[Immediate Start] Tsms-api Manufacturing Support 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 Position Brand Description The API EM TS MS person-in-plant PIP mfg scientist 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 pharmaceutical 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 person-in-plant PIP mfg 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 Providing technical oversight and stewardship for manufacturing processes Ensuring that processes are compliant with US and global regulations capable in control and maintained in a validated or qualified state Technical transfer document preparations and support activities Understanding the scientific principles required for manufacturing intermediates and drug substances including the interaction of chemistry and equipment 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 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 at the CM sites Serving as an active member of the Lilly process teams IPT JPTs GPLOTs Conformation of CAPA implementation Effective management of internal and external stakeholders Adhering to Lilly s Business Quality and Financial Systems Operating with a Team Lilly mindset Basic Requirements Minimum of 10 years relevant industrial experience in API and API intermediate Manufacturing within the technical services TS MS or small molecule process Development and scale up Demonstrated basic knowledge of small molecule API Manufacturing Familiarity with cGMP manufacturing environment and terminology Additional Preferences Excellent analytical interpersonal written and oral communication skills Ability to work independently as well as part of a team Ability to prioritize activities Good judgment and flexibility Education Requirements PhD in Organic Chemistry Chemical Engineering or Physical Chemistry Other Information Complete learning plan for API EM TS MS role 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 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 WeAreLilly