IDAP Commercialization Project Manager

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 Commercialization PM at Indianapolis Device Assembly and Packaging (IDAP) within the Technical Services and Manufacturing Sciences (TS/MS) team, provides project management oversight to achieve the reliable and compliant manufacture of new device and packaged products to support Chemistry, Manufacturing, and Control (CMC) agendas and timelines.  This role serves as the conduit between development and the site, for projects spanning from clinical trials to initial commercial launches including the associated technology transfer activities.

 

The Commercialization PM is responsible for leading technical teams to commercialize devices and packaged products. This role is expected to demonstrate Leadership, Business Acumen, Project Management skills, and Commercialization/Technology Transfer Process Knowledge.  Additionally, the role will interface outside the manufacturing site with Network Project Managers, CMC Project Managers, and DDCS Project Managers.

 

Key Objectives/Deliverables:

Understand the scientific principles required for Device Assembly and Packaging operationsManage the IDAP commercialization portfolio for assigned projects – including driving prioritization for the site with an understanding of resourcing and constraintsLead cross functional teams through the Tech Transfer Process for Commercialization in IDAPDrive technical teams towards an established timeline that meets customer requirements and supports CMC and Regulatory timelinesResponsible for Tech Transfer Plans/Reports and delivery of Commercialization Gate Reviews to site leadershipWork within or lead cross-functional teams to implement TS/MS objectives and deliver on business plan, commercialization, and quality objectivesSupport identification and development of new manufacturing technologies and processes in IDAP to support commercializationOptimize commercialization process in IDAP by identifying opportunities for efficiency and consistency between new molecule commercialization efforts

 

Minimum Requirements:

Bachelor’s degree required Minimum 3 years work experience preferred (GMP/Pharma and PM experience preferred)PMP Certification preferredTechnical / Scientific knowledgeGood written and oral communicationsClear understanding of cGMPsGood teamwork and interpersonal skillsComputer adeptness including hosting virtual meetings with cross functional teams

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.

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