Advisor/Sr.Advisor-Synthetic Peptide Process development Scientist

Job Summary

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.

Responsibilities

Safety culture lab management

• To ensure that appropriate personal protective equipments in the laboratory premises are available and follows the safety precautions.
• Ensure the good administration and housekeeping of the PRD department work area.

People Leadership

• Build, lead, and develop a high-performing team of process chemists aligned with Lilly culture.
• Set clear objectives, provide coaching, conduct performance reviews, and support career development.
• Promote a culture of scientific excellence, collaboration, safety, and compliance.
• Work as a team and take responsibility with accountability.

Technical

• 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

• Ph.D. in scientific disciplines of Biochemistry, Chemistry, or related fields, or equivalent industry experience / Ph.D + Post Doc in Chemistry (focusing more Peptide chemistry) with 12+ years

Other Information

• Some travel (domestic and international) less than 5% may be required.

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