Advisor-Quality Control

1 month ago

Kinsale, Ireland Lilly Full time

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).



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

  • Senior Associate

    1 month ago

    Kinsale, Ireland Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. There is an opening for production QA Senior Associate to support our growing Small Molecule/Peptide Operations. This new role maybe developed to introduce a shift pattern to support the Small Molecule Business. Lilly Kinsale has a Hybrid Working Policy. Main...

  • Digital Plant Representative

    3 weeks ago

    Kinsale, Ireland Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. Responsibilities: The digital plant representative will primarily be responsible for supporting the implementation of robust control strategies in continuous manufacturing processes through digital solutions including the use of models. The digital plant...

  • Senior Associate

    3 weeks ago

    Kinsale, Ireland Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. Senior Associate - QA Small Molecule Operations There is an opening for production QA Senior Associate working in Small Molecule Operations. This new role maybe developed to introduce a shift pattern to support the Small Molecule Business. Lilly Kinsale has a...

  • Sr. Laboratory Analyst

    1 month ago

    Kinsale, Ireland Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you...

  • API EM Process Engineer

    2 weeks ago

    Kinsale, Ireland Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. Position Brand Description: The position of API EM Engineer [ Synthetic Peptide Synthesis and Purification / Small Molecule ] reports to the Associate Director - Engineering API EM and provides technical leadership and expertise in conjunction with API EM...

  • Associate Director API External Manufacturing-QC

    1 month ago

    Kinsale, Ireland Lilly Full time

    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...

  • Senior Analytical Scientist

    3 weeks ago

    Kinsale, Ireland Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. The Senior Analytical Scientist provides the analytical leadership for all aspects of advanced analytical technologies and methods within the Analytical sciences/Quality control characterisation area. The role will be responsible for provision of analytical...

  • Sr. Scientist mAb TSMS API EM

    1 month ago

    Kinsale, Ireland Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. Organisation Overview: Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The API EM TS/MS Sr. Scientist...

  • Occupational/Industrial Hygienist

    1 month ago

    Kinsale, Ireland Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you...

  • Lab IT

    1 month ago

    Kinsale, Ireland Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. Main Purpose and Objectives of Position The Lab IT & CSV Professional is a member of the site IT & CSV team which has responsibility for the installation, validation and maintenance of a wide variety of computerised instrument systems in both laboratory and...