BioSpace
Senior Principal Scientist – TSMS SM
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. Principal Scientist will provide technical and scientific expertise within a dynamic external manufacturing environment. The role is focused on ensuring delivery of commercialization efforts including technical transfers, process validations, and process optimization for the Small Molecule portfolio. This position requires comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real-world solutions.
Company Overview Company: Lilly. Headquarters: Indianapolis, Indiana. Lilly is a leading innovation‑driven corporation developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Founded over 145 years ago, Lilly values excellence, integrity, and respect for people.
Key Objectives/Deliverables
Provide technical oversight and stewardship for Small Molecule manufacturing processes.
Lead 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.
Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state.
Optimize and execute site control strategies.
Successfully deliver on strategic initiatives.
Influence and implement the network technical agenda and drive continuous improvement.
Maintain processes in a state of compliance with US and global regulations.
Understand the scientific principles required for manufacturing 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
Master’s Degree or higher in a scientific discipline of Chemistry or related fields, and 8+ years industry experience.
Demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.
Additional Information
Occasional travel required 5–15%.
Location Kinsale, Ireland OR Indianapolis, US
Equal Opportunity Statement 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 (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. 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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Company Overview Company: Lilly. Headquarters: Indianapolis, Indiana. Lilly is a leading innovation‑driven corporation developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Founded over 145 years ago, Lilly values excellence, integrity, and respect for people.
Key Objectives/Deliverables
Provide technical oversight and stewardship for Small Molecule manufacturing processes.
Lead 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.
Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state.
Optimize and execute site control strategies.
Successfully deliver on strategic initiatives.
Influence and implement the network technical agenda and drive continuous improvement.
Maintain processes in a state of compliance with US and global regulations.
Understand the scientific principles required for manufacturing 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
Master’s Degree or higher in a scientific discipline of Chemistry or related fields, and 8+ years industry experience.
Demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.
Additional Information
Occasional travel required 5–15%.
Location Kinsale, Ireland OR Indianapolis, US
Equal Opportunity Statement 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 (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. 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.
#J-18808-Ljbffr