- Lead the API EM QC team, providing coaching / feedback to develop QC employees, including performance management, talent assessments, mentoring, succession planning, and organizational planning.
- Review and approve relevant technical documents, such as change controls, regulatory submissions, deviations, validations, procedures, APRs, PFDs, etc. as applicable.
- Manage internal QC experimental projects to improve method performance robustness and overall analytical control strategies for the API EM portfolio.
- Guide staff to ensure creation and maintenance of reference standards to support the API EM portfolio.
- Maintain 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.
- Build working relationships with API EM technical leaders in QC, QA, and TS/MS, and with key internal and external partners.
- Work closely with the API EM QC technical leadership to coordinate outsourced QC activities at CMs and external laboratory partners. 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 cGMP QC laboratory experience.
Additional Skills/Preferences: - Demonstrated coaching and mentoring skills.
- Previous experience supervising people and leading teams.
- Demonstrated technical knowledge in laboratory analytical techniques, including, but not limited to, chromatographic, spectroscopic, and/or microbiological assays.
- Thorough technical understanding of analytical laboratory compliance requirements and regulatory expectations.
- Demonstrated strong problem-solving skills.
- Strong verbal and written communication skills.
- Demonstrated strong interpersonal interaction skills, with a proven ability to influence diverse groups and manage relationships.
- Demonstrated leadership skills (decision making, prioritization, mentoring, conflict resolution).
- Demonstrated understanding of statistical tools and analysis.
- 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 10-20 percent Travel) requiring a passport. 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 ( ) 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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Associate Director API External Manufacturing-QC - Indianapolis, United States - Eli Lilly and Company
Description
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 Associate Director (AD) - Quality Control provides analytical leadership for the API External Manufacturing (API EM) portfolio. The AD is responsible for leading scientists involved in technical and compliance aspects of analytical methods for API manufacturing at contract manufacturers (CMs) based upon sound scientific principles driving towards predictable and robust analytical methods and control strategies. The AD leads the technical staff responsible for the development and implementation of analytical methods and capabilities for continuous optimization and improvement with the CMs. This includes workload planning, ensuring compliance of analytical methods with regulatory expectations, performance planning, coaching of team members, and overall customer service while developing employees. It also includes day-to-day commercial portfolio support activities.
