Eli Lilly and Company

Sr. Director - CMC Development


PayCompetitive
LocationPhiladelphia/Pennsylvania
Employment typeFull-Time

This job is now closed

  • Job Description

      Req#: R-39661

      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 35,000 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.

      Avid Radiopharmaceuticals, Inc. (Avid RP), a wholly-owned subsidiary of Eli Lilly and Company, is a molecular imaging company developing diagnostics and biomarkers that improve global health by accelerating the development of new medicines and enabling a tailored approach to healthcare.

      Responsibilities:

      This position has overall responsibility for Avid’s global investigational medicinal product (IMP) manufacturing, IMP and commercial product precursor contract manufacturing and provides leadership and direction to IMP Manufacturing Operations, and Supply Chain operations teams. The individual will provide expertise and leadership in the development and manufacturing of new radiopharmaceutical products working in a fast-paced, multi-disciplinary environment.

      • Lead and direct the establishment and operation of Avid’s just-in-time manufacturing of PET radiopharmaceutical investigational medicinal product (IMP) at contract manufacturing organizations (CMO) globally to ensure reliable and sufficient supply to Avid/Lilly clinical trials.
      • Provide leadership and direction to IMP Manufacturing Operationsand Supply Chain Operations functions and teams
      • Oversee the management of IMP and commercial product precursor and reference standard contract manufacturing to support global operations.
      • Oversee Supply Chain Operations supporting global IMPand Radiopharmaceutical Commercial Manufacturing
      • Partner with key functions (e.g. Clinical Supply, Clinical Development, Clinical Operations, and Clinical Imaging Operations) in the planning and execution of a manufacturing strategy to meet clinical trial supply requirements.
      • Assess and approve GMP change controls (globally) with respect to technical impact.
      • Direct planning for and monitoring of the CMC Development budget.
      • Lead other tasks / projects as assigned


      Basic Requirements:

      • Bachelor’s degree in Chemistry or related field
      • Minimum of 5 years of pharmaceutical industry experience


      Additional Skills/Preferences:

      • PET drug experience preferred
      • Ability to lead and direct teams of scientists and operational staff in the successful execution of complex drug development and supply projects and programs
      • Advanced understanding of cGMPs and CMC regulatory requirements
      • Ability to manage people and drive engagement among teams
      • Ability to adapt to change and be a nimble learner
      • Ability to ensure accountability of oneself and others
      • Ability to plan and align
      • Creative thinking and ability to cultivate innovation
      • Impeccable organizational skills
      • Superior written and verbal communication skills
      • Excellent computer skills (e.g. Word, Excel, PowerPoint, Teams)


      Additional Information:

      • Must be willing and able to travel within the USA and worldwide 20% of time.
      • Lilly currently anticipates that the base salary for this position could range from between $141,000 to $206,800 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. 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).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, 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.
      • Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

      Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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

      Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

      #WeAreLilly

  • About the company

      Eli Lilly and Company is an American pharmaceutical company headquartered in Indianapolis, Indiana, with offices in 18 countries.

Notice

Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000.

Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility.

An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report. NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000.