Sr. Scientist Technical Services/Manufacturing Science API-EM

About the role

The API-EM TS/MS (Technical Services / Manufacturing Science) Scientist will provide technical and scientific expertise within a dynamic external manufacturing environment. The 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.

Responsibilities

• Provide technical oversight for biologics manufacturing processes, leveraging a strong technical foundation and previous experience supporting these processes.
• Lead the 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).
• Avoid non-compliance, capability, in-control, and maintain in a validated or qualified state.
• Influence and implement the network technical agenda and drive continuous improvement.
• Maintain biologic processes in a state of compliance with US and global regulations.
• Understand, justify, and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
• Operate with 'Team Lilly' in mind.

Requirements

• Bachelor's degree in scientific disciplines of Biotech, Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Biotech/Biochemistry strongly preferred).
• 3+ years of demonstrated hands-on working experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.

Qualifications

• Authorized to work in the United States on a full-time basis.

Skills

• Strong understanding of regulatory requirements and their application in a manufacturing environment.
• Proficient in data management practices across manufacturing operations.
• Adaptable, collaborative mindset, and positive attitude toward change.
• Proven ability to effectively communicate and influence across diverse technical and business teams.
• Skilled in managing and delivering complex, cross-functional initiatives.
• Demonstrated project management expertise with a track record of coordinating and executing multifaceted projects.

Benefits

Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Pay

The anticipated wage for this position is $66,000 - $171,600.

Schedule

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).