Security (DPM Expansions)

**About the Department**

You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk’s 50,000 employees.

FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.

What we offer you:

• Leading pay and annual performance bonus for all positions

• All employees enjoy generous paid time off including **14 paid holidays**

• Health Insurance, Dental Insurance, Vision Insurance – effective day one

• Guaranteed 8% 401K contribution plus individual company match option

• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave

• Free access to Novo Nordisk-marketed pharmaceutical products

• Tuition Assistance

• Life & Disability Insurance

• Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

Lead the site services systems to provide maintenance & services to the facility in a cost-effective manner.

**Relationships**

Reports to Manager, Site Services.

**Essential Functions**

- Follow all safety & environmental requirements in the performance of duties
- Negotiate & manage all major contracts for services while improving value
- Proactively manage the facility upkeep & respond timely to building maintenance requests
- Manage security contractors to protect critical areas & employee safety
- Participate with spill response & first aid teams
- Manage housekeeping contractors & proactively maintain facility cleanliness
- Manage pest control contractor & program
- Maintain Site Services SharePoint site & records
- Ensure all records are maintained for audit readiness
- Manage all deviations & audit NCs for the Site Services areas of responsibility
- Provide back up support for waste management & fire protection systems
- Other accountabilities, as assigned.

**Physical Requirements**

May move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 12-hour shift. May required corrected vision to 20/20 or 20/25 based on role. May require colour vision based on role. May require the ability to work in loud noise environments with hearing protections.

**Qualifications**

- Bachelor's Degree in engineering, business or planning, or equivalent combination of education & experience preferred
- Minimum of 5 years in facilities maintenance including system ownership required
- Minimum of 2 years in negotiations of contracts & contract management required
- Building Maintenance knowledge/experience required
- Knowledge of security systems preferred
- Contract negotiations/contract management required
- Management of various fulltime contractors required
- Basic knowledge of OSHA regulations preferred
- Participation in emergency response teams a plus
- Pharmaceutical experience a plus preferred
- Good communication & writing skills a plus
- Working knowledge of fire detection/suppression/prevention systems preferred
- Able to develop & manage action plans to achieve targets preferred

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.