Person-in-Plant APIEM TS/MS Scientist

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.

The PIP role provides leadership and functional-area expertise at the designated Contract Manufacturer site, in conjunction with API EM contract manufacturing personnel working at Lilly affiliate sites (e.g., Indianapolis, Kinsale, Puerto Rico) to achieve the reliable and compliant manufacture of API drug substance that meets predetermined global quality standards.

The PIP role is responsible for:

•        Day to Day production support

•        Monitoring ongoing production support (e.g., production meeting attendance)

•        Periodic housekeeping / fit & finish walk-throughs with area management.

•        Tracking of resolution of identified issues

•        Practice vs procedure walk throughs with management

•        Serving as an active member of the Lilly process and applicable PLOTs

•        Conformation of CAPA implementation

•        Effective management of internal and external stakeholders

•        Adhering to Lilly’s Business, Quality, and Financial Systems

Key Objectives/Deliverables:

• Contributing to the technical transfer support activities.
• Providing technical oversight and stewardship for manufacturing processes.
• Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
• Ensuring that processes are compliant with US and global regulations, capable, in control, and maintained in a validated or qualified state
• Leading resolution of technical issues, including those related to control strategy and manufacturing.
• Executing technical projects to improve process control, yield, purity, and/or productivity.
• Ensuring processes are executed according to approved process flow document.
• Preparing relevant technical documents, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, process flow documents (PFD), validation master plans (VMP), etc.
• Developing and monitoring established metrics in real-time to assess process variability and capability.
• Ensuring that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
• Analyzing data and ensuring appropriate documentation.
• Influencing and implementing the API network technical agenda and driving continuous improvement.
• Building and maintaining relationships with development and central technical organizations.

Basic Requirements:

• 5+ years of demonstrated experience with cGMP manufacturing
• Or MS or PhD in STEM discipline with 2+ years of demonstrated experience with cGMP manufacturing
• Demonstrated ability to function in a cross-functional team environment and to provide technical leadership
• Demonstrated ability to work independently and to manage/prioritize competing priorities
• Strong written and verbal communications skills with various audiences
• Ability to influence diverse groups and manage relationships
• Willingness to relocate to contract manufacturing site for an estimated 3-year assignment before returning to designated Lilly site

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 (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request 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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