69 Eli Lilly jobs in the United States

Drug Development Project Manager - Boston

19424 Oak Ridge, Pennsylvania ICON Clinical Research

Posted 2 days ago

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Drug Development Project Manager - Boston
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
The Drug Development Project Manager (Senior Drug Development Director) oversees the high-level plans and progress of these teams, managing projects from pre-clinical stages through to commercialization. The DDPM is responsible for incorporating overarching indication activities and milestones, documenting their downstream impact, and justifying changes in project budget and resources. This role involves close collaboration with the Asset Strategy Lead and function leads within the EDST or AST. The DDPM compiles and owns the integrated cross-functional project plan, ensuring alignment with corporate strategy.
As part of the Project Management Office (PMO), DDPMs advocate for project management techniques and processes, coaching team members on consistent utilization, including risk mapping, mitigation strategies, and logging lessons learned.
**What you will be doing:**
+ When in a managerial role, the DDPM supports the development of team members, enhancing their confidence, skills, and experiences in alignment with corporate strategy while ensuring the team adheres to agreed project scopes.
+ Establishes a project lifetime plan with appropriate detail, proactively identifying risks and resolving issues.
+ Maintains and communicates project timelines, budgets, and resource allocations, flagging delays and discrepancies while liaising with governance, finance, and function heads.
+ Fosters high team performance by proactively engaging stakeholders and partnering with project leadership to ensure effective governance meetings.
+ Collaborates with various teams and function leads to translate strategies into integrated project plans, taking ownership of these plans and sharing insights that influence project direction.
+ Encourages positive team dynamics, working with HR to organize team-building activities and ensuring secure document sharing among team members and stakeholders.
+ Communicates any significant project accelerations or delays to leadership, driving corrective actions as needed.
+ Partners with internal and external stakeholders to establish effective project communications and manage changes towards common goals while promoting conflict resolution.
+ Develops and implements methods and frameworks for quality decision-making to support operational excellence in drug development projects and process improvement initiatives.
+ Collaborates with finance to address budget-related inquiries, conduct baseline comparisons, and perform variance analysis, optimizing internal project templates.
+ Co-creates dashboards with business process managers and acts as a liaison to identify reporting needs from business partners.
**You are:**
+ Strong leadership skills, promoting values that enhance team dynamics.
+ Excellent communication skills, fostering inclusivity and collaboration.
+ Proven interpersonal skills for conflict mediation and management.
+ Solid project management skills with broad exposure to the pharmaceutical R&D process; advanced planning experience with MS Project is essential. PMP certification is a plus.
+ Adaptability to continuous change.
+ Proficient verbal and written English communication skills (full professional proficiency required).
+ Advanced degree (Master's or PhD) in a health-related discipline or equivalent experience.
+ Minimum of 10 years of experience in drug development across various phases and disease areas.
+ At least 5 years of program management experience in a pharmaceutical or biotech setting, preferably in cross-cultural environments.
+ Genuine interest and some experience in people management.
+ Experience in Regulatory Affairs and/or Clinical Development is an advantage.
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
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Senior Formulation Scientist, Drug Development

97201 Portland, Oregon $120000 Annually WhatJobs

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full-time
Our client, a leading pharmaceutical innovator, is seeking a highly skilled Senior Formulation Scientist to join their state-of-the-art R&D facility in **Portland, Oregon, US**. This role is crucial for the development of novel drug delivery systems and the optimization of existing pharmaceutical formulations. The successful candidate will lead formulation development projects, from pre-clinical stages through to clinical manufacturing, ensuring the safety, efficacy, and stability of investigational drugs.

Key responsibilities include designing and executing formulation studies, investigating different excipients and drug delivery technologies, and performing characterization of drug products. You will analyze experimental data, interpret results, and provide scientifically sound recommendations for formulation strategies. The Senior Formulation Scientist will collaborate closely with analytical development, process development, and regulatory affairs teams to ensure seamless project progression. A deep understanding of pharmaceutics, solid dosage forms, parenteral formulations, or other relevant drug delivery systems is essential. The ideal candidate possesses excellent problem-solving skills, meticulous attention to detail, and strong experimental design capabilities. Experience with various analytical techniques (e.g., HPLC, dissolution testing, particle size analysis) is required. We are looking for a proactive and innovative scientist dedicated to advancing pharmaceutical science and contributing to the development of life-changing medicines in the **Portland, Oregon, US** area.

Qualifications:
  • Ph.D. or Master's degree in Pharmaceutics, Chemistry, Chemical Engineering, or a related field.
  • Minimum of 5-7 years of experience in pharmaceutical formulation development.
  • Strong knowledge of solid dosage forms (tablets, capsules) or parenteral formulations.
  • Experience with various drug delivery technologies and excipient selection.
  • Proficiency with common analytical techniques for drug product characterization.
  • Experience in Good Manufacturing Practices (GMP) environments.
  • Excellent data analysis, report writing, and presentation skills.
  • Ability to work independently and lead projects within a multidisciplinary team.
  • Familiarity with regulatory guidelines for drug development is beneficial.
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Senior Formulation Scientist - Drug Development

43210 Dublin, Ohio $120000 Annually WhatJobs

Posted 4 days ago

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full-time
A prominent pharmaceutical company is seeking a highly skilled Senior Formulation Scientist to join their drug development team in **Columbus, Ohio, US**. This critical role involves the design, development, and optimization of novel drug formulations to enhance bioavailability, stability, and patient compliance. You will be a key contributor to the pharmaceutical product lifecycle, from early-stage research through to clinical trial support and process scale-up. The successful candidate will leverage their expertise in pharmaceutical sciences to overcome complex formulation challenges and ensure the successful translation of drug candidates into viable medicinal products.

Responsibilities include conducting pre-formulation studies, selecting appropriate excipients, developing various dosage forms (e.g., tablets, capsules, injectables, topical preparations), and performing in vitro characterization and performance testing. You will be responsible for designing and executing stability studies, analyzing data, and generating comprehensive reports. The Senior Formulation Scientist will also collaborate closely with analytical development, manufacturing, and regulatory affairs teams to ensure successful project progression. Expertise in solid-state characterization techniques (e.g., XRD, DSC, TGA) and dissolution testing is essential. Experience with spray drying, hot melt extrusion, or other advanced formulation technologies would be a significant asset. Mentoring junior scientists and contributing to the development of best practices within the formulation department are also key aspects of this role.

We are looking for candidates with a Master's or Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline, coupled with a minimum of 5 years of relevant industry experience in pharmaceutical formulation development. Proven experience in guiding formulation projects from concept to completion is required. A strong understanding of GMP regulations and ICH guidelines is mandatory. Excellent analytical, problem-solving, and project management skills are essential, as are strong written and verbal communication abilities. This position is based at our state-of-the-art research facility in **Columbus, Ohio, US**, and requires full-time, in-person commitment.
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Senior Formulation Scientist - Drug Development

76102 Fort Worth, Texas $115000 Annually WhatJobs

Posted 4 days ago

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full-time
Our client, a dynamic biopharmaceutical company, is seeking an experienced Senior Formulation Scientist to lead innovative drug development efforts at their state-of-the-art facility in Fort Worth, Texas, US . This on-site role is crucial for advancing our client's pipeline of novel therapeutics. The Senior Formulation Scientist will be responsible for the design, development, and optimization of stable, effective, and scalable drug delivery systems. You will leverage your expertise in pharmaceutics to create formulations for various dosage forms, including oral solid dosage forms, injectables, and topical preparations. Key responsibilities include conducting pre-formulation studies, selecting appropriate excipients, developing manufacturing processes, and performing stability testing according to ICH guidelines. You will work collaboratively with analytical development, process engineering, and CMC teams to ensure seamless transitions from lab-scale development to pilot and commercial manufacturing. The ideal candidate possesses a strong understanding of physical chemistry, material science, and drug delivery principles. You will be expected to troubleshoot formulation challenges, interpret experimental data, and author comprehensive technical reports and regulatory submission documents. This position requires a proactive individual with excellent problem-solving skills and a proven ability to manage multiple projects simultaneously. A commitment to scientific rigor, attention to detail, and effective communication are essential for success. We are looking for a creative thinker who can contribute novel approaches to complex formulation problems and drive projects from concept to completion.

Responsibilities:
  • Design and develop novel pharmaceutical formulations for various dosage forms.
  • Conduct pre-formulation studies, including solubility, compatibility, and stability assessments.
  • Select and characterize appropriate excipients to achieve desired drug product performance.
  • Optimize formulation processes and parameters for robustness and scalability.
  • Perform stability studies under various conditions and interpret results.
  • Develop and validate analytical methods for formulation characterization.
  • Troubleshoot formulation and process-related issues.
  • Author technical reports, development summaries, and regulatory documents.
  • Collaborate effectively with cross-functional R&D and CMC teams.
  • Stay abreast of industry trends and advancements in drug delivery technologies.
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Senior Formulation Scientist, Drug Development

32801 Orlando, Florida $130000 Annually WhatJobs

Posted 4 days ago

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full-time
Our client, a cutting-edge pharmaceutical company, is seeking an accomplished Senior Formulation Scientist to join their innovative Drug Development department in Orlando, Florida, US . This pivotal role will focus on the design, development, and optimization of pharmaceutical formulations for novel drug candidates. You will lead formulation development activities, conduct pre-formulation studies, and scale-up processes from laboratory to pilot production. The ideal candidate will possess extensive expertise in various dosage forms (e.g., oral solids, injectables, topical), a strong understanding of physical chemistry principles, and proficiency with analytical techniques for drug characterization. You will collaborate closely with cross-functional teams, including discovery, toxicology, CMC, and regulatory affairs, to advance drug candidates through the development pipeline. This hybrid role combines essential lab work with strategic remote planning and analysis.

Key Responsibilities:
  • Design and execute experiments for the development of stable, effective, and scalable pharmaceutical formulations.
  • Conduct pre-formulation studies, including solubility, stability, and compatibility assessments.
  • Develop and optimize manufacturing processes for various dosage forms.
  • Perform scale-up activities from benchtop to pilot and commercial scale.
  • Characterize drug substances and formulated products using appropriate analytical techniques (e.g., HPLC, dissolution testing, particle size analysis).
  • Write comprehensive development reports, protocols, and regulatory submission documents (e.g., IND, NDA).
  • Troubleshoot formulation and process-related issues.
  • Stay current with industry trends, regulatory guidelines (FDA, EMA), and emerging technologies in pharmaceutical formulation.
  • Collaborate effectively with internal departments (Discovery, CMC, Regulatory, Clinical) and external partners.
  • Manage projects, timelines, and resources for assigned formulation development activities.
  • Provide scientific guidance and mentorship to junior scientists and technicians.
  • Contribute to the intellectual property strategy through invention disclosures.

Qualifications:
  • Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field.
  • Minimum of 5-7 years of relevant experience in pharmaceutical formulation development.
  • Proven track record in developing various dosage forms, with specific expertise in (e.g., oral solid dosage forms, parenteral products).
  • Strong understanding of physical chemistry, polymer science, and drug delivery principles.
  • Proficiency with relevant analytical instrumentation and techniques.
  • Experience with process development and scale-up activities.
  • Familiarity with GMP requirements and regulatory submission processes.
  • Excellent problem-solving, experimental design, and data analysis skills.
  • Strong written and verbal communication skills, including technical report writing.
  • Ability to work independently and collaboratively in a dynamic research environment.
  • Experience with specific formulation technologies (e.g., hot melt extrusion, spray drying) is a plus.

This is a career-defining opportunity to contribute to the development of life-changing medicines. Join our client's dedicated team and make a significant impact in the pharmaceutical industry.
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Senior Formulation Scientist, Drug Development

55401 Minneapolis, Minnesota $135000 Annually WhatJobs

Posted 10 days ago

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full-time
Our client, a leading pharmaceutical company dedicated to improving patient lives, is seeking a highly skilled Senior Formulation Scientist to join their innovative drug development team. This role offers a hybrid work model, combining remote research and analysis with essential laboratory work and team collaboration on-site. You will be instrumental in designing and developing novel drug formulations, ensuring optimal stability, bioavailability, and efficacy. This position demands extensive knowledge of pharmaceutical sciences, formulation techniques, and regulatory guidelines.

Responsibilities:
  • Design and execute pre-formulation studies and develop stable, effective oral and parenteral dosage forms.
  • Characterize drug substances and excipients, evaluating their compatibility and impact on formulation performance.
  • Utilize laboratory equipment for formulation development, including mixers, granulators, tablet presses, and encapsulators.
  • Develop and validate analytical methods for assessing drug product quality attributes.
  • Conduct stability studies according to ICH guidelines and analyze results to inform formulation decisions.
  • Troubleshoot formulation challenges and optimize processes for manufacturing scale-up.
  • Prepare technical reports, protocols, and regulatory submission documents (e.g., IND, NDA sections).
  • Collaborate closely with analytical development, process development, and regulatory affairs teams.
  • Stay abreast of emerging technologies and scientific advancements in drug formulation and delivery.
  • Mentor junior scientists and contribute to the scientific growth of the team.
Qualifications:
  • Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemistry, or a related field.
  • Minimum of 7 years of experience in pharmaceutical formulation development, with a strong focus on solid dosage forms and/or injectable formulations.
  • Proven expertise in pre-formulation, formulation design, and characterization techniques.
  • Hands-on experience with various dosage form manufacturing processes and equipment.
  • Thorough understanding of GMP, ICH guidelines, and regulatory requirements for drug product development.
  • Proficiency in relevant analytical techniques (e.g., HPLC, dissolution testing, DSC, TGA).
  • Strong problem-solving skills and ability to work independently and collaboratively.
  • Excellent written and verbal communication skills.
  • Experience in data analysis and interpretation.
This hybrid role is based in Minneapolis, Minnesota, US , requiring a balance of remote and in-office presence. Make a significant impact on the future of medicine.
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Director of Biologics Drug Development

78201 San Antonio, Texas $180000 Annually WhatJobs

Posted 13 days ago

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full-time
Our client, a groundbreaking biopharmaceutical company, is actively seeking a distinguished Director of Biologics Drug Development to join their fully remote, high-caliber team. This senior leadership position is integral to advancing our client's innovative pipeline of biologic therapies from early-stage discovery through clinical development and regulatory submission. You will provide strategic leadership and scientific expertise in the development of complex protein-based therapeutics, guiding multidisciplinary teams to achieve critical milestones. Key responsibilities include designing and overseeing preclinical and early clinical development strategies, managing CMC (Chemistry, Manufacturing, and Controls) aspects for biologic products, and ensuring rigorous adherence to regulatory guidelines (FDA, EMA). The ideal candidate will possess an extensive understanding of protein biochemistry, molecular biology, bioprocessing, and immunogenicity assessment. You will collaborate closely with research scientists, translational medicine experts, clinical operations, and regulatory affairs to ensure seamless program progression. A Ph.D. in Biochemistry, Molecular Biology, Immunology, or a related life sciences discipline is mandatory, along with a minimum of 10-12 years of progressive experience in biologics drug development within the pharmaceutical or biotechnology industry. Demonstrated success in bringing biologic candidates through IND and early clinical phases is essential. Exceptional leadership, strategic thinking, and communication skills are required to effectively lead teams and interface with senior management and external partners. This is a unique opportunity to drive the development of life-changing medicines from a remote setting, contributing significantly to patient well-being and the advancement of scientific innovation.
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Senior Formulation Scientist - Drug Development

94105 San Francisco, California $145000 Annually WhatJobs

Posted 13 days ago

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full-time
Our client, a leading biopharmaceutical company, is seeking an innovative and experienced Senior Formulation Scientist to join their Drug Development division in San Francisco, California, US . This critical role will focus on the design, development, and optimization of novel drug formulations for both small molecule and biologic therapeutics. The ideal candidate will possess a deep understanding of pharmaceutical sciences, drug delivery systems, and analytical characterization techniques. This hybrid role allows for collaborative work in the lab and office, with the flexibility of remote work for certain responsibilities.

Responsibilities:
  • Lead the formulation development of new drug candidates from pre-clinical stages through to clinical development.
  • Design and execute experiments to evaluate and optimize drug product stability, bioavailability, and manufacturability.
  • Investigate and select appropriate excipients and delivery technologies to achieve desired pharmacokinetic profiles and therapeutic efficacy.
  • Perform characterization of drug substances and drug products using a variety of analytical techniques (e.g., HPLC, dissolution testing, particle size analysis, DSC, spectroscopy).
  • Develop and validate analytical methods for the assessment of formulation performance and quality.
  • Troubleshoot formulation-related issues and provide technical solutions to development challenges.
  • Prepare comprehensive technical reports, study protocols, and regulatory submission documents (e.g., IND, NDA).
  • Collaborate closely with discovery scientists, process development engineers, analytical chemists, and regulatory affairs teams.
  • Stay current with scientific literature, industry trends, and regulatory guidelines relevant to formulation development.
  • Mentor and guide junior scientists, fostering a collaborative and productive research environment.
  • Manage external contract research organizations (CROs) as needed for formulation development and testing.
Qualifications:
  • Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemistry, Chemical Engineering, or a related discipline.
  • Minimum of 6 years of progressive experience in pharmaceutical formulation development within the biotech or pharmaceutical industry.
  • Proven track record in developing formulations for oral solid dosage forms, injectables, or other relevant dosage routes.
  • Extensive experience with various analytical techniques used in pharmaceutical characterization and quality control.
  • Strong understanding of drug delivery principles, pharmacokinetics, and biopharmaceutics.
  • Experience with both small molecule and biologic formulations is highly desirable.
  • Proficiency in experimental design (DoE) and data analysis.
  • Excellent problem-solving skills and a detail-oriented approach.
  • Strong written and verbal communication skills, with the ability to present complex scientific information clearly.
  • Ability to work effectively independently and as part of a cross-functional team.
  • Familiarity with Good Manufacturing Practices (GMP) and regulatory requirements.
This position offers a competitive salary, comprehensive benefits, and the chance to contribute to the development of life-changing medicines at a leading biopharmaceutical company.
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Senior Formulation Scientist, Drug Development

78701 Austin, Texas $130000 Annually WhatJobs

Posted 20 days ago

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full-time
Our client, a leading pharmaceutical innovator, is seeking a highly skilled and experienced Senior Formulation Scientist to join their dynamic Drug Development team in Austin, Texas, US . This role is crucial in advancing our pipeline from pre-clinical to clinical stages, focusing on developing robust and scalable drug delivery systems. The ideal candidate will possess a deep understanding of pharmaceutics, solid dosage forms, and advanced drug delivery technologies. You will be responsible for designing, executing, and interpreting formulation development studies, troubleshooting technical challenges, and contributing to regulatory filings. This will involve extensive hands-on laboratory work, including pre-formulation characterization, excipient screening, prototype formulation development, process optimization, and stability testing. You will collaborate closely with cross-functional teams, including analytical chemistry, process development, and clinical operations, to ensure seamless project progression. Key responsibilities include developing formulations for oral solid dosage forms (tablets, capsules), evaluating drug solubility and stability, selecting appropriate excipients and manufacturing processes, and scaling up formulations from lab bench to pilot scale. A strong commitment to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) is essential. The successful candidate will also mentor junior scientists, contribute to intellectual property generation, and stay abreast of the latest scientific advancements in pharmaceutical formulation. A Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field, coupled with at least 5 years of relevant industry experience, is required. Excellent analytical, problem-solving, and communication skills are paramount for success in this challenging and rewarding position.
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Senior Formulation Scientist - Drug Development

27701 Durham, North Carolina $135000 Annually WhatJobs

Posted 21 days ago

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full-time
Our client, a leading pharmaceutical company dedicated to improving global health, is seeking an accomplished Senior Formulation Scientist to join their innovative research and development team. This is a vital, in-office position located in the heart of the thriving pharmaceutical hub of Durham, North Carolina, US . The Senior Formulation Scientist will be instrumental in the design, development, and optimization of novel drug delivery systems and dosage forms. You will leverage your extensive scientific expertise to guide projects from early-stage feasibility through to late-stage clinical development, ensuring the successful translation of promising drug candidates into safe and effective therapies.

Key Responsibilities:
  • Lead the formulation development of various dosage forms, including oral solid, liquid, semi-solid, and injectable products.
  • Design and execute experiments to investigate drug solubility, stability, bioavailability, and release profiles.
  • Utilize DoE (Design of Experiments) principles to optimize formulations and manufacturing processes.
  • Characterize drug products using a range of analytical techniques (e.g., HPLC, dissolution testing, DSC, XRD).
  • Develop and validate analytical methods for formulation testing and release testing.
  • Prepare comprehensive technical reports, development summaries, and regulatory submission documents.
  • Collaborate with cross-functional teams, including pre-clinical, clinical, analytical development, and manufacturing departments.
  • Troubleshoot formulation and process-related issues, proposing and implementing effective solutions.
  • Evaluate new excipients, technologies, and manufacturing processes relevant to drug formulation.
  • Mentor junior scientists and contribute to the growth and development of the formulation sciences team.
  • Stay current with regulatory guidelines (FDA, EMA) and industry best practices in pharmaceutical development.
The ideal candidate will possess a Master's or Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline, with a minimum of 5-7 years of experience in pharmaceutical formulation development. A deep understanding of physical pharmacy, drug delivery principles, and GMP (Good Manufacturing Practice) is essential. Proven experience with solid-state characterization and advanced analytical techniques is highly desirable. Excellent written and verbal communication skills, strong project management abilities, and a collaborative mindset are crucial for success in this role. This is a challenging and rewarding opportunity to contribute to the advancement of innovative medicines.
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