Senior/Principal Scientist – Peptide Technical Services & Manufacturing Science (TS/MS), API

About the role

The API EM Senior or Principal Scientist will join the Technical Services/Manufacturing Sciences (TS/MS) team within the Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM). This team works within a dynamic external manufacturing environment to provide technical support and scientific expertise across Peptides and Oligonucleotides (TIDES).

Responsibilities

• Provide technical oversight and stewardship for peptide and/or oligonucleotide manufacturing 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, perform effective investigations, and disseminate actionable outputs.
• Build and maintain relationships with development partners and central technical organizations.
• Ensure proper characterization of processes and ensure effective documentation and justification of the process description, measures, acceptable ranges, and specifications.
• Experience with advanced data analytics to ensure that Proven Acceptable Ranges (PAR) and Normal Operating Ranges (NOR) align with process capability.
• Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state through process monitoring.
• Identify any leading signals of process weakness from yield/quality standpoint and proactively resolve/escalate.
• Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
• Initiate deviation records and ensure on-time closure of open records with appropriate CAPAs and effectiveness checks in place.
• Support regulatory submissions with technical input as required, author and review annual reports to regulatory agencies, and maintain awareness of regulatory best practices.
• Influence and implement the network technical agenda and drive continuous improvement with appropriate change controls in place.
• Maintain peptide/oligonucleotide processes in a state of compliance with US and global regulations.
• Understand the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
• Operate with 'Team Lilly' in mind - including coaching and mentoring of peers and other scientists.

Requirements

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

Qualifications

• Knowledge and experience with Regulatory requirements.
• Enthusiasm for changes, team spirit, and flexibility.
• Ability to influence and communicate to diverse groups on business or technical issues within the site and function.
• Demonstrated Project Management skills and ability to coordinate complex projects.

Skills

• Knowledge of cGMPs, applicable global regulatory manufacturing guidance, and corporate/industry standards.
• Proven ability to solve problems and conduct investigations.
• Excellent communication skills.
• Ability to interact with a wide variety of people, primarily external partners, process team members, and site management.

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).