Advisor-Quality Control

3 weeks ago

Indianapolis, United States Eli Lilly and Company Full time

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.

Responsibilities:

The API EM Advisor-Quality Control provides technical analytical leadership for the API External Manufacturing (API EM) portfolio.  This role will provide overall stewardship for peptide drug substance products and is responsible for leading scientists involved in technical aspects of analytical methods for API manufacturing and developing a technical agenda based on sound scientific principles driving towards predictable and robust analytical methods and control strategies.  The Advisor mentors the technical staff responsible for the development and implementation of analytical methods and capabilities for continuous optimization and improvement with contract partners.  This includes workload planning, ensuring compliance of analytical methods with regulatory expectations, performance planning feedback, and overall customer service while developing employees.  Key partners for the role include the TS/MS Advisors within API EM, GQL, CTC, PR&D, and the individual GPLOT and flow teams.  This is a technical ladder eligible position.

  • Serve as an analytical resource and mentor for scientists, managers, and other disciplines.
  • Influence and manage the QC technical support for non-routine (e.g., deviations, changes, complaint) investigations, including consultation on quality and stability issues with the API EM network of contract partners.
  • Review, author and/or approve relevant technical documents, such as change controls, regulatory submissions, expert opinions, deviations, validations, procedures, APRs, PFDs, etc. as applicable.
  • Manage QC experimental projects to improve method performance robustness, and overall analytical control strategies for the API EM portfolio.
  • Support identification and development of new analytical technologies into internal API EM laboratories and subsequent implementation for the improvement of existing analytical control strategies.
  • Own the QC technical agenda for the API EM portfolio, including maintaining a technical understanding of the regulations applicable to laboratory testing in a cGMP environment.
  • Identify and resolve laboratory safety issues within the API EM laboratories.


    Basic Requirements:

    • Bachelor’s degree in a scientific field related to the laboratory, such as Chemistry, Biological Sciences or related a Life Sciences field.
    • Minimum of five years of prior laboratory experience


      Additional Skills/Preferences:

      • Advanced degree in a scientific field related to the laboratory, such as Chemistry, Biological Sciences or related a Life Sciences field
      • Demonstrated technical knowledge in laboratory analytical techniques, including, but not limited to, chromatographic, spectroscopic, and/or microbiological assays.
      • Thorough technical understanding of compliance requirements and regulatory expectations.
      • Demonstrated strong problem-solving skills.
      • Strong oral and written communication skills.
      • Demonstrated strong interpersonal interaction skills, with a proven ability to influence diverse groups and manage relationships.
      • Demonstrated technical leadership skills (decision making, prioritization, mentoring, conflict resolution).
      • Demonstrated coaching and mentoring skills
      • Demonstrated skills in root cause analysis and application of statistical skills.
      • Demonstrated flexibility when faced with changing priorities
      • Strong attention to detail
      • Strong self-motivation


        Additional Information:

        Role can be located in either Indianapolis, IN or Kinsale, Ireland supporting External Manufacturing activities with some required travel to Contract Manufacturer sites (Approximately 20 percent Travel).

        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

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