Lilly

Open roles (6)

Associate Director - TSMS Dry External Manufacturing

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: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Responsibilities The Associate Director - Technical Services/Manufacturing Science (TS/MS) Dry Products External Manufacturing (Dry EM) is responsible for managing the activities of TS/MS and ENG personnel supporting the oversight of external manufacture of dry products. The Assoc. Director TSMS must balance coaching a technical and engineering staff, prioritization and staffing for routine production support activities, implementation of technical projects, technical transfers, commercialization, process optimizations and engineering activities oversight. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation and engineering practices. The position requires working cross-functionally within sites, network, commercialization teams, and multiple global contract manufacturers to deliver on technical /engineering objectives, specific product business plan, and quality objectives. Key Objectives/Deliverables: Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc. Performance management and development of staff. Partner within TS/MS , ENG and across functional disciplines to influence and implement the technical agenda, site business plan objectives, functional objectives, and GMP Quality Plan objectives Ensure appropriate technical and Engineering oversight and stewardship of oral solid dose form manufacturing and packaging including drug product intermediates (e.g. spray dried dispersions/amorphous solid dispersions). Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits Define strategic direction and provide oversight for setting the technical agenda to improve process control, yield, and/or productivity for all products within the site portfolio. Ensure adequate oversight and technical excellence for investigations and complaints including CAPA and monitoring improvement. Ensure adequate oversight for technical projects/technical agenda to improve process control, capacity, yield, quality. Ensure adequate technical representation and engagement within site and network governance meetings to influence technical agendas. Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites. Build relationships external to Lilly to create benchmarks opportunities and identify best practices. Potential to engage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization. Escalate to Sr. Leaders in a timely fashion risks to supply, manufacturing issues major deviations, critical complaints or safety and cybersecurity issues. Lead implementation and execution of activities aligned with emerging need related to process improvement, control strategy or new regulation and ensure any emerging need is incorporated into the CMs technical agenda. General: Contribute to CM selection process by assessing capabilities of external companies and providing functional recommendations to sourcing options. Contribute to Business Plan and Strategic Plan processes Serve as cross-functional member on DryEM Lead Team Ensure JPT objectives and priorities are delivered and issues escalated. Support financial planning and reporting for Dry EM. Relationships: TS/MS, ENG functions at other Lilly locations (e.g. Lilly plant sites and central TS/MS). All relevant functions within external manufacturers. Internal Manufacturing Nodes (PR01, Alcobendas) Dry EM team. API-EM group. External Manufacturing Organizations. Lilly GQAAC Lilly Global Supply Chain functions. Lilly functions. Lilly Geneva and IHL Kinsale (If required) . Lilly External Manufacturing Support Teams Basic QualificationsBachelor s Degree in scientific disciplines of Chemistry, Biology, Biotechnology, Pharmacy, Engineering or another related field. 8+ years' experience in Dry Products/Oral Solid Dose pharmaceutical manufacturing environment in any of the following associated disciplines: TSMS, Production, Engineering at a manufacturing site . Previous leadership/people management experience. Additional Skills/ PreferencesAbility to represent Eli Lilly's mission, policies and practices in a positive, professional and ethical manner to influence CMs. Responsible for maintaining a safe work environment Ability to influence and inclusively lead diverse groups Influences complex regulatory/quality, business, or technical issues within the site and function Experience in statistics Technical leadership, administrative and organizational skills Builds relationships with internal and external customers and partners Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional Ability to manage/lead coordinate complex projects Strong analytical and quantitative problem-solving skills Ability to communicate and influence effectively across functional groups and stakeholders Strategic thinking and ability to balance short term needs with long term business evolution Enthusiasm for changes, team spirit and flexibility Demonstrated ability to learn & apply technical/scientific knowledge Capability to work in a virtual and complex environment Additional Information 20-30% travel may be required Some off-shift work (night/weekend) may be required to support 24/7 operations across global networks 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 ( ) 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 $123,000 - $180,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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about 14 hours ago

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Lilly

Director - TS/MS Dry Products Manufacturing and Commercialization

Indianapolis, Indiana, United States

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 Director/Sr. Director/Executive Director, TS/MS - Dry Products Network provides technical leadership for drug product manufacturing processes under development and in commercial production in the Dry Product Network. We are seeking talent at the Director through Executive Director 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 work across Product Development, CM&C teams, Manufacturing sites, and applicable functional areas to commercialize new dry oral solid drug products. Leverage prior commercial manufacturing and development experience of oral solid dose forms to anticipate commercial manufacturing challenges for new dry products. Work across Development and Manufacturing site(s) to implement appropriate product control strategies based on anticipated needs. Ensure that experiments and technical work 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 oral solid 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 (oral solid dosage forms) that improve effectiveness of TS/MS, Lilly Manufacturing, or other parts of the business by driving significant organizational improvement and capability work. 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 batch and continuous manufacturing operations. Influence Development on new product or platform topics in line with Manufacturing needs. Identify and lead the deployment of other new technology 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. Monitor and influence (as needed) 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, Pharmacy, or related science with minimum 18+ years of direct experience in Oral Solid Dose Form Manufacturing and Development/Commercialization. A minimum of 5 years of commercial manufacturing support (after process validation) of oral solid dose (OSD) forms with ability to apply this experience to development of new OSD products. Preferred Qualifications: Evidence of deep technical expertise in 1st principles (physics, engineering, chemistry/physical chemistry) across OSD unit operations and related subjects. Ability to apply these effectively in the development, technical transfer, scale up/down, and trouble shooting/optimization of OSD commercial manufacturing processes. Ability to lead implementation of new technologies and digital capabilities to optimize manufacturing capabilities. Evidence of technical leadership to develop and drive organizational/technical/compliance (Regulatory/Quality) strategies as well as contribute to organizational development through mentoring and coaching. Excellent written and oral communication skills with ability to influence Management and broader organization. Additional Preferences: Flexibility to interact with multiple partners/functions, regions, and cultures. Ability to work well independently, as well as in teams. Provides partnership and collaboration across multiple disciplines. Ability to lead teams effectively. 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 ( ) 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 $151,500 - $264,000 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.

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about 14 hours ago

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Lilly

Associate VP for Dry Products/Spray Dried Dispersions

Indianapolis, Indiana, United States

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 o th er 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 c ontrol 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 a nd 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; E nsure 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 D ry Product manufacturing Strong leadership and written and oral communication skills Effective interpersonal skills Demonstrated problem solving abilities. Rec ognized 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 g ases, 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 ( ) 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 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.

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about 14 hours ago

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Lilly

Associate Director - TS/MS - Advanced Therapies Manufacturing

Lebanon, Indiana, United States

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 a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is currently constructing a cutting edge manufacturing facility in Lebanon, Indiana, dedicated to the production of new modalities for Advanced Therapies. This site will be Lilly's most technically advanced manufacturing facility, purpose built to deliver the next wave of innovative medicines. The facility will leverage next generation manufacturing technologies and advanced data collection and analytics platforms to drive step change improvements in safety, quality, and process performance. This is a unique opportunity to join the team responsible for building a state of the art facility and technical system from the ground up. The successful candidate will play a key role in the design and startup of the site, supporting both clinical and commercial supply. The TS/MS organization will own end to end responsibility for technology transfer, process validation, and ongoing process stewardship. Position Description: The TS/MS Associate Director provides technical and people leadership across Drug Substance and Drug Product processes supporting cGMP late phase and commercial manufacturing for advanced therapies. This role balances day to day production support with delivery of technical projects and process improvements, ensuring strong prioritization, execution, and team performance. Key responsibilities include leading technology transfer of new modalities to the site; developing and executing process and validation strategies; establishing and maintaining robust process control and capability; and ensuring GMP compliance across all associated documentation and activities. The role requires deep knowledge of cGMPs, gene therapy platforms, global regulatory manufacturing expectations, and industry validation standards. The Associate Director partners closely with Engineering, Operations, Quality Assurance, Quality Control, Development, Central TS/MS, and Regulatory functions to drive the site's technical agenda in a highly cross functional environment. The position also interfaces with other Lilly manufacturing sites and external contract manufacturers. Key Objectives/Deliverables: Lead and promote a strong safety culture; ensure compliance with all corporate and site Health, Safety, and Environmental (HSE) requirements. Drive performance management, coaching, and development of TSMS staff to build a high performing technical organization. Demonstrated expertise and extensive experience in gene therapy processes, technologies, cGMP commercialization, and regulatory expectations. Provide technical oversight, review, and approval of GMP documentation, including investigations, deviations, change controls, validations, regulatory submissions, annual product reviews, batch records, procedures, control strategies, and technical studies. Partner cross functionally to define and execute the site technical agenda in alignment with business objectives and the GMP Quality Plan. Serve as a technical representative in regulatory interactions, audits, and engagements with external stakeholders. Set strategic technical direction to improve process control, robustness, yield, productivity, and overall manufacturing performance. Ensure strong technical governance and timely closure of investigations and product complaints. Oversee technical projects focused on improving process capability, capacity, quality, and team effectiveness. Represent the site within the manufacturing network to influence and align technical priorities. Drive global knowledge sharing and harmonization of best practices, scientific rationale, and control strategies. Support and lead technology transfer and commercialization of new molecule entities through close collaboration with Development and Central teams, and provide technical oversight of manufacturing activities at external manufacturing sites. Develop and implement site operating systems and processes, leveraging established Lilly practices while incorporating external best practices where appropriate. Basic Requirements: BS/MS in Biochemistry, Biotechnology, Biochemical engineering or related field. 5+ years of cGMP commercial manufacturing experience in TS/MS or associated disciplines such as Manufacturing, Quality Control, Quality Assurance, or Engineering. 3+ years of experience leading teams Additional Preferences: Experience supporting AAV and/or mRNA/LNP manufacturing in a GMP environment. Demonstrated technical leadership with strong administrative, organizational, and people management skills. Proven ability to deliver highly complex, cross functional work in fast paced or evolving manufacturing environments. Strong project management capability, including coordination of multi disciplinary technical projects. Excellent analytical, quantitative, and root cause problem solving skills. Effective communication and influencing skills, with the ability to engage stakeholders across functions and organizational levels. Strategic mindset with the ability to balance short term execution needs and long term business and technology evolution. Demonstrated ability to rapidly learn, apply, and translate technical and scientific knowledge into practical manufacturing solutions. 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 ( ) 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 $123,000 - $180,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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about 14 hours ago

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Lilly

Associate Director - Technical Services/Manufacturing Science (TSMS) - API External Manufacturing (Peptides)

Indianapolis, Indiana, United States

Posted

about 14 hours ago

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Lilly

Associate Director TSMS

Indianapolis, Indiana, United States

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 For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always. The Associate Director - Technical Services / Manufacturing Science (TSMS) - API is responsible for providing technical and people leadership across Active Pharmaceutical Ingredient (API) manufacturing processes supporting cGMP commercial and late-phase operations. This role oversees the full lifecycle of technical activities including technology transfer, process validation, manufacturing support, process optimization, and lifecycle management of API products. The Associate Director is expected to lead by example, coaching and developing a team of scientists and technical staff while driving a strong safety and quality culture. A key differentiator for this role is the ability to leverage data analytics and digitalization strategies to enhance process understanding, improve manufacturing performance, and advance site capabilities. This position requires close collaboration with Engineering, Operations, Quality Assurance, Quality Control, Regulatory Affairs, and Development functions to deliver on the site's technical agenda in a highly cross-functional environment. Responsibilities Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc. Hire, manage, mentor, and develop a team of scientists and technical staff, fostering a culture of excellence, accountability, and continuous learning. Partner within TSMS and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits Ensure adequate oversight and technical excellence for investigations and complaints. Ensure adequate oversight for technical projects to improve process control, capacity, yield, and quality. Ensure adequate technical representation and engagement within site and network governance meetings to influence technical agendas. Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites. Potential to engage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization. Champion the adoption and integration of data analytics platforms, statistical process control (SPC), and real-time monitoring tools to improve process performance and reduce variability. Partner with Digital/IT and Engineering functions to define and implement a site digitalization roadmap aligned with business and quality objectives. Drive digitalization initiatives including manufacturing execution systems (MES), d igital execution , data historians, and advanced analytics dashboards to enable data-driven decision-making. Basic Qualifications: B.S., M.S., or Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences. 6+ years (B.S./M.S.) or 5+ years (Ph.D.) of relevant cGMP commercial API manufacturing experience in TSMS or associated disciplines such as Manufacturing, Quality Assurance, Quality Control, Engineering, or Regulatory Sciences. Additional Preferences: Responsible for maintaining a safe work environment Ability to influence and lead diverse groups Influences complex regulatory, business, or technical issues within the site and function Hands-on experience with digitalization initiatives including MES implementation, data historian platforms (e.g., OSIsoft PI), digital execution platforms, or LIMS systems. Track record of leading or contributing to continuous improvement programs leveraging digital tools and data analytics. Technical leadership, administrative and organizational skills Builds relationships with internal and external customers and partners Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional Demonstrated Project Management skills and ability to coordinate complex projects Strong analytical and quantitative problem-solving skills Ability to communicate and influence effectively across functional groups and stakeholders Strategic thinking and ability to balance short term needs with long term business evolution Enthusiasm for changes, team spirit and flexibility Additional Information: Minimal travel ( Some off-shift work (night/weekend) may be required to support 24/7 operations 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 ( ) 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 $123,000 - $180,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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about 14 hours ago

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