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 t