Research Scientist - CMC Regulatory

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

At Lilly, we create medicines that give people new hope – to get better, feel better, live better.  It’s our purpose to create medicines that make life better for people around the world.  Lilly is looking for regulatory Chemistry, Manufacturing and Control (CMC) scientists to join us in developing and bringing life-changing new medicines to patients who need them all over the world.

We are seeking Regulatory Scientist GRA-CMC Biotechnology to be a part of the Lilly global regulatory group to support global submissions, The purpose of this role is to provide strategic, tactical and operational direction to expedite CMC development of Lilly’s portfolio and technical agenda by supporting global market registration submissions, and post-approval submissions. These activities are accomplished with a strong working knowledge of global regulations, guidelines and regulatory precedence coupled with a strong technical knowledge of CMC development and manufacturing processes. To accomplish this purpose, it is necessary for the Regulatory Scientist to develop collegial and mutually productive relationships across Lilly components, partner company components, and with Agency personnel. This role is further accomplished by a demonstrated ability to establish and/or to promote / refine key regulatory CMC positions and to effectively influence development, manufacturing, and GRA leadership on these positions.

Key Objectives/Deliverables:

• Technical knowledge of CMC drug development sciences and parenteral drug product manufacturing
• Knowledge of global CMC regulatory requirements and guidelines related to parenteral drug product manufacturing and obtaining global product registrations
• Development of regulatory strategy to ensure alignment with current and evolving global regulatory expectations
• Provide regulatory guidance to site to all teams to make well-informed decisions on development or product lifecycle planning
• Leads, preparation, review and finalization of CMC documents for registration submissions and response to questions
• Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members.
• Partners with the broader GRA organization to develop consistent regulatory approaches across sites, promote continuous learning, and to incorporate regulatory feedback into new development or manufacturing plans
• Facilitates FDA Regulated Products Annual Report
• Supports RTP Regulatory Impact Assessments for deviation and change management

Minimum Requirements:

• 10-15 years of Regulatory CMC experience or equivalent supporting biologic product development in CMC development or manufacturing roles supporting clinical phases of development and/or commercialization;   relevant experience including authoring CMC submission content, developing control strategies, and involvement in clinical trial and commercial submission processes including response to questions (less experience with advanced degree would be considered).
• Regulatory submission experience either as part of a role in a regulatory position, or equivalent experience participating in regulatory submissions, authoring and health authority interactions.
• Prior experience in parenteral drug product development, commercialization, or manufacturing
• Excellent interpersonal, written and oral communication skills
• Demonstrated leadership behaviors and negotiation and influence skills
• Ability to handle multiple competing priorities

Additional Preferences:

• Experience in planning for and participating in Health Authority meetings and/or inspections
• Demonstrated ability to assess and manage risk in a highly regulated environment
• Previous experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment
• Previous equipment qualification and process validation experience
• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles

Education Requirements:

• B.S. degree in a science, engineering, or a related field (Chemistry, Biology, Biochemistry, Pharmaceutics, Engineering, Analytical Sciences, or similar)
• Master's Degree preferred

Other Information:

• The position is for the Lilly Research Triangle Park site and during the project phase will allow for a flexible working environment with the ability to periodically work remotely based on the project phase and site activities.
• Position may require some initial travel to Indianapolis to establish specific device knowledge and establish global contacts.
• Minimal travel required

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company.  If you would like to request an accommodation for medical or religious reasons, you may do so at workplace_adjustment@lilly.com.