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Lilly Analytical Chemistry Research Advisor - Synthetic Molecule Design and Development in Indianapolis, Indiana

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 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.

Synthetic Molecule Design and Development

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

At Lilly, Synthetic Molecule Design and Development (SMDD) is involved in key activities for the development of synthetic drug substances and drug products starting with pre-clinical phases through commercialization. Our scientists and engineers develop innovative technical and business solutions across a portfolio of projects using their deep technical expertise to accelerate testing of the clinical hypothesis and overall drug development. Through recognizing the value of a hardworking and culturally diverse workforce, SMDD delivers on these responsibilities and helps bring the next generation of life changing medicines to patients.

Our team is looking for experienced, creative, and energetic candidates to lead overall control strategy development, unit operation optimization and process optimization of synthetic drug candidates to support clinical trials, regulatory submission, and product commercialization. The position presents an opportunity to lead dynamic teams comprised mainly of process chemists, analytical chemists, formulation scientists, and engineers.

Responsibilities:

Top candidates for this position will be expected to:

  • Possess experience leading multiple drug substance and drug product teams through Common Technology Document (CTD) authoring, NDA submission, Pre-approval inspection (PAI) readiness of manufacturing sites, and Country-specific Response to Questions (RtQ) approaches leading to successful approvals

  • Possess deep understanding of the external global regulatory climate, emerging requirements, and the ability to address key CMC regulatory questions that enable clinical studies which support marketing authorization applications

  • Provide technical guidance for analytical methods validated and transferred within an external network. Ensure methods are technically sound, well developed and characterized, and safe. Execute technology transfer to CRO/CMO organizations and Lilly manufacturing.

  • Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas (e.g., chemistry, pharmaceutical sciences, PAT, and modeling and simulation); be able to use these techniques in order to bring value across a portfolio of small molecule, oligonucleotide, and synthetic peptide modalities

  • Supervise, mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing

  • Demonstrate the ability to lead (decisively in the presence of scientific uncertainty) and/or supervise a cross-disciplinary team to evaluate and refine technologies, and practices to deliver a challenging portfolio

  • Encourage team members to take initiative and accountability to achieve goals; draws out and encourages others to share knowledge

  • Plan and manage short term and long-term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.

  • Collaborate closely with organizations across Development and Manufacturing to execute and deliver material and information for clinical trials and regulatory submissions

  • Embrace diverse thought, background, and experience to deliver innovative solutions

  • Possess strong communication (oral, written), organizational, and leadership skills

  • Actively engage in the external environment and the ability to recognize and apply external innovation across the Lilly synthetic portfolio

Basic Qualifications:

  • Ph.D. in analytical chemistry or bioanalytical chemistry, or a related field with 10+ years of experience in the pharmaceutical industry

Additional Skills/Preferences:

  • Experience with technical transfer of analytical methods into manufacturing operations

  • Experience developing global regulatory strategies including authoring regulatory submissions, responding to regulatory questions, and/or registering products across global markets.

  • Experience within the pharmaceutical sector is desired; however, other relevant experience may meet expectations. Prior experience in the development of an active ingredient and associated formulated product is acceptable. Relevant industrial sectors include: agrochemicals, nutraceuticals, specialty chemicals, and personal care products.

  • Strong technical skills to supply business value

  • Creativity and ability to transform ideas into marketable products and processes

  • Knowledge and experience with management of a technical project

  • Demonstrated leadership capabilities especially in a team environment

  • Demonstrated ability to drive and accept change

  • Demonstrated success in persuasion, influence and negotiation

  • Good interpersonal skills and a sustained tendency for collaboration

  • Ability to prioritize multiple activities and manage ambiguity

  • Ability to influence others to promote a positive work environment

  • Demonstrated technical proficiency and ability to create ideas for future work plans

Additional Information:

  • Travel: 0 to 10%

  • Position Local: Indianapolis, IN; Lilly Technology Center-North (LTC-N)

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 ( LillyRecruitingCompliance@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.

As a condition of employment with Eli Lilly and Company in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

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