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.
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 upbeat 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, and engineers.
Top candidates for this position will be expected to:
- Lead 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 submissions
- Understand unit operation design, process modeling, process equipment selection, data rich experiments, PAT utilization in the laboratory and production facilities, and scale-up methodologies
- Aim to challenge existing methods and create and apply groundbreaking technology and novel platforms within a time constrained environment
- Collaborate with process chemists on modern synthetic organic chemistry methods, synthetic strategy, and synthetic route development
- Learn with agility, understand and exploit effective scientific concepts and methods across multiple fields (e.g., continuous processing, automated reaction engineering, PAT, and modeling and simulation), and utilize these techniques in order to bring value across a portfolio of small molecule, oligonucleotide, and synthetic peptide modalities
- Lead a cross-disciplinary team to evaluate and refine new manufacturing routes, manufacturing technologies, and practices to deliver an exciting portfolio
- Lead decisively in the presence of scientific uncertainty and translate hypotheses into action
- Encourage team members to take initiative, share knowledge, and be accountable to achieve goals
- Provide technical guidance in the scale-up and demonstration of new chemical processes in development and commercial scale equipment. Ensure processes are technically sound, well developed and characterized, and safe. Engage in technology transfer activities to CRO/CMO organizations and Lilly manufacturing.
- Design laboratory experimentation in support of process design, definition, optimization, and technology transfer objectives. Demonstrate the ability to generate process data and a fundamental understanding of the underlying physical processes. Utilize advancements in process analytical technology (PAT) and modeling platforms to understand and direct experimental protocols
- Plan and run short term and long-term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource allocation to deliver projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.
- Collaborate with internal and external manufacturing partners to develop robust chemical processes that are readily amenable to efficient drug substance manufacturing
- Collaborate closely with organizations outside SMDD such as Product Delivery, Project Management, Quality, Manufacturing, and Regulatory to execute and deliver material and information for clinical trials and regulatory submissions
- Embrace diverse thought, background, and experience to deliver creative solutions
- Supervise, mentor and develop scientific staff. Foster continued technical and professional growth of group members
- Actively engage in the external environment; to recognize and apply external innovation and across the Lilly synthetic portfolio
- Understand the external global regulatory climate and emerging requirements. Address key CMC regulatory questions that enable clinical studies which support marketing authorization applications
- Develop global regulatory strategies including authoring regulatory submissions, responding to regulatory questions, and/or registering products across global markets
- Ph.D. in chemical engineering or a related field
- Experience with developing chemical processes from proof of concept to product commercialization.
- Experience with technical transfer of processes into manufacturing operations
- Experience within the pharmaceutical sector is a plus; 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.
- Experience with modeling and simulation tools, data analytics, and predictive analytics
- Experience with online and offline analytical techniques and process analytical technologies (PAT)
- 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 inspire change
- Demonstrated success in persuasion, influence and negotiation
- Interpersonal skills and a sustained tendency for collaboration
- Ability to prioritize multiple activities and handle ambiguity
- Ability to influence others to promote a positive work environment
- Understanding and awareness of the external scientific and regulatory landscape
- Demonstrated initiative and risk-taking
- Demonstrated technical proficiency; to create ideas for future work plans
- Established external publication record
- 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 ( 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.
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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.