24 Aug
|
Eli Lilly
|
Hyderabad
24 Aug
Eli Lilly
Hyderabad
Job Summary
The position of Principal Technical Services Rep - APIEM reports to the TSMS Director - Peptides API EM and provides technical leadership and expertise in conjunction with API EM contract manufacturer personnel in the reliable supply and commercialization of medicines with safety first and quality always by:
- Developing and sustaining process knowledge in order to ensure the execution of the appropriate product, process, and operational control strategy at the Contract Manufacturer (CM).
- Direct and Indirect interaction with CM personnel to ensure reliable supply via the CM execution of the operational control strategy.
- Participation with internal or CM resources in technical transfer, process validation, and process data monitoring.
- Adherence to the expectations of the Lilly Red Book when carrying out interactions with API EMs CMs.
Key Objectives/Deliverables
The candidate will be responsible for process monitoring, response to issues, and improvements where necessary.
A solid understanding of manufacturing principles and Lilly systems is required to ensure those same standards are applied to the external contract manufacturers.
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.
Responsibilities
Build and Sustain Process Team Relationships
- Utilize past experiences with unit operation control to provide insight and feedback to members of the Lilly / CM Joint Process Team (JPT).
- Employ excellent communication skills to manage internal and external relationships.
- Build and maintain relationships with development and central technical organizations.
- Operate with Team Lilly in mind - including coaching and mentoring of peers and other scientists.
Develop and Sustain Process Knowledge
- Provide technical oversight and stewardship for peptide
📌 Principal TSMS (Hyderabad)
🏢 Eli Lilly
📍 Hyderabad