TSMS-API Manufacturing Support Scientist

JOB DESCRIPTION

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.

Basic Requirements :

Additional Preferences :

Education Requirements :

Other Information :

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 (

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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