• Job Description

  Req#: R-56086

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

  About Loxo@Lilly:

  Loxo@Lilly aims to create medicines that make life better for all those affected by cancer around the world. Bringing together the focus and spirit of a biotech with the scale, resources, and heritage of Lilly, our team is focused on rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating oncology medicines that unequivocally show early signs of clinical activity and will matter to patients. We intend to curate a balanced pipeline of medicines, either internally or externally discovered, with the potential to treat cancer with dramatic effect. Loxo@Lilly was created in December 2019, combining the Lilly Oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. Loxo@Lilly is a global organization with team members in Louisville, Colorado; Indianapolis, Indiana; New York City, New York; San Diego, California; South San Francisco, California; Stamford, Connecticut; and Madrid, Spain.

  The Associate Director, GMP Quality Assurance will work closely with Loxo Regulatory, Drug Supply, CMC, and the associated contract organizations in support of activities associated with large molecule GMP manufacturing and release of finished product. As needed, this individual will interface with and support Quality Systems.

  Responsibilities:

  Work closely with Loxo@Lilly QA, CMC, Regulatory, Drug Supply, and CMO colleagues through all phases of drug development, particularly early phase to ensure compliance and timeliness of GMP work, including:

  • Batch record review (Executed and Master) for all stages of large molecule manufacturing (biological intermediates, drug substance, conjugates, drug product, packaging and labeling)

  • Final disposition of finished product for clinical use, including country-specific release and collaboration with Qualified Persons (QPs)

  • Authoring and review of deviations, CAPAs, and change controls

  • Investigation of product complaints

  • Quality review of analytical documentation including: analytical methods; validation protocols and reports; specifications; and stability protocols, reports, and expiry extensions

  • QC of IMPD/IND CMC sections

  • Review and approval of clinical product labels

  • Authoring/ revision of SOPs

  • Leading process improvements

  • Ensuring that GMP work at Loxo @Lilly and contract organizations is done in compliance with applicable laws, regulations, guidelines, and SOPs.

  • Participation on project teams and sub-teams as needed and assigned

  • Additional tasks as required.

  Required Qualifications:

  • A minimum of BA/BS in science or engineering

  • A minimum of 8 years of experience in an FDA regulated Biotech or Pharmaceutical setting with a focus on large molecule drug development

  Additional Preferences:

  • Strong scientific/technical understanding of large molecule drug development and manufacturing

  • Experience in Batch Review and Release for clinical phase products

  • Experience authoring and reviewing Deviations, CAPAs, and Change Controls

  • Working knowledge of cGMP’s (CFR/ICH) and applicable international regulations/guidelines

  • Experience working with Contract Manufacturing Organizations

  • Strong understanding of GMP requirements for early phase large molecule drug development

  • Attention to detail and accuracy of work

  • Ability to work in a fast-paced environment to meet tight deadlines

  • Ability to problem solve and lead process improvements

  • Ability to lead cross-functional meetings and make decisions as a QA representative

  • Ability to escalate issues when necessary

  • Ability to work in a cross-functional environment

  • Ability to work in a virtual manufacturing environment

  • Demonstrated ability to work well with other accomplished professionals

  • Willing collaborator

  • Strong communication skills, both written and oral

  Additional Information:

  • The physical demands of this job are consistent with light office duties. This role requires 10-15% Domestic and International Travel

  • The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • This position’s work environment is in an office, manufacturing facility.

  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

  To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential func tions.

  Loxo@Lilly (Eli Lilly and Company) currently anticipates that the base salary for this position could range from between $110,000-162,800 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, Loxo@Lilly (Eli Lilly and Company) 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, Loxo@Lilly (Eli Lilly and Company) reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Loxo@Lilly (Eli Lilly and Company) compensation practices and guidelines will apply regarding the details of any promotion or transfer of Loxo@Lilly (Eli Lilly and Company) employees.

  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.

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