Executive Director - Process Chemistry - Oligonucleotides

Lilly•Indianapolis, IN

55d•Onsite

About The Position

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 experienced and creative candidates with experience in chemistry, manufacturing and control (CMC) of oligonucleotides to participate in a wide range of activities. This technical role will support emerging synthetic needs across the rapidly evolving Lilly Genetic Medicines (LGM) portfolio. 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 oligonucleotides and their conjugates as well as oligonucleotide purification, isolation, and formulation. The position presents an opportunity to lead CMC activities to support clinical trials, product commercialization, and regulatory submissions of oligonucleotide therapeutics. Developing and working with both internal manufacturing (Lilly Medicine Foundry) and external contract manufacturing organizations (CMOs) to support oligonucleotide synthesis, tech transfer and campaign execution will be important aspects of this role.

Requirements

PhD degree in a relevant scientific discipline with 5+ years of experience (synthesis, oligonucleotide experience, solid phase synthesis, CMC)
OR MS degree with 8+ years of relevant experience (synthesis, oligonucleotide experience, solid phase synthesis, CMC)

Nice To Haves

Experience within the pharmaceutical sector is preferred. Prior experience in active ingredient development and associated formulated product is acceptable. Experience with developing chemical processes from mid-development cycle (proof of concept) to product commercialization
Experience in development / CMC including quality and regulatory interactions is expected
Experience with technical transfer of processes into manufacturing operations
Good interpersonal skills and a sustained tendency for collaboration.
Demonstrated initiative and appropriate risk taking.
Demonstrated technical proficiency and ability to create ideas for future work plans.
Strong technical skills to supply business value.
Knowledge and experience with management of a technical project.
Demonstrated leadership capabilities especially in a team environment.
Ability to prioritize multiple activities and manage ambiguity.
Ability to influence others to promote a positive work environment.
Demonstrated success in persuasion, influence and negotiation.

Responsibilities

Bring an extensive knowledge of oligonucleotide development to SMDD and use this expertise to grow internal capabilities through coaching, mentorship, and leadership.
Possess fluent knowledge in modern synthetic organic and nucleic acid chemistry methods with the drive to challenge existing methods, define new manufacturing technologies, and apply those to deliver a portfolio and address key CMC challenges.
Lead a cross-disciplinary team to evaluate and refine manufacturing routes, technologies, and practices to deliver LGM portfolio.
Exhibit a high learning agility with the ability to understand and exploit new scientific concepts and methods across multiple disciplines; strong skills related to automated reactor platforms and purification technologies; be able to apply these learnings to a portfolio of small molecule, oligonucleotide, and synthetic peptide, and other emerging synthetic modalities.
Provide examples of novel contributions to chemical design and mechanism-based problem solving as part of project driven goals such as total synthesis, novel methodology development and oligonucleotide synthesis. These examples should also be reflected in a strong publication record in peer reviewed journals.
Possess solid understanding in unit operation design, process modeling, process equipment selection, and scale-up methodologies; build and apply groundbreaking technology and novel platforms within a time constrained environment.
Provide technical leadership in the scale-up and demonstration of new chemical processes in development and commercial scale equipment; collaborate with internal and external manufacturing partners to develop robust chemical processes that are readily amenable to efficient drug substance manufacturing for both clinical and commercial settings.
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.
Possess deep understanding of the external global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing authorization applications.
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.

Benefits

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, 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).

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