01Key Responsibilities
- The employee leads technical aspects of drug substance manufacturing including process optimization, technical transfers and development of the technical agenda.
- 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.
- The successful candidate should have a proven track record of driving technical agendas and influence externally in the peptide space.
Basic
02Requirements
- Provide technical oversight and stewardship for peptides and manufacturing processes.
- Leads resolution of technical issues including those related to control strategy and manufacturing.
- Proven experience at leading post launch technical agendas and delivering projects that have driven substantial step changes in manufacturing (specific to M&Q; and may not be required for development).
- Employ excellent communication skills to manage internal and external relationships.
- Manage project work through active coaching and delegation of junior scientists and engineers.
- 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.
- Maintaining peptide processes in a state of compliance with US and global regulations.
- Understanding the scientific principles required for manufacturing intermediate and drug substances, including the interaction of chemistry and equipment.
- Understand the chemistry and stability of peptides from a first principles perspective.
Education Requirement :
- PhD in scientific disciplines of Biochemistry, Chemistry, Chemical Engineering, or related fields, or equivalent industry experience.
- PhD + Post Doc in Chemistry (focusing more Peptide chemistry) with 12+ years
Other Information :
- Some travel (domestic and international) less than 5% may be required.
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 .