Principal 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 35,000 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.

**Organization Overview**:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

**Position Description**:

- This role is responsible for all technical activities related to the support of external manufacturing as defined in the Global Contract Manufacturing Standards.
- This role is the process expert for the step(s) of the product(s) and process(es) for each contract manufacturing relationship. This role is a member of the joint process team (JPT) and has direct responsibility for oversight of the day to day operations and technical agenda at the CM.

**Responsibilities**:
**Support On-Going CM Operations by providing technical oversight at the Joint process Team as Primary Loop support**

The TS/MS Rep in the Joint Process team should be or become the process expert with regards to the process steps or processing equipment within the scope of the process team including:

- Understanding the purpose and the science of the process and have a thorough understanding of the entire process
- Understanding and owning the process control strategy including the key process parameters, critical quality attributes, and the historic and potential failure modes of the process
- Knowing the product process, development and validation history
- Translating process requirement and education to the Joint Process team members
- Documenting work and learnings in an official source such as Process Flow Diagrams.

The TS/MS Rep in the joint process team should ensure that the process is maintained in a validated / capable state that includes:

- Participating in the design and execution process, cleaning, and sterility and Bioburden control (for parenteral product) strategies and validation process (PV/PPQ) and oversight any documentation associated as required.
- Having a holistic understanding of the process, and its associated equipment, facilities, computer system and operations and provide oversight to any PQ activity at the CMs.
- Ensure that there is an accurate process flow diagram that describes the process, control strategy, process parameters and critical quality attributes
- Ensure process remains in a validated state through routine monitoring
- Ensure timely completion of annual product reviews (APRs) and Ongoing Process Verification (OPV), with action plans defined and monitored to ensure processes are in control, capable and in continuous improvement.
- Assist Quality and Supply Chain personnel in the timely completion of SCR, Quality Agreement and MRDs, as necessary
- Assist to the CMs on the preparation of any audit from Lilly (GQAAC) or any external agency that impact Lilly products.

The TS/MS Rep in the process team should provide support to management of daily operations by:

- Using statistical tools to understand and reduce sources of variability and continuously improve the process.
- Using data history and other sources to extract relevant process parameters.
- Leading process related root cause analysis and providing expert process knowledge in all incident investigations.
- Owning process related deviations, complaints, corrective and preventative actions, and changes.
- Assist the CMs on the batch records and revisions, and assure they remain accurate.
- Serving as a liaison to other scientific and/or technical experts outside the process team such as Secondary Loop SMEs and Molecule Stewards,

The TS/MS Rep in the process team should own the process capability and yield variables ad identify opportunities for improvement. This includes:

- When variation arises, the TS/MS Rep should be able to assist the process team identifying if the variation source is from common or special cause.
- Analyze the process routinely in order to identify vulnerabilities and inefficiencies of the process and promote improvement projects
- Monitor the status of processes to ensure they are consistent with, corporate standard expectations and the continuous improvement strategy.

**Relationship with CMO**
- Make regular communication with and visits to External Manufacturers to ensure current awareness of their operations and to maintain a strong wor