Manufacturing & Production

Alumis Inc.

Senior Director, Medical Strategy and Operations

Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.

This role will serve as a strategic and operational partner to the Vice President of Medical Affairs and Medical leadership team, and is responsible for ensuring that medical capabilities, processes, systems, and execution models are efficient, compliant, scalable, and aligned with Alumis’ growth strategy. The Senior Director, Medical Strategy and Operations, will be responsible for advancing key initiatives aimed at optimizing and showcasing the impact of the Medical Affairs team. This is a hands-on position that includes driving medical strategic initiatives, enhancing the Medical Affairs systems, supporting critical medical insights processes, and developing innovative solutions to measure and report on medical affairs performance and impact. The role demands an individual who combines scientific knowledge with strong operational leadership to thrive in a fast-paced, agile environment to elevate our medical affairs capabilities.

**Key Responsibilities:**

**Strategic Leadership:**

- Lead and drive the development and execution of initiatives that elevate the strategic and operational effectiveness of the Medical Affairs team in a consistent and scalable manner.

**Medical Affairs Systems Optimization:**

- Oversee the design, implementation, and optimization of our Medical Affairs systems to improve internal efficiencies, engagement and communications with key opinion leaders (KOLs), healthcare providers, and other relevant stakeholders.
- Lead continuous improvement initiatives to enhance efficiency, quality, and compliance across the Medical function.
- Implement best practices for operational metrics, KPIs, dashboards, and reporting to support data-driven decision-making.

**Medical Insights:**

- Collaborate with Medical Affairs Leadership to collect, analyze, and integrate valuable medical insights that inform strategic decisions and optimize the impact of our medical programs.

**Content Management:**

- Serve as Medical Affairs content owner through review and approval process for external-facing materials.

**Cross-functional Collaboration**

- Collaborate with other functional areas such as Clinical Development, Marketing, Market Access, Commercial, Analytics, Compliance, and Regulatory to ensure alignment and integration of medical excellence within the broader organizational strategy.

**Guidance and SOP Development:**

- Leverage expertise to develop guidance documents and SOPs to foster consistency, clarity, and accountability across Medical Affairs.

**Planning, Budgeting & Resource Management**

- Lead medical annual planning, forecasting, and budget management.
- Optimize headcount planning, vendor strategy, and external spend to maximize impact and efficiency.
- Provide transparency and insights into medical investments and their impact.

**Qualifications:**

- **Experience**: Minimum of 10 years in Medical Affairs leadership. Proven experience in managing and optimizing medical operations, systems, content, and medical insights. Experience in a fast-paced, small biotech environment a plus
- **Education**: Advanced degree (PhD, MD, MBA, PharmD or similar)
- **Leadership Skills**: Exceptional leadership abilities with a demonstrated ability to manage cross-functional teams and drive change across complex medical operations. Must have track record of effectively leading without authority
- **Operational Expertise**: Strong experience in developing and managing Medical Affairs dashboards and other qualitative outcomes to measure impact and performance.
- **Strategic Thinking**: Ability to develop and implement strategic initiatives aligned cross-functionally that drive organizational goals and enhance the impact of Medical Affairs functions.
- **Strong Communication**: Excellent communication and interpersonal skills, with the ability to engage and influence stakeholders at all levels, both internally and externally.

The salary range for this position is $265,00 USD to 310,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices degree and background.

Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.

Other benefits include:

- Health insurance premiums paid at 90% for employee, 80% for dependents
- Free access to Genentech Bus & Ferry Share program
- $100 monthly cell phone stipend
- Unlimited PTO for Exempt employees
- Free onsite gym and a kitchen stocked with yummy snacks and drinks!

We are a hard-working, collaborative team on a mission to transform patient’s lives-- and we aspire to **elevate**, **challenge** and **nurture** one another along the way.

**Alumis Inc. is an equal opportunity employer.**

Nationwide

Eli Lilly and Company

Sr. Principal - Industrial Hygienist

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.*

**Main Purpose and Objectives of Position:**

The Industrial Hygienist is part of the Lilly Richmond Active Pharmaceutical Ingredient (API) Manufacturing Health, Safety, and Environmental (HSE) team and provides technical expertise and support in the development, implementation, and maintenance of HSE industrial hygiene (IH) programs and other HSE programs, as needed. This position will serve as the primary IH contact for a variety of areas (e.g., such as monoclonal antibodies and antibody drug conjugates manufacturing, laboratories, utilities, warehouse, etc.).

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

Post start-up, this role will continue to be the subject matter expert and daily support for IH programs and other assigned HSE programs (as needed) within their assigned work areas.

**Key Responsibilities for this role include:**

- Participate in project design meetings, support risk assessment and industrial hygiene/exposure control decisions.
- Responsible for developing and implementing industrial hygiene written programs and applicable trainings.
- Develop and support the industrial hygiene implementation strategy working directly with the areas for implementation, troubleshooting, and auditing compliance.
- Participate in the development of the HSE operational readiness plan for the Lilly Richmond API facility as a collaborative, inclusive, and energetic member of the HSE team.
- Be a technical resource for assigned programs (e.g., hazard communication, exposure assessment, biological safety, personal protective equipment, etc.).
- Conduct workplace assessments to identify chemical, physical, and biological hazards, and develop IH prioritized monitoring plans (e.g. chemical, noise monitoring, ergonomics, and other assessments). Conduct the analysis of exposure assessment results and prepare reports on findings.
- Develop a partnership with Operations, Maintenance, and Engineering functions to help manage change, assure safety and compliance of new systems, and assist in setting requirements to assure safe and compliant startup.
- Be a resource to the operational areas in helping them understand the regulatory requirements of their areas and programs; work with them in implementing solutions that comply with these regulations and programs.
- Complete internal HSE audits/assessments, lead/support incident investigations, assist with trending HSE data and metrics compilation, and support the development of long-term plans to drive program improvements.

**Requirements:**

- Bachelor’s degree in Industrial Hygiene or related field
- 3+ years of Industrial Hygiene experience within cGMP manufacturing (pharmaceutical or chemical manufacturing preferred)
- Experience in GMP Manufacturing environment and potent compounds.
- 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:**

- Experience in antibody drug conjugate manufacturing (drug substance and drug product).
- Demonstrated skills in technical expertise and self-motivation.
- Attention to detail and ability to be flexible depending on operational needs.
- Effective communication skills (oral, written, presentation, and negotiation) appropriate for all levels in the organization and a willingness to share information.
- A self-motivated, action-oriented, high-energy team player with demonstrated ability to work effectively in a highly collaborative organizational culture.
- Practices and earns trust and mutual respect.
- High degree of business and personal ethics and integrity.
- Analysis/problem assessment skills, communication (oral and written) skills, information monitoring skills, quality orientation, and teamwork/interpersonal skills.

**Other information:**

- Tasks will require entering manufacturing and laboratory areas, which require wearing appropriate PPE.
- Must carry a cell phone as position will support 24/7 manufacturing operations.
- Onsite position

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

Virginia

Sr. Principal Engineer- Utilities

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

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

The Utilities Engineer is responsible for establishing and maintaining reliable operation and qualified state of clean utility systems and supporting grey systems that support Biotech manufacturing. The Utilities Engineer will ensure that processes are in-control, compliant, and capable of meeting manufacturing needs, while also driving continuous improvement.

**Key Responsibilities:**

- Ensure a safe working environment by following safety rules and helping improve the safety culture.
- Provide clean system engineering expertise as an active member of area team.
- Clean system unit operations and equipment are maintained and are in a qualified and reliable state.
- Establish and/or monitor the critical parameters for all clean systems to ensure that these are in control.
- Lead Troubleshooting efforts to resolve difficult unit operations, equipment and operational issues.
- Evaluate all activities for impact on qualified state of equipment and utilize appropriate tools as necessary.
- Supporting the grey utility

**Facility Start-Up:**

- Provide engineering support to the Global Facility Delivery Team (Lilly’s global large scale capital delivery team) with a strong focus on right first time and on-schedule facility start-up. This includes design reviews, process safety assessments, user requirements, C&Q support, unit operation shakedown and start-up, facility operational readiness.
- Define and own relevant aspects of the overall integrated operational readiness plan (e.g. SOP development, maintenance strategy, automation optimization, pre-startup safety reviews, alarm requirements, performance qualification requirements/protocol development, etc.)
- Own the qualified state of equipment for respective area of responsibility
- Develop and implement unit operation and equipment control strategy to sustain and optimize utilities systems in support of manufacturing operations
- Support initial operations training requirements as the equipment and area SME

**Safety:**

- Take responsibility for the safe design and safe operation of the equipment within the area.
- Actively participate in safety-related activities (audits, hazard reviews, pre-start up safety reviews) to drive ongoing safety improvement.

**Bio-process Technical Support:**

- Be the point of contact and be the technical expert for equipment and processes in area of responsibility. This includes clear understanding of unit operations and associated equipment operations.
- Monitor the utility systems and optimize the unit operations and equipment performance.
- Lead troubleshooting efforts relating to unit operations, equipment and operational issues.
- Utilize formal problem-solving techniques, including Root Cause Analysis, to resolve unit operations and equipment issues.
- Respond to unit operations issues and equipment failures, document appropriately and ensure resolution of events through appropriate actions.
- Communicate effectively with others, especially team members, operations and crafts personnel.

**Maintain Qualified and Reliable State:**

- Evaluate all activities for impact on qualified state of unit operations/equipment and utilize appropriate business processes as necessary (change control etc).
- Responsible for system/component classification and maintenance strategy for equipment.
- Implement corrections, corrective actions, and countermeasures arising from investigations.
- Participate in Periodic Reviews for systems and equipment.
- Lead IQ/OQ/PQ activities (including commissioning activities of new unit operations/equipment)

**Asset Management:**

- Develop scope for capital projects targeted at both short- and longer-term needs. Act as user representative for local projects.
- Understand equipment reliability issues with the objective of improvement.
- Aid the coaching of operators and maintenance technicians in the effective use of equipment

**Improve Business:**

- Identify and drive improvement opportunities (procedural changes, upgrades, projects etc) associated with unit operations/equipment within the area.

**Basic Minimum Qualifications:**

- Bachelor’s Degree required. Degree in Engineering or related technical field preferred.
- Minimum of 5 years’ experience in Utility Engineering Teams, preferably in a manufacturing GMP 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:**

- Ability to build and maintain strong relationships with site stakeholders including site lead team, production, quality, safety and global engineering groups.
- Travel up to 10%. At times will travel offsite to other Lilly locations, other companies, conferences, off-site training or to support capital projects.
- Knowledge of one or more of the following areas; Clean Utilities, Black Utilities, HVAC, Electrical.
- Excellent communication skills

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

Senior Program Director - Virginia - GFD

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.

The Global Facilities Delivery (GFD) Organization, part of Corporate Engineering, delivers new and renovated capital assets around the world. Our mission is accomplished through a highly leveraged organization of design, construction, and qualification contractors. Many of the assets delivered focus on medical innovation and delivering innovative solutions to patients. Some of the assets delivered will expand the supply of existing medicines or strengthen the supply chain.

**Key Objectives/Deliverables**:

- Project Management: Lead and manage teams to deliver large programs of at least $1BN USD or more in capital assets that are highly business-critical in nature. These teams will consist of both Lilly and Non-Lilly professionals, working to safely achieve project objectives from front-end planning (conceptual design) in a Brownfield or Greenfield site through operational qualification (cradle to grave). Project objectives are defined as delivering asset capability or capacity with safety, cost, schedule, and quality assurance.
- Interface/Communication: Ability to lead from a regional distance from corporate headquarters while developing and maintaining effective communication with GFD leadership, the project team, governance teams, business partners, and other stakeholders. Facilitate issue resolution, anticipate scope changes, and implement project work safely with quality, speed, and value.
- Compliance: Lead with a disciplined, structured approach to project management based on compliance with Company Policies and Procedures.
- Safety/Environment: Develop and maintain safety and environmental execution plans for projects. Ensure compliance with safety and environmental policies, procedures, and work rules for project personnel, contractors, and subcontractors from conceptual design through operational verification.

**Minimum Requirements:**

- Bachelor of Science in Engineering or a technical related field (i.e. project management).
- Minimum of 15+ years previous experience in capital project delivery in industrial or manufacturing facilities (preferably leading projects/multiple projects \>$100MM in size).
- Previous experience managing greenfield projects.
- Willingness to relocate and/or travel to locations outside of home state/country.

**Additional Preferences:**

- Pharmaceutical manufacturing experience.
- Capital Project Management Experience in pharmaceutical manufacturing facilities such as: Bulk API, sterile products, secondary packaging, devices, and to a lesser extent, lab projects.
- Experience in the following areas: GMP manufacturing, LEAN, automation, construction, construction quality, project controls, the engineering disciplines, safety, and scheduling.
- The capacity to achieve results and influence through people.
- Demonstrated ability to work from long distances with little supervision.
- Must exhibit a good sense of judgment in decision making, without the need for management approval, while at the same time keeping management informed and engaged on critical issues.
- Effective communication skills, both written and verbal.
- Ability to influence personnel and organizations without having direct administrative responsibility for them.
- Competency in a foreign language(s).
- Professional Engineer (PE) or equivalent technical certification.
- Project Management Professional (PMP) certification.
- Experience in working and/or living outside the U.S.
- Demonstrated willingness to embrace the concept of continuous improvement and be an agent for change.

**Additional Information:**

- International travel is likely in this role and may include weekends and multi-week stays (15% to 30% travel, domestic and international).
- The position will require full relocation to the project location at a later date, as it does require onsite presence.
- This requisition is part of an Ai Candidate Skills Matching Pilot, Candidates dispositioned as “RESUME NOT REVIEWED” have not been reviewed by a human, however AI has been used to prioritize candidates for review based on how closely their skillset matches up to the skills needed for the role.

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

$159,000 - $233,200

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

Principal Associate - HSE

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

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

**Position Overview:**

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

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

**Responsibilities**:

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

**Basic Requirements:**

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

**Additional Skills/Preferences:**

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

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<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

Engineering Technician – Day Shift

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.

**Engineering Technician – Day Shift**

**Organization Overview:**

**At Lilly**, we unite caring with discovery to make life better for people around the world. Headquartered in Indianapolis, Indiana, we are a global leader in healthcare, committed to discovering life-changing medicines, advancing disease management, and supporting our communities through philanthropy and volunteerism. We put people first and strive to make a meaningful impact every day.

**Position Summary:**

The Engineering Technician at our Concord, NC facility plays a key role in supporting Parenteral Operations, our customer, by ensuring the efficient setup and operation of Pre-Filled Syringe and Isolator Equipment. This position requires hands-on engineering maintenance expertise to assist with equipment setup, operational support, troubleshooting, repairs, and ongoing maintenance.

The ideal candidate will demonstrate a strong understanding of customer needs, collaborate effectively with internal teams, and provide responsive, courteous support. Success in this role requires technical proficiency, problem-solving skills, and a commitment to delivering excellent customer service in a dynamic manufacturing environment.

**Key Responsibilities**

- Promote a safety-first, quality-always culture in all tasks and interactions
- Improve equipment uptime, line efficiency, and overall equipment effectiveness (OEE)
- Perform condition monitoring, troubleshooting, and provide operational support
- Diagnose and repair precision filling equipment with strong mechanical aptitude
- Collaborate with engineering and production teams to resolve equipment issues promptly
- Assist with equipment setup and changeovers to support production needs
- Adhere to all GMP and quality standards
- Must have the ability to quickly and accurately diagnose the root cause of a problem and properly implement corrective actions to minimize downtime
- Accurately document maintenance activities and corrective actions
- Support cross-functional tasks and assist outside primary responsibilities as needed
- Work independently and manage priorities under pressure

**Minimum Requirements:**

- High School / GED minimum
- Visa Sponsorship: 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.

**Basic Requirements**

- High school diploma or GED
- Minimum of 5 years’ experience in production maintenance
- 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**

- Strong mechanical aptitude and hands-on technical skills
- Proficient with basic hand tools
- Detail-oriented with a commitment to quality and precision
- Familiarity with safety protocols and proper PPE usage
- Physically able to stand for extended periods
- Effective team player with strong interpersonal skills
- Associate’s degree or technical certification in a related field is a plus
- Knowledge of FDA and GMP regulations
- Experience operating high-speed, automated production equipment, preferably Syringe/Vial Filling systems utilizing Isolator technology
- Ability to quickly learn and apply new procedures
- Experience working in a classified manufacturing environment
- Familiarity with Computerized Maintenance Management Systems (CMMS) platforms
- Strong verbal and written communication skills
- Customer-oriented mindset with a proactive approach
- Analytical thinker with strong problem-solving abilities

**Additional Information**

- Flexibility to work overtime or adjust schedule based on production demands
- Following a Monday–Friday, 8-hour training period, the role transitions to a 12-hour 2-2-3-day shift schedule
- Willing and able to respond to off-hour emergencies as needed
- Open to travel for training and professional development opportunities

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

$21.27 - $41.25

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

North Carolina

Tris Pharma

Packaging Mechanic

**Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned U.S. biopharmaceutical company** with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have \>150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

**Our science and technology make us unique, but our team members set us apart**; they are the engine fueling Tris’ passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company’s success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success.

Our Packaging Department is growing, and we have openings for Mechanics at various levels requiring various levels of experience. Title and salary commensurate with experience. **The Packaging Department works 10-hour days, Monday-Thursday, in our Monmouth Junction, NJ** **facility. Current open positions are for 1st & 2nd shifts.**

**Hours are (1st shift) 5:00 AM - 3:00 PM & (2nd shift) 3:00 PM – 1:00 AM**

The Packaging Mechanic is responsible for supporting and assisting the Packaging Department in ensuring efficient packaging of goods by performing packaging equipment maintenance including, but not limited to: troubleshooting, repair, upgrade, preventive maintenance (PM), etc. on various types of packaging equipment including, but not limited to: fillers, cappers, labelers, cartoners, bundlers, shrink wrappers, etc. in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) requirements.

**Essential Functions & Responsibilities:**

- Responsible for all aspects of Packaging equipment maintenance in accordance with company policies, SOPs, cGMPs and FDA requirements
- Performs packaging line change overs and startups
- Assists Packaging Operations/Quality Assurance (QA) activity during the running of packaging lines
- Performs routine and complex work related to the troubleshooting, repair, and upgrade of all packaging equipment including but not limited to: fillers, cappers, labelers, cartoners, bundlers, shrink wrappers, etc.
- Responsible for performing PM, repair and continuous improvement of packaging equipment
- Assists in performing root cause analysis on equipment failures to support investigations
- Ensures packaging equipment is operating safely at all times

Requirements

**REQUIREMENTS:**

**Minimum education and years of relevant work experience required:**

**Mechanic I:**  High School diploma or equivalent and minimum **3 years** packaging mechanic experience in the pharmaceutical or biotechnology industry.

**Mechanic II:**  High School diploma or equivalent and minimum **5 years** packaging mechanic experience in the pharmaceutical or biotechnology industry.

**Special knowledge or skills needed and/or licenses or certificates required:**

- Working knowledge of manufacturing procedures and federal regulations pertaining to manufacturing processes
- Working knowledge of good manufacturing systems and familiarity with regulatory and manufacturing SOPs and cGMPs
- Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc.
- Hands on experience with repair, maintenance and troubleshooting of pharmaceutical packaging equipment (i.e., fillers, cappers, labelers, cartoners, bundlers, shrink wrappers, etc.)
- Basic PC skills
- Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
- Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
- Planning, organization and time management skills including the ability to support and prioritize multiple projects
- Fluent in English (verbal and written)
- Ability and willingness to work additional hours as required by business needs

**Special knowledge or skills needed and/or licenses or certificates preferred:**

Trade school or certification

**Physical requirements:**

Manufacturing based position

Ability to lift up to 50 lbs

Ability to use Personal Protective Equipment (PPE)

Ability to stand for extended periods

Anticipated salary range: $73,000 – 85,000. Base salary to be offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.

New Jersey

Nurix Therapeutics

Director, IT Infrastructure & Operations

*Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.*

**About the role**

This is the operating leader for IT infrastructure and operations at Nurix, reporting to the SVP of Information Technology. You will own the function end to end: infrastructure, cybersecurity operations, end user services, and IT service management as one integrated scope. You partner with a fractional CISO on security strategy and policy while owning the operational execution. You work closely with the IT business partner leaders who own the application portfolios and partner directly with R&D and the broader scientific organization on their infrastructure needs.

You lead a team that spans enterprise architecture, system administration, and cybersecurity operations, with the service desk delivered through a mix of staff and managed service providers. You will manage both individual contributors and managers from day one. You set the standards and delegate delivery across this hybrid team of internal staff and managed service providers, empowering the people below you rather than running their queues, to support a fast-moving enterprise.

**What you'll do**

In your first year you will:

- Consolidate the managed service provider portfolio across infrastructure, security, and the help desk into a smaller, more accountable set of partners.
- Build a cybersecurity operations function from current contractor and MDR coverage.
- Establish a governance model with research and scientific computing, and bring research infrastructure into IT alignment. Working with the enterprise architect, inventory and remediate AWS systems: ParallelCluster and other HPC, container platforms (EKS, ECS), SageMaker, and identity bridges.
- Own a formal identity and access management program, including clean handoffs to IT operations and the business partner teams.
- Refresh the service experience end to end and raise vendor management discipline as scope grows.

**Requirements:**

- 12+ years of progressive technology services leadership, including 5+ years at the Director or Senior Director level.
- Direct experience leading multi-function technology services (infrastructure, cyber operations, and ITSM) as one integrated scope rather than separate towers.
- Comfort partnering with a CISO or fractional CISO on policy while owning operational execution. We are looking for an operator who builds security in partnership, not someone who pushes controls through operations.
- Deep experience across AWS plus the Microsoft Entra and Microsoft 365 stack.
- Familiarity with the infrastructure behind scientific and ML computing, AWS ParallelCluster and HPC, SageMaker, EKS and ECS, and DevOps and infrastructure-as-code practices, at a level sufficient to set standards and partner credibly with the scientific organization.
- A measurable track record managing a managed service provider portfolio, including real consolidation or vendor transitions with accountability for outcomes.
- Experience building out infrastructure in fast-moving, resource-constrained environments.
- Experience in a regulated industry (biotech, pharma, medical device, healthcare, financial services, or comparable).
- Bachelor's degree or equivalent practical experience.

**Nice to have**

- Biotech or pharmaceutical industry experience.
- Support for an FDA Pre-Approval Inspection or BIMO inspection in an IT or security capacity.
- Experience standing up a security operations function from contractor or MSP coverage.
- Partnership with a separate scientific computing organization (informatics, bioinformatics, cheminformatics, machine learning).
- Hands-on with an MDR provider such as RedCanary, Kroll, or Arctic Wolf.
- Jira Service Management or ServiceNow at scale.
- Public company SOX IT general controls experience.

Fit with Nurix Culture and Values

- Strong team orientation; highly collaborative
- Ability to function in a dynamic environment
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view

Salary Range: $ 260K – $300K plus bonus and equity

Location: Brisbane, CA - Onsite

Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy ([https://www.nurixtx.com/privacy-policy/)](<https://www.nurixtx.com/privacy-policy/)>).

California

Senior Manager, External Quality-Supply Chain

*Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.*

**About the Position:**

The Senior Manager, Supply Chain Quality Assurance is responsible for ensuring the quality and compliance of materials, products, and distribution activities throughout the global supply chain. This position provides quality oversight of contract manufacturers, suppliers, warehouses, packaging operations, depots and logistics providers to ensure compliance with applicable GMP, GDP, GCP (where applicable) and company quality standards.

This role partners with Supply Chain, Manufacturing, Regulatory Affairs, Technical Operations, Clinical, CMC, and external business partners ensuring the quality, compliance, and timely supply of clinical materials across Nurix’s pipeline programs.

Reporting to the Senior Director, Quality Assurance, the Senior Manager will apply sound independent judgment to drive timely identification, investigation, and resolution of quality events, while building a culture of continuous improvement and cross-functional collaboration.

**Responsibilities:**

- Provide Quality oversight of global supply chain operations supporting early and late-stage clinical programs.
- Ensure quality requirements are incorporated into procurement, manufacturing, packaging, storage, transportation and distribution activities.
- Oversee quality aspects of warehousing and distribution operations.
- Qualify, monitor, and maintain approval status of suppliers, CMOs, laboratories depots and logistics providers.
- Participate in supplier audits and quality risk assessments.
- Manager supplier quality agreements and ensure periodic review.
- Ensure compliance with Good Distribution Practices.
- Oversee qualification of shipping lanes and transportation providers.
- Review shipping validation documentation.
- Assess quality impact of shipping deviations through the review of shipping deviations, including review of temperature excursion investigations and product impact assessments.
- Identify continuous improvement opportunities to simply quality processes while maintaining compliance.
- Maintain current knowledge of evolving regulatory expectations and industry standards; translate requirements into practical operational guidance for the organization.

**Required Qualifications:**

- Bachelor’s degree in chemistry, pharmaceutical sciences, life sciences, engineering or a related
- 5+ years of progressive Supply Chain or Supply Chain Quality Assurance experience in the pharmaceutical or biopharmaceutical industry with global distribution activities.
- Demonstrated experience managing and directing activities of outsourced manufacturing, testing, packaging and labeling and distribution operations.
- Thorough knowledge of FDA regulations (21 CFR Parts 210/211) and ICH guidelines (Q7, Q8, Q9, Q10, Q11), and EudraLex - Volume 4 - Good Manufacturing Practice (GMP) and their practical application to CMC development.
- Proven track record managing quality events, deviations, CAPA programs, and change control in a clinical or commercial pharmaceutical setting.
- Experience supporting regulatory agency inspections (FDA, EMA, or equivalent).
- Excellent project management skills with the ability to manage multiple high-priority deliverables simultaneously.
- Strong verbal and written communication skills; able to present complex quality and compliance topics clearly to diverse stakeholders.
- Willingness to travel to CDMO and laboratory sites domestically and internationally, as

**Preferred Qualifications:**

- Experience in a clinical-stage biotech environment scaling quality operations through late-stage development and toward commercialization.
- Experience with electronic QMS platforms (e.g., Veeva Vault) and document management
- Expertise in both development-phase and pre-commercial-phase quality assurance standards and expectations.

**Salary:** $173,000 - $199,00

**Fit with Nurix Culture and Values**

- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view

Director, Drug Safety

**Director, Drug Safety**

*Join Nurix’s pharmacovigilance team to help ensure patient safety across our clinical pipeline of targeted protein degradation therapies. As Director, Drug Safety, you’ll lead aggregate safety analysis, benefit–risk assessments, and safety strategy for assigned programs — shaping how we evaluate risk and bring new medicines safely to patients. It’s a chance to influence critical safety decisions at the intersection of clinical medicine, data, and drug development.*

**The Opportunity**

**Medical Safety Leadership**

- Serve as the medical safety lead for assigned products, providing clinical and pharmacovigilance expertise to safety strategy and activities
- Lead aggregate safety data analysis for signal detection, signal evaluation, and risk characterization
- Conduct medical review and interpretation of safety data, contributing to benefit–risk assessments
- Monitor emerging safety signals and proactively address potential safety risks through appropriate internal and external communication

**Regulatory and Safety Documentation**

- Oversee medical review of Individual Case Safety Reports (ICSRs)
- Author and review regulatory safety documents, including Development Safety Update Reports (DSURs) and safety sections of INDs and regulatory briefing books
- Contribute to safety responses to regulatory authorities and participate in regulatory interactions
- Provide clinical leadership during inspections and audits related to safety and risk management

**Clinical Development Support**

- Provide clinical input into safety aspects of clinical trial protocols, informed consent forms, and investigator brochures
- Collaborate with clinical development, regulatory affairs, medical affairs, and other stakeholders to ensure a consistent global safety strategy

**Governance and Cross-Functional Collaboration**

- Serve on safety governance committees, supporting strategic decision-making for risk mitigation and benefit–risk evaluation

**What You’ll Bring**

- Advanced clinical or scientific degree, such as MD, DO, PharmD, or equivalent relevant training and experience
- Clinical experience preferred
- 5–10 years of experience in pharmacovigilance/drug safety within the pharmaceutical or biotechnology industry
- Experience supporting early clinical development and small biotechnology companies
- Demonstrated expertise in aggregate safety analysis and benefit–risk evaluation
- Strong knowledge of global pharmacovigilance regulations and guidance (ICH, FDA, EMA, MHRA)
- Experience interacting with global health authorities on safety matters
- Familiarity with signal detection and safety surveillance tools and databases
- Strong communication, collaboration, and cross-functional leadership skills
- Ability to interpret complex clinical and safety data and translate insights into regulatory and business strategy
- Ability to work effectively and collaboratively in a fast-paced, growing organization across functional boundaries

**Salary Range:**  Non-MD $247,300 - $280,400 | MD $295,000 - $317,100

*The posted range applies to roles based in the San Francisco Bay Area and reflects local market conditions. Where an offer lands within that range depends on the candidate’s relevant experience, technical expertise, and how their background aligns with the role’s requirements.*

**Location:** Onsite – Brisbane, CA

**Fit with Nurix Culture and Values**

- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view

**About Nurix Therapeutics**

*Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.*

Director, Nonclinical Toxicology Operations

**Director, Nonclinical Toxicology Operations**

*Nurix Therapetics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.*

**Position Summary:**

Nurix Therapeutics is seeking a Director of Preclinical Safety and Toxicology Operations to drive planning and execution of nonclinical safety and toxicology activities within our Research and Early Development division. The role will be responsible for operations activities including owning timelines, budgets, contracts, and cross-functional coordination for a portfolio of targeted protein degradation programs. The ideal candidate will be adept at partnering closely with subject matter experts, preclinical Project Leads, clinical Asset Team Leaders, and the SVP of Preclinical Toxicology who will provide oversight and scientific direction.

The role has two complementary halves. The first is operational support to the nonclinical Safety and Toxicology function — helping study directors and toxicology leads scope and design studies, selecting and managing CROs, negotiating and administering contracts, and keeping study execution on schedule and on budget. The second is program-level project management for drug discovery projects as they transition from late lead optimization through IND filing, integrating chemistry, DMPK, pharmacology, safety, CMC, and regulatory timelines into a single credible plan.

You will thrive here if you are highly organized, scientifically fluent, comfortable holding teams and stakeholders to a schedule, and energized by turning complex, interdependent work into clear milestones and decisions.

**Key Responsibilities**:

**Toxicology study support and vendor management**

- Partner with Toxicology Leads and Study Directors to scope, design, and schedule GLP and non-GLP in vivo and in vitro safety studies, including exploratory tox, DRF, GLP repeat-dose toxicology, safety pharmacology, and genetic toxicology.
- Identify, qualify, and manage CROs and specialty vendors; coordinate bid solicitation, bid defense, and vendor selection in partnership with Toxicology, Procurement, and Legal.
- Own the contract lifecycle: draft and route work orders, MSAs, change orders, and amendments; track scope changes against budget; reconcile invoices and support accruals and forecasting.
- Build and maintain integrated study timelines; monitor study milestones, sample logistics, bioanalytical turnaround, and report delivery, escalating slippage early with options rather than surprises.
- Coordinate protocol and report review cycles, ensuring documents move efficiently through internal review, QA, and sign-off.
- Track deliverables required for regulatory submissions, including study reports, certificates of analysis, and test article documentation.
- Demonstrated ability to ensure safety issues are communicated rapidly and with appropriate escalation to the drug safety/project team, leadership and relevant agencies.

**Program management, late lead optimization to IND**

- Serve as project manager for assigned discovery and development programs from late lead optimization through candidate selection, IND-enabling studies, and IND filing.
- Develop and maintain integrated program plans, critical paths, and resource views spanning medicinal chemistry, analytical chemistry, computational chemistry, DMPK, pharmacology, toxicology, CMC, and regulatory.
- Run project team meetings: set agendas, capture actions and decision rationale in meeting minutes, and follow through to closure.
- Maintain program dashboards, milestone trackers, and risk registers; surface risks with mitigation and contingency plans.
- Prepare materials and pre-reads for portfolio reviews, governance meetings, and leadership updates; ensure a single, consistent version of program status.
- Coordinate scenario and what-if planning to support go/no-go decisions, candidate selection, and IND timing.

**Cross-functional leadership and process**

- Act as a connective hub across functions and sites, resolving interface issues before they become timeline issues.
- Contribute to continuous improvement of project management practices, templates, and tools within the group.

**Qualifications:**

**Education**

- Required: M.S. or Ph.D. in a life sciences discipline (toxicology, pharmacology, biology, chemistry, pharmaceutical sciences, or related).
- Preferred: formal project management credential such as PMP.

**Experience**

- Typically, 10+ years of relevant biotech or pharmaceutical experience, including demonstrable project management ownership of multidisciplinary programs.
- Track record managing CROs and external vendors, including contracting, budget tracking, and performance management.
- Direct experience supporting and coordinating IND-enabling activities
- Working knowledge of small molecule drug discovery and development, nonclinical safety assessment, and GLP requirements, with scientific fluency sufficient to plan, question, and integrate the work.
- Experience in targeted protein degradation, oncology, or immunology is an advantage.

**Skills and attributes**

- Proficiency with project management tools and methods, including integrated timelines, critical path analysis, and resource planning (e.g., MS Project, Smartsheet, Planisware, or equivalent). Familiarity with AI tools a plus.
- Exceptional organizational skills and attention to detail, with the judgment to know what matters and what does not.
- Clear, concise written and verbal communication; able to present status and risk to senior leadership without embellishment.
- Ability to influence and drive accountability without direct authority across a group of senior, highly experienced scientists.
- Comfort with ambiguity and shifting priorities in a fast-moving discovery environment.

**Reporting and Location**

- Reporting to SVP of Nonclinical Toxicology, Based at Nurix Therapeutics, Brisbane, CA, with on-site presence expected to support close partnership with laboratory and program teams.

**Fit with Nurix Culture and Values**

- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view

**Salary Range:** $220,700 - $252,667

**Location:**  Brisbane, CA - Onsite

Insmed Incorporated

Manager, Upstream Pilot Plant

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Manager, Upstream Pilot Plant on the Manufacturing team to help us expand what’s possible for patients with serious diseases. Reporting to the Associate Director, Manufacturing, you’ll play an essential role in the successful production of high-quality Gene Therapy products. Your responsibilities will span a variety of activities, including upstream process execution (cell culture and bioreactor operations), maintaining GLP-compliant documentation, operating and maintaining cell culture equipment, authoring records and procedures, and contributing to continuous improvement initiatives within viral vector manufacturing.

**What You'll Do:**

In this role, you’ll have the opportunity to execute upstream processes, including cell culture expansion, bioreactor operations (bench, pilot, and production scales), and media/buffer preparation. You’ll also:

- Operate and maintain upstream bioprocessing equipment such as wave/rocking platforms, stirred-tank bioreactors, incubators, and automated control systems.
- Prepare, sterilize, and manage cell culture consumables while ensuring aseptic technique in all operations.
- Maintain strict adherence to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
- Prepare, review, and maintain batch records, SOPs, logbooks, raw material specifications, technology transfer documents, and campaign summary reports.
- Ensure compliance with company SOPs, training requirements, and best practices for scale-up and technology transfer.
- Maintain facility readiness and support inspections through vigilant oversight of upstream operations.
- Utilize Quality Systems and Enterprise Resource Planning (ERP) tools to record and track production activities.
- Provide upstream process subject matter expertise and take ownership of assigned deliverables.
- Demonstrate strong technical writing and communication skills.
- Always maintain a safe working environment and remain current with assigned training.

**Who You Are:**

You have a bachelor’s degree in Biology, Chemical Engineering or Biochemistry along with 5 years of experience in in upstream process development or manufacturing support in bioprocessing.

You are or you also have:

- Hands-on experience with mammalian or microbial cell culture, seed train expansion, bioreactor operations (bench, pilot, or production scale), and media/buffer preparation.
- Knowledge and application of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
- Proven ability to collaborate effectively within cross-functional teams in a manufacturing or development environment.
- Experience supporting manufacturing investigations, root cause analysis, and deviation resolution in biologics production.
- Familiarity with Quality Systems, Enterprise Resource Planning (ERP) platforms, and electronic documentation systems.

**Nice to have (but not required):**

- Preferred: Experience conducting manufacturing investigations in biologics or cell culture based production.

**Where You’ll Work**

This role is based out of our San Diego, CA office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.

**Travel Requirements**

Minimal travel expected

\#LI-BA

\#LI-ONSITE

**Pay Range:**

$124,000.00-161,000.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Senior Director, Engineering - Advanced Therapies

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:**

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy in Lebanon, Indiana. This facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety, quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to start up the facility for both clinical and commercial supply.

The Senior Director of Engineering is directly responsible for managing the site engineering function and ensuring it has the necessary capacity, capability and leadership structures in place to deliver the site engineering deliverables in support of the manufacturing plan. They provide administrative and technical leadership for the site engineering function including process engineering, process automation, maintenance, utilities, plant and project engineering, and engineering competencies.

They are a member of the Lilly Lebanon Advanced Therapies Site Lead Team and report directly to the Site Head. The Lead Team has collective responsibility to develop and implement the strategic direction, organizational capability and management of the site. Primarily, the members of the team drive the site toward achieving long term business objectives; they continuously develop the business and the organization for the future bearing in mind corporate objectives and the continuously changing external environment; and they manage issues that span multiple teams in the organization and extend into the broader corporate/external context.

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

**Startup Phase:**

- Be a collaborative, inclusive, energetic leader and support the broader lead team to:
- Build the organization with the necessary capability, capacity and culture to operate this facility to the highest standards of safety, quality, and operational excellence.
- Defines the site engineering priorities & roadmap in order to develop and implement the systems and processes needed to run the site. This includes leveraging existing Lilly knowledge where necessary, but also incorporating external experiences and learning.
- Serve as a key member of the site HSE Lead Team, ensuring safety focus throughout project delivery and startup.
- Support the project team to deliver the facility as the end user. Providing feedback and support on design decisions, commissioning strategies, startup plan, etc. Collaborate to ensure the right decisions are made to meet project deliverables and longer term strategic goals for the site.
- Develop and adapt organizational structure to provide correct and capable resources and management to deliver the site to a full scale GMP manufacturing scale.
- Ensure the systems are in place and executed to establish the initial qualified and safe state for equipment, processes, utilities and facilities
- Build technical relationships with the relevant corporate departments and sponsors strategic corporate initiatives at a site level.

**Post Startup:**

- Continue to define and support the site engineering priorities & roadmap; integrate the functional agenda with site priorities.
- Ensure the site is in compliance with corporate standards and policies for the engineering function, including applicable environmental, safety, and quality requirements.
- Have external focus, benchmark best practices across network and externally
- Ensure equipment, processes, utilities and facilities remain and operate in a qualified and safe state; Ensure that equipment maintenance and utilities operation are performed and documented to the highest standards of safety and quality.
- Manage the site investment processes for assets (planning, prioritization, resourcing, project management, capital accounting and reporting). Own the development and delivery of the capital investment plan in accordance with the site objectives for new products, recapitalization of assets, and facility modernization.
- Ensure that a robust control system exists to manage the business, identify compliance issues and escalate issues appropriately is established and maintained.
- Develop the future management and technical leadership for the site and for potential global assignments.

**Minimum Requirements:**

- Minimum of a Bachelor's degree (or equivalent) in a relevant Engineering discipline
- 10+ years of experience in a leadership role managing operations within the pharmaceutical industry, with specific knowledge and understanding of cGMPs and how they apply to manufacturing operations.
- Direct experience in Drug Substance or Drug Product manufacturing.

**Preferences:**

- Must have a strong ability to form effective relationships at all levels. This candidate must be able to work closely with the Site Leadership team to ensure alignment with corporate objectives and internal decision making processes, and be able to connect and communicate effectively with all levels of the organization on site.
- Should have a demonstrated track record of successfully developing, managing and executing projects from start to finish on time and within budget with high performance standards that ensure customer satisfaction.
- Should have experience developing and managing extremely talented, engaged and high performing teams with a focus on building strong team cultures to ensure a safe and successful work environment.
- Experience with manufacturing of advanced therapies (Biotech, Cell and/or Gene Therapy) is preferred.

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

$168,000 - $246,400

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

Sr. Advisor - Global Technical Services Molecule Steward - Dry Products

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.

**We are seeking talent at the Sr. Principal Scientist through Sr. Advisor level; the final title and scope will be aligned with the candidate’s experience, organizational impact, and leadership capabilities.**

**Key Objectives/Deliverables**

- Serve as Manufacturing TS/MS (Technical Services/Manufacturing Science) representative to integrate the commercialization work plans across Product Development, CM&C teams, Manufacturing sites, and applicable functional areas to commercialize new solid oral dosage forms.
- Leverage prior commercial manufacturing and development experience of solid oral dosage forms to anticipate commercial manufacturing challenges for new oral products. Work across Development and Manufacturing site(s) to implement appropriate product control strategies based on anticipated needs.
- Ensure that experiments and technical work plans are well designed and appropriately rigorous. Use first principles and theoretical knowledge to define scientific approaches to support technical expectations. Utilize in depth understanding of materials, process, and product to improve product/process robustness, reduce variability, and provide improvement or advanced application of control strategies across sites and technologies.
- Serve as the Global Molecule Steward for select solid oral dosage form drug products. Collaboratively integrate different disciplines such as engineering and analytical science on technical projects, process performance improvements, or control strategy effectiveness. Provide proficient data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs.
- Achieve network level results for Lilly's dry products (solid oral dosage forms) that improve the effectiveness of TS/MS, Lilly Manufacturing, or other parts of the business. Influence global leadership to drive improvements and resolve issues.
- Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites as well as additional technical support/guidance for external manufacturing as needed. Drive appropriate shared learning, alignment and improvement across manufacturing sites according to best practices and technical principles.
- Collaborate with Project Managers on key product project plans and support timely delivery of milestones with appropriate risk mitigation strategies.
- Leverage prior experience and knowledge as a recognized Subject Matter Expert to collaborate with Development and manufacturing sites in the optimization of key manufacturing platforms including continuous manufacturing. Influence Development strategies for new product or platform topics in line with Manufacturing needs. Identify and lead the deployment of new technologies as appropriate.
- Author technical reports and appropriate sections of regulatory submission and responses as needed. Prepare technical aspects of other Regulatory/Quality based documents and support Regulatory reviews and inspections as needed.
- Remain current on external pharmaceutical manufacturing trends and innovations. Leverage these to improve strategies and applications for developing and controlling manufacturing processes.
- Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation. As a reviewer of technical reports, provide input on the experimental findings and conclusions.
- Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors.

**Basic Requirements:**

- BS, MS, and/or PhD in Chemistry, Engineering, Pharmaceutical Science, or related science.
- Minimum 7-10 years of direct experience in **Oral Solid Dose Form Manufacturing and Development/Commercialization.**
- A minimum of 3 years of commercial manufacturing support (post process validation) of solid oral dosage forms with ability to apply this experience to development of new solid oral dosage form products.
- Evidence of technical expertise across multiple areas, unit operations, and platforms related to dry products (oral solid dosage forms) development, commercialization, and commercial GMP manufacturing.

**Preferred Qualifications:**

- Demonstrated, strong analytical and problem-solving abilities. Effective at integrating multiple technology disciplines to drive programs forward.
- Demonstrated, strong technical leadership and communication skills. Communicates effectively across disciplines and types of audiences (internal and external) to influence and/or drive common understanding and appropriate actions.
- Ability to work well independently, as well as in teams. Provides partnership and collaboration across multiple disciplines.

**Additional Preferences:**

- Flexibility to travel and interact with multiple partners/functions, regions, and cultures.
- Ability to lead cross functional teams effectively. Ability to work independently, and within teams. Provides partnership and collaboration across multiple disciplines.
- Demonstrated, strong analytical and problem-solving abilities.
- Effective at integrating multiple technology disciplines to drive programs forward.

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

$117,000 - $209,000

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

Associate VP for Dry Products/Spray Dried Dispersions

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.

As the Associate VP for Dry Products/SDD, you will provide scientific and organizational leadership for one of the fastest growing portions of Eli Lilly & Co’s portfolio. You will ensure the organization provides the technical product stewardship through hiring, developing, and retaining strong talent with the right technical capabilities. Success will require strong collaboration and partnership with key stakeholders such as Product Development, Manufacturing sites, Network scientific resources, and other functional areas to ensure alignment and prioritization of the organization’s key deliverables and technical agenda.

**Key Responsibilities/Deliverables:**

**Build and run the organization**

- Determine the appropriate technical expertise that should exist at a Network level, and work to close capability gaps through hiring, development, and retention of technical talent.

- Ensure that resources are deployed effectively to deliver timely and rigorous support to the dry product sites.

- Oversee the performance management process for the organization and ensure all employees have development plans in place to elevate performance and support career goals.

- Conduct interim and end of year performance reviews

- Coach, develop, and provide feedback to reports

- Lead recognition, compensation, and promotion activities

- Lead talent assessment and succession planning for network and site TS/MS organizations

- Encourage shared learning within and outside the department

- Lead short and long-term business planning (objectives, budget, capital, capability)

**Lead control strategy, commercialization, and tech agenda**

- Work with leadership of TS/MS, PR&D, Quality, Engineering, and Operations to develop the expectations for Control Strategy Implementation.

- Work with PR&D to ensure that control strategies for new products are robust.

- Actively work with Dry product sites to install processes with robust validations.

- Develop a strong working relationship with Development to support new products commercialization.

- Ensure

- Build and scale up/pilot plant capability vital to support the network tech agenda through the development of technical talent, pilot plant infrastructure/capital, and ensuring all individuals have adequate training.

**Ensure TS/MS** **Functional Excellence at Manufacturing Sites**.

- Ensure that we build functionally excellent TS/MS groups at each manufacturing site within the network.

- Coach and mentor the TS/MS heads at the Dry products manufacturing sites.

- Ensure that there are appropriately trained individuals, adequate recruiting, and adequate succession planning at the sites.

- Become the point of contact for critical manufacturing issues and ensure appropriate escalation of significant issues. Consult on deviations, process changes, and validations.

**Foster a culture of safety & compliance**

- Ensure personal and team compliance with all applicable regulatory and corporate policy requirements

- Ensure appropriate safety practices and procedures are in place and are followed to prevent injuries;

- Ensure that Dry products/SDD meets current Quality expectations and is a part of actively monitoring evolving Quality and other regulatory expectations related to dry products manufacturing.

**Basic Qualifications:**

- BS in pharmaceutical sciences, pharmacy, engineering, Chemistry, or a related field. Masters or PHD preferred

- 15+ years experience in Pharmaceutical Manufacturing, Technical Services, Product development with a minimum of 4 years previous supervisory experience.

**Additional Skills/ Preferences:**

- Understanding of cGMPs in a manufacturing setting.

- Outstanding written and oral communication skills.

- Knowledge of corporate policies.

- Ability to influence without direct authority.

- Experience in technical leadership positions in Dry Product manufacturing

- Strong leadership and written and oral communication skills

- Effective interpersonal skills

- Demonstrated problem solving abilities.

- Recognized as knowledgeable on oral solid dosage form and dry product technologies

- Effective at integrating multiple technology disciplines to drive programs forward.

- Partnership and collaboration across multiple disciplines

**Additional Information:**

**Environmental and Working Conditions (Personal Considerations)**

- Occasional access to manufacturing/processing areas where there may be gases, noise, dust, chemicals, solvents, grease, inflammables, and machine in movement.

**Tools, Machines, Equipment, Materials**

- Occasionally may use personal protection equipment such as safety shoes, laboratory coats, gloves, hardhat, and any other equipment as needed.

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

$241,500 - $354,200

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

Engineering Associate Director (AD) - Device Assembly

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:**

Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $3 billion to create a new state-of-the-art manufacturing site, in Kenosha, Wisconsin. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Kenosha County site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don’t want to miss!

**Position Brand Description:**

The Engineering Associate Director (AD)- Device Assembly is responsible for the staffing, training, and leadership of the engineering group (both process, automation and maintenance) supporting asset delivery, process development, commissioning, qualification, validation and startup of the packaging lines in the site expansion project. After startup, the Engineering AD will be responsible for supporting the day-to-day engineering activities as well as planning for the 3 - 6-month horizon. The Engineering AD is expected to lead by example and provide coaching to others in the areas of safety, quality, engineering, optimization and continuous improvement.

**Key Objectives/Deliverables:**

**Manage for Results /Strategic Planning:**

- Manage Engineering and Maintenance support for Commercial Manufacturing Operations:
- Manage team of process and automation engineers and maintenance technicians providing Front Line support in one or more of the following areas:
- Parenteral Operations (Parts Washers, Autoclaves, Formulation, Isolator – Syringe Filler, Automated Visual Inspection)
- Device Assembly
- Packaging Operations
- Warehouse and Logistics (Autonomous Guided Vehicles, Automatic Storage and Retrieval System, etc.)
- Site Utilities (HVAC, Steam Water, Gases, etc.), BMS, Chambers (i.e. Refrigerators, Incubators, Cold Rooms, etc.)
- Ensure appropriate technical and maintenance support for manufacturing or utilities processes of the assigned area.
- Guide SMEs that will provide coaching/assistance to Front Line Engineers and drive increased equipment reliability and uptime, continuous improvements, support capital delivery, among other key strategic initiatives.
- Understand, ensure and decision making based on engineering standards and policies, procedures and business plan that impact the ability of the team members to meet performance objectives.
- Provide Functional Leadership to engineering and maintenance representatives by coaching the following business processes: Change Management, Deviations/Investigations, Equipment and Process Improvements, Process Controls and Variability Reduction
- Lead, support and peer review root cause analysis around equipment and operational events, support complex change controls and quality investigations with strong Root Cause analysis focus.
- Prioritize teams work to optimize equipment output and impact, ensuring proactive and continuous improvement mindset for process and operational improvements and optimization.
- Apply statistical thinking and data analysis methods to understand process variability and capability to drive improvements.
- Support regulatory inspections.
- Utilize control systems to monitor, trend and verify equipment performance and downtime. Identify and Optimize unit operation cycle time, yield performance, loop tuning, recipes, etc.
- Support or lead troubleshooting efforts to resolve equipment and operational problems and ensure formal problem-solving techniques are appropriately utilized. On call/off hours support required.
- Understand and ensure compliance with environment health & safety requirements.
- Present and attend various Governance teams to represent engineering.
- Represent group as technical SMEs on capital projects supporting/leading design, modifications, testing, qualifications, and associated documentation.
- Support commissioning and qualification activities.

**Leadership**

- This position involves direct management of front-line & SME engineering and maintenance team members.
- Provide leadership, training, development, coaching and support of engineering team members.
- Engage and promote use of internal and external networks and partnerships to help deliver sound technical decisions.
- Promote use of first principals with engineering staff and drive engineering solutions for problems.
- Monitor and ensure compliance with quality requirements. (trainings, CAPA, deviations)

**Basic Requirements:**

- Bachelor's degree in engineering
- At least 7 years process engineering experience

**Additional Preferences:**

- Previous management or leadership experience including leading or working effectively with a cross functional group
- Strong experience in equipment optimization, reliability and troubleshooting
- Strong technical aptitude and ability to train and mentor others
- Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA.
- Previous experience with highly automated equipment.
- Previous experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment.
- Previous facility or area start up experience.
- Previous equipment qualification and process validation experience.
- Previous experience with Manufacturing Execution Systems and electronic batch release.
- Previous experience with Automated Storage and Retrieval System (ASRS) Warehouses or AGVs.
- Previous experience with deviation and change management systems including Trackwise.

**Other Information:**

- Up to 20% travel and more can be expected during the startup phase.
- Required to be on call, as applicable.
- Shift work may apply.

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 - $198,000

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

Wisconsin

Principal Engineer – TSMS Packaging

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:**

The TSMS Packaging Principal Engineer is a technical position that provides technical oversight and leadership for packaging materials, equipment, and operations at the Lilly Kenosha County (LKC) site. As LKC is a greenfield site, this role will be foundational in standing up the packaging technical program — from equipment and packaging line design input, through tech transfer and process validation (PV), to sustaining commercial support. Upon the start of commercial production, the role's objectives shift to maintaining the validated state of applicable processes, monitoring metrics to ensure a state of control and capability, harmonizing control strategies across process teams, driving continuous improvement, and serving as an escalation point for day-to-day packaging operations issues.

Primary objectives include the start-up and compliant manufacturing of LKC products, including implementation of the packaging process control and validation strategy. The Packaging Engineer is responsible for providing technical support for the processes, materials, systems, and equipment associated with packaging. The scope of the role includes packaging for products transferred to and/or launched at the LKC site.

While this role is not expected to be the technical expert on all products and platforms, it is expected to be the site expert in the regulatory, internal, and other requirements governing packaging. A key part of this role is ensuring consistency in approach and process across the product lifecycle — from tech transfer through regulatory submission and into routine manufacturing — and in aligning LKC's technical approach with sister DAP sites as the network matures. The role also develops and implements a technical agenda and serves as a mentor within the TSMS team, engaging in upstream and external-to-site activities related to packaging.

**Key Objectives/Deliverables:**

- Understand the scientific principles required for packaging combination drug products, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
- Serve as a technical SME during the design, build, and commissioning phases at a greenfield site, providing manufacturing science input into packaging line, equipment, and material design to support future tech transfer and validation.
- Own the technical agenda for the LKC Packaging TSMS program.
- Provide technical oversight for packaging materials, including serving as site lead for printed packaging materials and serialization as the program matures.
- Provide packaging technical support to operations with respect to materials, equipment, and processes.
- Lead technical evaluations and problem resolution, including troubleshooting and root cause analysis.
- Lead risk assessments of packaging operations and packaging material suppliers.
- Provide technical support for all start-up activities (e.g., tech transfer, equipment/process qualification, process validation) ahead of and through PV.
- Provide technical support for non-routine investigations (e.g., deviations, complaints), including consultation on quality and stability.
- Prepare, review, approve, and provide technical support for relevant technical documents, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, PFMEAs, VMPs, APRs, Process Monitoring, and specifications.
- Ensure an accurate instruction set (tickets & procedures) describes the process as performed and the control strategy for discrete manufacturing steps.
- Lead risk management activities pertaining to assigned products and processes.
- Develop, monitor, and appropriately react to statistically based metrics in real time to assess process variability and capability.
- Identify opportunities and lead TSMS technical projects to ensure a successful site start-up and improve process control, yield, product quality, and/or productivity; implement process changes and improvements through the technical agenda.
- Serve as a technical interface with upstream suppliers, equipment vendors, and the global packaging network, including sister-site DAP teams, to drive technical consistency across the network.
- Serve as a technical mentor for TSMS engineers, scientists, and other disciplines.
- Represent the LKC TSMS team for internal and external communications, including with suppliers.
- Provide audit and regulatory inspection (including PAI) support, as needed.
- Work within and lead cross-functional teams in a positive manner to implement TSMS objectives and deliver on business plan and quality objectives.
- Ensure a safe working environment through compliance with safety rules and by actively participating in safety-related activities, helping to establish a strong safety culture from site start-up.

**Basic Qualifications:**

- Bachelor's degree or higher in engineering, science, or a related field.
- Engineering experience in plant, process, project delivery, maintenance, or related fields supporting packaging operations.
- Minimum of 5 years of experience in a manufacturing organization (or other related experience).
- Experience supporting cGMP manufacturing operations.
- Strong interpersonal and teamwork skills.
- Strong self-management and organizational skills, with the ability to operate with a high degree of autonomy in a start-up environment.
- Oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization.
- 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:**

- MS in packaging engineering.
- Understanding of packaging specifications, qualification processes, product/package stability, and packaging components.
- Experience with vendor management, including selection and qualification.
- Familiarity with technology advances in packaging, including serialization.
- Technical transfer experience, including equipment qualification and process validation.
- Experience supporting or standing up a new site, line, or greenfield facility.
- Root cause investigation experieince
- Demonstrated successful leadership of cross-functional teams.
- Previous experience with deviation and change management systems.
- Proficiency with computer systems including Microsoft Office products, Veeva Vault, electronic batch records, and SAP.

**Additional Information:**

- Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required.
- Some travel may be required to other manufacturing sites and Lilly’s corporate office

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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

$67,500 - $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

Senior Program Director - Huntsville - GFD

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 Global Facilities Delivery (GFD) Organization, part of Corporate Engineering, delivers new and renovated capital assets around the world. Our mission is accomplished through a highly leveraged organization of design, construction, and qualification contractors. Many of the assets delivered focus on medical innovation and delivering innovative solutions to patients. Some of the assets delivered will expand the supply of existing medicines or strengthen the supply chain.

**Key Objectives/Deliverables:**

- Project Management: Lead and manage teams to deliver large programs of at least $1BN USD or more in capital assets that are highly business-critical in nature. These teams will consist of both Lilly and Non-Lilly professionals, working to safely achieve project objectives from front-end planning (conceptual design) in a Brownfield or Greenfield site through operational qualification (cradle to grave). Project objectives are defined as delivering asset capability or capacity with safety, cost, schedule, and quality assurance.
- Interface/Communication: Ability to lead from a regional distance from corporate headquarters while developing and maintaining effective communication with GFD leadership, the project team, governance teams, business partners, and other stakeholders. Facilitate issue resolution, anticipate scope changes, and implement project work safely with quality, speed, and value.
- Compliance: Lead with a disciplined, structured approach to project management based on compliance with Company Policies and Procedures.
- Safety/Environment: Develop and maintain safety and environmental execution plans for projects. Ensure compliance with safety and environmental policies, procedures, and work rules for project personnel, contractors, and subcontractors from conceptual design through operational verification.

**Minimum Requirements:**

- Bachelor of Science in Engineering or a technical related field (i.e. project management).
- Minimum of 15+ years previous experience in capital project delivery in industrial or manufacturing facilities (preferably leading projects/multiple projects \>$100MM in size).
- Previous experience managing greenfield projects.
- Willingness to relocate and/or travel to locations outside of home state/country.

**Additional Preferences:**

- Pharmaceutical manufacturing experience.
- Capital Project Management Experience in pharmaceutical manufacturing facilities such as: Bulk API, sterile products, secondary packaging, devices, and to a lesser extent, lab projects.
- Experience in the following areas: GMP manufacturing, LEAN, automation, construction, construction quality, project controls, the engineering disciplines, safety, and scheduling.
- The capacity to achieve results and influence through people.
- Demonstrated ability to work from long distances with little supervision.
- Must exhibit a good sense of judgment in decision making, without the need for management approval, while at the same time keeping management informed and engaged on critical issues.
- Effective communication skills, both written and verbal.
- Ability to influence personnel and organizations without having direct administrative responsibility for them.
- Competency in a foreign language(s).
- Professional Engineer (PE) or equivalent technical certification.
- Project Management Professional (PMP) certification.
- Experience in working and/or living outside the U.S.
- Demonstrated willingness to embrace the concept of continuous improvement and be an agent for change.

**Additional Information:**

- International travel is likely in this role and may include weekends and multi-week stays (15% to 30% travel, domestic and international).
- The position will require full relocation to the project location at a later date, as it does require onsite presence.
- This requisition is part of an Ai Candidate Skills Matching Pilot, Candidates dispositioned as “RESUME NOT REVIEWED” have not been reviewed by a human, however AI has been used to prioritize candidates for review based on how closely their skillset matches up to the skills needed for the role.

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

$159,000 - $255,200

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

Alabama

MES 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.

**MES Engineer**

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 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.

Lilly is investing $6.5 billion to build a new state-of-the-art active pharmaceutical ingredient (API) manufacturing site at Generation Park in Houston, Texas. The new site will produce APIs for small-molecule medicines for cardiometabolic health and will be built with the latest high-tech equipment, highly integrated and automated manufacturing systems, and a focus on minimizing environmental impact. This is a once-in-a-lifetime opportunity to help build and start up a new site.

**What You'll Be Doing**

The MES Engineer is part of the new API facility's MES team, supporting the design, development, delivery, and computer system validation of DeltaV MES solution. You will implement, configure, and support the MES solution to meet the site's operational, quality, and compliance needs — working closely with Operations, Tech Services, Engineering, Quality, and the broader Tech at Lilly team to ensure successful deployment and long-term support of MES capabilities.

**Your Primary Responsibilities**

- Partner with site teams to gather requirements, define digital workflows, and author/validate electronic batch records aligned with operational processes.
- Support MES startup activities, including configuration of MES recipes, workflows, electronic work instructions, and electronic batch records (EBRs).
- Configuration of electronic logbooks (Equipment Tracking) and Weigh & Dispense
- Configuration of MES interfaces with other manufacturing systems (ERP system, Historian, DCS, Manufacturing Equipment via Edge technology, etc)
- Implement and support site-level testing and validation efforts (e.g., Installation Qualification, Performance Qualification) to ensure system readiness.
- Generation of associated CSV (Computer System Validation) documentation
- Troubleshoot MES issues and collaborate with multi-functional teams to resolve system or process gaps.
- Support site readiness and go-live efforts, including hypercare support and frontline troubleshooting.
- Ensure compliance with Lilly Global Standard Operating Procedures (GSOPs) and Computer System Validation (CSV) standards, including 21 CFR Part 11 and GAMP 5.
- Develop and maintain system documentation, SOPs, training materials, and support guides
- Collaborate with global/site MES architects and platform teams to align on standards, design, and configuration best practices.

**What You Should Bring**

- Pharmaceutical Manufacturing Regulatory compliance knowledge and experience (cGMP)
- Experience with DeltaV MES (Previously known as Syncade) Recipe Authoring and validating Master Batch Records (MBRs) in a regulated environment.
- Strong analytical and problem-solving skills across applications, configurations, and integrations.
- Excellent communication skills, with the ability to articulate complex technical concepts to non-technical audiences.
- Ability to work closely with Operations, Quality, Engineering, and IT teams to translate operational needs into executable MES solutions.
- Experience with tier-one MES platforms, in particular Emerson Syncade/DeltaV.

**Your Basic Qualifications**

- Bachelor’s Degree in IT, Engineering, or related technical field,
- 5+ years experience with MES system design, implementation, and validation.
- 3+ years of experience in regulated pharmaceutical or medical device manufacturing environments.
- 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**

- Prior experience with no-code/low-code frontline platforms, in particular Tulip, and with distributed control systems such as Emerson DeltaV, including recipe and batch interfaces to MES.
- Strong documentation skills and attention to detail, with experience in generating validation deliverables and training materials.
- Professional experience working in a GxP regulated environment.
- Experience commissioning and qualifying systems at a new site, and supporting API, small molecule, oligonucleotide, or synthetic chemistry operations.

**Other Information**

- Role is based onsite at Houston, Texas – API Manufacturing Site

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 - $158,400

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

Texas

Advisor - Program Manager - GFD

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 Global Facilities Delivery (GFD) Organization, part of Corporate Engineering, delivers new and renovated capital assets around the world. Our mission is accomplished through a highly leveraged organization of design, construction, and qualification contractors. Many of the assets delivered focus on medical innovation and delivering innovative solutions to patients. Some of the assets delivered will expand the supply of existing medicines or strengthen the supply chain.

**Key Objectives/Deliverables:**

- Project Management: Lead and manage teams to deliver large programs of at least $500MM USD or more in capital assets that are highly business-critical in nature. These teams will consist of both Lilly and Non-Lilly professionals, working to safely achieve project objectives from front-end planning (conceptual design) in a Brownfield or Greenfield site through operational qualification (cradle to grave). Project objectives are defined as delivering asset capability or capacity with safety, cost, schedule, and quality assurance.
- Interface/Communication: Ability to lead from a regional distance from corporate headquarters while developing and maintaining effective communication with GFD leadership, the project team, governance teams, business partners, and other stakeholders. Facilitate issue resolution, anticipate scope changes, and implement project work safely with quality, speed, and value.
- Compliance: Lead with a disciplined, structured approach to project management based on compliance with Company Policies and Procedures.
- Safety/Environment: Develop and maintain safety and environmental execution plans for projects. Ensure compliance with safety and environmental policies, procedures, and work rules for project personnel, contractors, and subcontractors from conceptual design through operational verification.

**Minimum Requirements:**

- Bachelor of Science in Engineering or a technical related field (i.e. project management, construction management).
- Minimum of 10+ years previous experience in capital project delivery in industrial or manufacturing facilities (preferably leading projects/multiple projects \>$100MM in size).
- Previous experience managing greenfield projects.

**Additional Preferences:**

- Pharmaceutical manufacturing experience
- Capital Project Management Experience in pharmaceutical manufacturing facilities such as: Bulk API, sterile products, secondary packaging, devices, and to a lesser extent, lab projects
- Experience in the following areas: GMP manufacturing, LEAN, automation, construction, construction quality, CQV (commissioning, qualification, and validation), project controls, the engineering disciplines, safety, and scheduling
- The capacity to achieve results and influence through people
- Demonstrated ability to manage interface risk and scope boundaries across multiple design/construction contractors on a single program
- Demonstrated ability to work from long distances with little supervision (ability to make decisions without managerial approval while keeping management informed/engaged on critical issues)
- Effective communication skills, both written and verbal
- Ability to influence personnel and organizations without having direct administrative responsibility for them
- Competency in a foreign language(s)
- Professional Engineer (PE) or equivalent technical certification
- Project Management Professional (PMP) certification
- Experience in working and/or living outside the U.S.
- Willingness to relocate and/or travel to locations outside of home state/country.
- Demonstrated willingness to embrace the concept of continuous improvement and be an agent for change

**Additional Information:**

- International travel is likely required in this role and may include weekends and multi-week stays (15% to 30% travel, domestic and international).
- The position will require full relocation to the project location in Houston, TX for the duration of the project. Onsite presence required (this is NOT a remote role).

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

$129,000 - $209,000

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