Sr. Scientist mAb TSMS API EM

3 weeks ago

Kinsale, Ireland Lilly Full time

We’re looking for people who are determined to make life better for people around the world.

Organisation Overview:

Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The API EM TS/MS Sr. Scientist will provide technical and scientific expertise within a dynamic external manufacturing environment. The Sr. Scientist is responsible for providing technical support to achieve the reliable and compliant manufacture of API drug substance at external contract manufacturing groups to predetermined global quality standards. This person interacts daily with a wide variety of people, primarily external partners team members and site management.

The candidate will be responsible for process monitoring, response to issues, and improvements where necessary. A strong understanding of manufacturing principles, technical transfers and Lilly systems is required to ensure those same standards are applied to the external contract manufacturers.

This is a Downstream mAb’s position. 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:

Provide technical oversight for monoclonal antibody manufacturing processes. Leads resolution of technical issues including those related to control strategy and manufacturing. Employ excellent communication skills to manage internal and external relationships. Build and maintain relationships with development and central technical organizations. Ensure 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). Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state. Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose. Influence and implement the network technical agenda and drive continuous improvement. Maintaining mAb processes in a state of compliance with US and global regulations Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment. Operate with ‘Team Lilly’ in mind - including coaching and mentoring of peers and other scientists.

Basic Requirements:

Bachelors in scientific disciplines of Biotech, Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Biotech/Biochemistry strongly preferred) 3+ years of demonstrated experience and proficiency with downstream pharmaceutical manufacturing and working knowledge of regulatory expectations.

Additional Preferences:

Knowledge and experience with Regulatory requirements Knowledge of data management practices across manufacturing Enthusiasm for changes, team spirit and flexibility Ability to influence and communicate to diverse groups on business, or technical issues within the site and function Proficiency in delivering complex tasks and/or tasks that are cross-functional Demonstrated Project Management skills and ability to coordinate complex projects

Additional Information:

Some travel (

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