Eli Lilly and Company

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.. Developing and working with external contract manufacturing organizations (CMOs) to support external oligonucleotide synthesis, tech transfer and campaign execution will be an important aspect of this role.. 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.. PhD degree in a relevant scientific discipline with 5+ years of experience (synthesis, oligonucleotide experience, solid phase synthesis, CMC). MS degree with 8+ years of relevant experience (synthesis, oligonucleotide experience, solid phase synthesis, CMC)

scientific director

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. Within Lilly Research Laboratories, Synthetic Molecule Design and Development (SMDD) is involved in key activities for the development of synthetic active pharmaceutical ingredients (API) from pre-clinical phases through commercialization of drug substances and drug products. Our chemists, engineers, and scientists develop key technical and business solutions across the portfolio using their deep technical expertise to accelerate testing of the clinical hypothesis and overall drug development. SMDD delivers on these responsibilities by recognizing diverse talent and cultures are vital to bring the next generation of life changing medicines to patients. Our team is looking for a creative and energetic chemist with experience in chemistry, manufacturing and control (CMC) of oligonucleotides to participate in a wide range of activities. 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 RNAi therapeutics. Developing and working with external contract manufacturing organizations (CMOs) to support external oligonucleotide synthesis, tech transfer and campaign execution will be an important aspect of this role. Responsibilities Top candidates for this position will be expected to: <ul><li>Bring an extensive knowledge of oligonucleotide development to SMDD and use this expertise to grow internal capabilities through coaching, mentorship, and leadership.</li><li>Identify scientific projects/process improvements where solutions are developed through interactions with diverse talent across the larger organization.</li><li>Lead a cross-disciplinary team to evaluate and refine manufacturing routes, technologies, and practices to deliver RNAi portfolio.</li><li>Possess fluent knowledge in modern synthetic organic and nucleic acid chemistry methods with the aim to challenge existing methods, define new manufacturing technologies, and apply those to deliver a portfolio.</li><li>Demonstrate high learning agility regarding grasping and exploiting 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 rapidly evolving portfolio of RNAi assets.</li><li>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.</li><li>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.</li><li>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.</li><li>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.</li><li>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.</li><li>Identify, partner and develop external chemistry innovations to complement existing internal capabilities and incorporate these innovations across the portfolio of assets.</li><li>Embrace diversity of thought, background and experience to deliver innovative solutions. Possess strong communication (oral, written), organizational, and leadership skills.</li><li>Lead through ambiguity, welcome and rapidly adjust to change, and identify and drive superior methods to accomplish tasks. </li></ul>Basic Requirements <ul><li>PhD degree in a relevant scientific discipline with 5+ years of experience (synthesis, oligonucleotide experience, solid phase synthesis, CMC) </li></ul>OR <ul><li>MS degree with 8+ years of relevant experience (synthesis, oligonucleotide experience, solid phase synthesis, CMC) </li></ul>Additional Preferences <ul><li>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.</li><li>Experience in development / CMC including quality and regulatory interactions is expected.</li><li>Experience with technical transfer of processes into manufacturing operations.</li><li>Good interpersonal skills and a sustained tendency for collaboration.</li><li>Demonstrated initiative and appropriate risk taking.</li><li>Demonstrated technical proficiency and ability to create ideas for future work plans.</li><li>Strong technical skills to supply business value.</li><li>Knowledge and experience with management of a technical project.</li><li>Demonstrated leadership capabilities especially in a team environment.</li><li>Ability to prioritize multiple activities and handle ambiguity.</li><li>Ability to influence others to promote a positive work environment.</li><li>Demonstrated success in persuasion, influence and negotiation. </li></ul>Additional Information <ul><li>Travel: 0 to 10%</li><li>Position Location: Indianapolis, IN; Lilly Technology Center-North (LTC-N) </li></ul>Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. 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. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups. #WeAreLilly

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