Lilly Associate Director-Project Management-TS/MS in Kinsale, Ireland
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 35,000 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.
For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.
Position Brand Description:
The CMC Project Management Professional is responsible for working with technical leadership to define and execute the technical agenda for M&Q’s processes and products through leadership of a molecule’s MIT or GPLOT. The Project Manager is expected to have Commercial Product Knowledge, Leadership and Business Acumen, and Project Management skills. The Project Manager will lead execution of a technical agenda that delivers value for both the Business Unit and the M&Q organizations. The Project Manager must have strong relationship and communication skills and an ability to influence team members and leadership at manufacturing sites, within core M&Q functions, and with the relevant Business Unit. A person in this position has a CM&C and/or Manufacturing background and is expected to apply project management principles as guided by PMBOK, including robust risk management for cross-functional teams. They will also participate in process improvement activities within manufacturing and project management.
Leadership of a Manufacturing Integration Team (MIT) or Global Post Launch Optimization Team(s) (GPLOTs) and other cross-functional teams.
With Technical Leadership, define and execute integrated technical agenda, facilitate QPPA/OPV, APR and GPA reviews to ensure the processes are in control and capable, actively manage network projects, and lead teams to ensure on time delivery of projects.
Project Management expertise:
Accountable for meeting Single Process Map and World Class Commercialization deliverables with appropriate technical rigor on time, on budget and in scope through the development of integrated project timelines.
Applies knowledge of project management tools and processes. Drives team decision making process to resolve project issues. Develops a risk management strategy for individual projects and ensures contingency plans are developed. Manages change control process for the project. Evaluates new requests for manufacturing or product changes. Drives development of draft operational plans for proposed new projects and ensures that data is available to allow evaluation of new projects.
Provide CMC expertise and leadership with Business Unit, Development and M&Q partners.
Ensure team activities meet priority needs of BU and M&Q. Ensure technical activities meet rigorous standards and align with regulatory and supply chain requirements.
Support the CM&C teams in developing strategies and implementing operational plans to deliver API, drug product formulations, registration stability lots, clinical trials materials, and other materials required to support/implement a particular project.
Manage external partnerships as needed for implementation of the technical agenda.
BSc or MSc in chemistry, biology, engineering or equivalent scientific degree
7+ years of experience in more than one CM&C function or manufacturing experience
Location: Position can be hosted by a Lilly site/affiliate
Experience in Operations, TS/MS, QA or QC, Regulatory, or Supply Chain within pharmaceutical manufacturing.
Green Belt or Black Belt experience
Technical transfer experience
Masters in Project Management, PMP certification, PE or MBA.
Demonstrated successful leadership of cross-functional teams
Demonstrated project management capability.
Knowledge of the CMC aspects of drug development and manufacturing.
Strong interpersonal and teamwork skills.
Strong self-management and organizational skills.
Oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization.
Other Information: Some travel (domestic and international) may be required.
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 ( LillyRecruitingCompliance@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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).