API External Manufacturing: Technical Services and Manufacturing Scientist Peptide Advisor Full-time

Job Description

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 Advisor will provide technical and scientific expertise within a dynamic external manufacturing environment. The Advisor is responsible for ensuring delivery of commercialization efforts including technical transfers, process validations, and process optimization for the peptide portfolio, including Mounjaro. 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.

Key Objectives/Deliverables:

• Provide technical oversight and stewardship for peptide manufacturing processes, including synthetic processing steps and downstream purification.
• 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 to influence process control strategies.
• 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.
• Optimize and execute site control strategies.
• Successfully deliver on strategic initiatives.
• Authors and provides guidance on Regulatory Submissions, IRs, and changes.
• Influence and implement the network technical agenda and drive continuous improvement.
• Maintaining peptide 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.
• Understand the chemistry and stability of biomolecules.
• Operate with 'Team Lilly' in mind – including coaching and mentoring of peers and other scientists.

Basic Requirements:

• Ph.D. in scientific disciplines of Biochemistry, Chemistry, Chemical Engineering, Pharmacology, or related fields, or equivalent industry experience (8 years +).
• Demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.

Additional Information

• Occasional travel required 5 – 15%.

LOCATION:

• Indianapolis, IN or Kinsale, Ireland

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 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.

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Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $123,750 – $198,000. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, 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). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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