Advisor/Senior Advisor – Process Chemistry Peptides & Oligonucleotides

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 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.

The Synthetic Molecule Design and Development (SMDD) is responsible for the development of synthetic drug substances and drug products from the pre-clinical phase through commercialization. Our scientists and engineers develop innovative technical solutions to advance an existing portfolio that includes small molecules, synthetic peptides, oligonucleotides, and other emerging therapeutic modalities to help bring the next generation of life-changing medicines to patients.

Our SMDD team is looking for creative candidates with experience in chemistry, manufacturing and control (CMC) of peptides and oligonucleotides to participate in a wide range of activities. This technical role will support emerging synthetic needs across the rapidly evolving portfolio of medicines. The scientist will collaborate with a growing team comprised of chemists, analysts, and engineers aimed at development and optimization of existing methods and exploration of novel synthetic approaches to peptide & oligonucleotides and their conjugates as well as purification, isolation, and formulation. The position presents an opportunity to lead CMC activities to support clinical trials and regulatory submissions of peptide/oligonucleotide therapeutics. Developing and working with both internal manufacturing (Lilly Medicine Foundry) and external contract manufacturing organizations (CMOs) to support synthesis, tech transfer and campaign execution will be important aspects of this role.

Position Responsibilities:

Top candidates for this position will be expected to:

• Synthesize complex peptide/oligonucleotide active pharmaceutical ingredients (APIs) using both established and ground-breaking technologies in synthetic chemistry, chemical engineering, and continuous manufacturing.

• Possess fluent knowledge in modern synthetic organic, peptide and nucleic acid chemistry methods with the aim to challenge existing methods, define new manufacturing technologies, and apply those to deliver a portfolio and address key CMC challenges.

• Exhibit a high learning agility with the ability to understand and exploit new scientific concepts and methods across multiple disciplines; be able to apply these learnings to a portfolio of small molecule, oligonucleotide, and synthetic peptide, and other emerging synthetic modalities.

• Possess solid understanding in unit operation design, process modeling, process equipment selection, and scale-up methodologies.

• Provide technical leadership in the scale-up and demonstration of new chemical processes in development scale equipment; collaborate with internal and external manufacturing partners to develop robust chemical processes that are readily amenable to efficient drug substance manufacturing.

• Collaborate across internal CMC networks (Drug Product Delivery, Project Management, Quality, Manufacturing, and Regulatory) to implement and deliver material and information for clinical trials and regulatory submissions.

• Design experimental laboratory plans in support of route and process design, definition, optimization, and technology transfer objectives.

• Support generating data to be used in regulatory filings. Possess ability to address key CMC regulatory questions that enable clinical studies.

• Identify, partner and develop external chemistry innovations to complement existing internal capabilities and incorporate these innovations across the portfolio of assets.

• Embrace diversity in thoughts, background, and experiences to deliver solutions. Encourage team members to take initiative and accountability to achieve goals and draw out and encourage others to share knowledge on challenging technical issues.

• Engage the external chemistry environment through presentations, publication at external symposia or consortia. These activities are expected to advance the internal Lilly portfolio and help create new opportunities.

• Lead through ambiguity, welcome and rapidly adjust to change, and identify and drive superior methods to accomplish tasks.

Minimal Qualifications:

• PhD degree in a relevant