Sr. Principle

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 employees 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 put people first and are looking for people who are determined to make life better for people around the world.

Company Overview

Lilly is a leading innovation-driven corporation developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly makes life better – through medicines and information – for some of the world's most urgent medical needs. Founded over 145 years ago, the company values excellence, integrity, and respect for people. Lilly has sustained a culture that recognizes talent for innovation and a passion for making a difference by finding treatments for challenging diseases. Join our team – and make a difference in improving health for people all over the world

Job Description

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. Principal Scientist will provide technical and scientific expertise within a dynamic external manufacturing environment. The role focuses on ensuring delivery of commercialization efforts including technical transfers, process validations, and process optimization for the Small Molecule portfolio. This position requires comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real-world solutions.

Key Objectives/Deliverables

- Provide technical oversight and stewardship for Small Molecule manufacturing processes.
- Lead resolution of technical issues including those related to control strategy and manufacturing.
- Employ excellent communication skills to manage internal and external relationships.
- Build and maintain relationships with development and central technical organizations.
- Ensure proper characterization of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, and specifications (and the justification of these measures, acceptable ranges, and specifications).
- Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state.
- Optimize and execute site control strategies.
- Deliver on strategic initiatives.
- Influence and implement the network technical agenda and drive continuous improvement.
- Maintain processes in a state of compliance with US and global regulations.
- Understand the scientific principles required for manufacturing drug substances, including the interaction of chemistry and equipment.
- Operate with a team mindset, including coaching and mentoring of peers and other scientists.

Basic Requirements

- Master’s Degree or higher in a scientific discipline such as Chemistry or related field, and 8+ years of industry experience.
- Demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.

Additional Information

- Occasional travel required 5–15%.

Location

- Kinsale, Ireland

Equal Employment Opportunity

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form at the following URL for further assistance. This is for individuals requesting an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly 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.

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