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Associate Director – Analytical Operations and Compliance, Synthetic Molecule Design and

Employer
Eli Lilly and Company
Location
Indianapolis, Indiana
Start date
Apr 12, 2024

Job Details

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.

Job Description:

At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered. When applying internally for a position, your current supervisor will receive notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.

Path/Level:

P4

Note: Employees hired on banded positions (ex: P1-P3, R1-R2, B1-B3, etc.) transfer at their current level, despite the level indicated on the job posting. For example, if a P2 candidate is selected for a P1-P3 banded position, the candidate will remain a P2 in the new role.

Company Overview:

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 39,000 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. #WeAreLilly

Organization Overview:

The Associate Director – Analytical Operations and Compliance will have responsibilities for the development areas within the Synthetic Molecule Design and Development (SMDD) Organization, which is involved in key activities for the development of synthetic drug substances and drug products starting with pre-clinical phases through commercialization. Our scientists and engineers develop innovative technical and business solutions across a portfolio of projects using their deep technical expertise to accelerate testing of the clinical hypothesis and overall drug development. Through recognizing the value of a hardworking and culturally diverse workforce, SMDD delivers on these responsibilities and helps bring the next generation of life changing medicines to patients.

Our organization is comprised of experienced, creative, and energetic process chemists, analytical chemists, formulation scientists, and engineers who collaboratively contribute to overall control strategy development, unit operation optimization and process optimization of synthetic drug candidates to support clinical trials, regulatory submission, and product commercialization.

Role Overview:

This role supports the oversight of expanding LCCI capabilities and establishment/continuous improvement of local quality system workflows for SMDD to advance quality culture and ensure quality system adherence in support of the development portfolio. The individual will meet all corporate and department objectives, facilitate on-time delivery of the portfolio, consult with business partners (both internal and external) on quality related matters, and assist in deviation oversight (investigations and change controls) to ensure adherence to regulatory and industry standards of compliance.

Key Responsibilities:

Responsibilities involve operational leadership activities including, but not limited to:

  • Provide oversight and training for Lilly Capability Center India (LCCI) resources within SMDD for successful transition into development portfolio activities. Collaborate with local scientists to identify opportunities for operational efficiency enhancements and establish workflows for LCCI integration.
  • Be a champion and thought leader for quality priority principles and compliance within the organization.  Seek out opportunities for local business process improvements to ensure quality system compliance and support implementation within SMDD.
  • Lead investigations to determine root cause, corrective actions, and ensure the written report contains the technical merit and completeness to meet regulatory expectations.
  • Mentor and guide deviation investigations and investigators. Provide advice, review, and guidance to investigator team in deviation investigations (assessment, quality impact evaluation, root cause analysis method), investigation write-up (technical writing), support data, etc. Upon assignment of an investigation immediately partner with investigation team (QA Reviewer/Approver, SMEs [subject matter experts], and necessary stakeholders) on definition and alignment of the investigation plan, required data, and timeline for completion.
  • May contribute to deviation governance teams, projects, and other quality initiatives. Collaborate to define comprehensive continuous improvement deviation management roadmaps to stay abreast of regulatory expectations and industry best.
  • Lead and execute data integrity initiatives and develop process improvements to deliver on business objectives, quality standards, and regulatory expectations.
  • Participate in regulatory inspections, assist in the preparation of key quality and compliance topics for audit and inspection readiness.

Additional Skills:

The ideal candidate ideally exhibits:

  • Thorough understanding of development of synthetic drug substances and drug products, regulatory requirements, cGMP regulations.
  • Experience in and understanding of phase-appropriate application of cGMP requirements in clinical develop environment. Demonstrated ability to troubleshoot product development issues, perform root cause analysis, and implement corrective and preventative actions.
  • Strong leadership attributes including good communication skills (written and verbal) and a strong sense of personal accountability.
  • Strong technical skills to supply business value.
  • Demonstrated critical thinking, solid judgment, and initiative taking.
  • Demonstrated success in persuasion, influence, and negotiation skills.
  • Demonstrated ability to work and accomplish results independently.
  • Demonstrated ability to interface cross-functionally and achieve goals in collaborative environments.
  • Demonstrated examples of process improvement and implementation.
  • Seek to understand, demonstrates humility, and shows curiosity for learning.
  • Ability to prioritize multiple activities and manage ambiguity.

Basic Qualifications:

  • Minimum of Bachelor’s degree in relevant Science or Engineering discipline and/or equivalent combination of work experience is required.
  • >10 years of relevant foundational experiences in analytical development, development of synthetic drug substances and drug products, quality assurance, or technical services in pharmaceutical or other regulated industries.

License/Certificate Requirements:

  • Not Applicable.

Additional Information:

  • 0-10% travel required.
  • Position requires 8-hour days, five days per week, with flexibility to support activities during shutdowns, weekends, etc.

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

Company

Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. 

Company info
Location
893 S Delaware St
Indianapolis
Indiana
46285
United States

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