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Organization Overview: At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered. When applying internally for a position, your current supervisor will receive notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying. 

Position Description

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.

A strong understanding of manufacturing principles and Lilly systems is required to ensure those same standards are applied to the external contract manufacturer.  The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards. The position requires working cross-functionally within the site and other functions to deliver on technical objectives.

The Active Pharmaceutical Ingredient - External Manufacturing Organization (API EM) TS/MS Person-in-Plant (PIP) Scientist provides the technical support required to achieve the reliable and compliant manufacture of the API External Manufacturing (API EM) portfolio which includes raw materials, intermediates, and bulk drug substances.  The PIP Scientist provides technical support and oversees the CM facility operations.  The PIP scientist is a member of IPT/JPT and contribute as a liaison between the IPT and CM process team.

Key Objectives/Deliverables:

The TS/MS Scientist provides technical supports for assigned API intermediate and API manufacturing processes.. They are a member of IPT/JPT and contribute as a liaison between the IPT and contract manufacturing (CM) process team. 

Detailed responsibilities include…

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 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).Understanding, justifying, and documenting the state of validation with data that evaluate the
capability of the manufacturing process to meet its stated purpose.Preparation of relevant technical documents, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, 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.Writing technical reports and documents.Influencing and implementing the API network technical agenda and driving continuous improvement.Building and maintaining relationships with development and central technical organizations.Day to Day production supportMonitoring ongoing production support (e.g., production meeting attendance)Periodic housekeeping / fit & finish walk-throughs with area management.Tracking of resolution of identified issuesPractice vs procedure walk throughs with managementServing as an active member of the Lilly process and applicable PLOTsConformation of CAPA implementationEffective management of internal and external stakeholdersAdhering to Lilly’s Business, Quality, and Financial SystemsOperating with a ‘Team Lilly’ mindset

Basic Requirements:

Relevant industrial experience in any of the following disciplines such as API Manufacturing, TS/MS, Quality Control, Quality Assurance, or Development

BS in STEM discipline (Chemistry/Biochemistry strongly preferred) with +5 years experience in cGMP manufacturing;  Or MSc. Or PhDin STEM discipline with; relevant experience with cGMP manufacturingDemonstrated ability to function in a cross-functional team environment and to provide technical leadershipDemonstrated ability to manage and prioritize competing prioritiesStrong written and verbal communications skills with various audiencesAbility to influence diverse groups and manage relationshipsWillingness to relocate to contract manufacturing site or an estimated 3-year assignment before returning to designated Lilly site

Additional Preferences:

Knowledge and experience with Regulatory requirementsKnowledge of data management practices across manufacturingRelevant industrial experience in any of the following:  API Manufacturing, TS/MS (Technical Services/ Manufacturing Sciences), Quality Control, Quality Assurance, or DevelopmentDemonstrated basic knowledge in small or large molecule API Manufacturing

Education Requirements:

MSc or PhD  in scientific disciplines of Biochemistry, Organic Chemistry, Chemical Engineering, Physical Chemistry, Bioanalytical Chemistry, or Analytical Chemistry.

Other Information:

Tasks require entering manufacturing areas which require wearing appropriate PPE.Domestic and International Travel (variable, can approach 20%)

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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