Director/Sr. Director/Executive Director – Process Chemistry (SMDD)

Industry:

Company: Eli Lilly and Company

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 experienced and creative individuals to lead synthetic molecule route commercialization as well as process optimization and unit operation definition of drug candidates to support clinical trials, product commercialization, and regulatory submissions. The position presents an opportunity to lead dynamic teams comprised of process chemists, analytical chemists, formulation scientists, and engineers. Additionally, candidates will provide oversight for external R&D, tech transfer, and campaign execution.

Responsibilities

• Demonstrate a deep expertise and demonstrated capability with utilization of modern synthetic organic and process chemistry techniques to address key CMC challenges
• Lead and/or supervise the design and development of new synthetic routes for the manufacture of API using the most modern technologies
• Exhibit a high learning agility with the ability to understand and exploit new scientific concepts and methods across multiple fields; be able to apply these takeaways 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; build and apply groundbreaking technology and novel platforms within a time constrained environment
• Lead a cross-disciplinary team to evaluate and refine new manufacturing routes, manufacturing technologies, and practices to deliver an exciting portfolio
• Provide technical leadership in the scale-up and demonstration of new chemical processes in development and commercial scale equipment; collaborate in technology transfer activities to CRO/CMO organizations and internal Lilly manufacturing nodes to ensure processes are technically robust, well developed and characterized, and safe
• Design experimental laboratory plans in support of route and process design, definition, optimization, and technology transfer objectives.
• Ability to integrate process (and property design) data based on a fundamental understanding of the underlying physical processes
• Apply advancements in technology (PAT) and modeling platforms to understand and lead experimental protocols. Leverage high throughput experimental platforms to accelerate reaction discovery.
• Plan and lead short term and long-term development activities; develop and/or review technical agendas and timelines for project work; advise resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.
• 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.
• 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
• Embrace diversity in thoughts, background, and experiences through supervision, mentoring, and development of a diverse scientific staff 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
• Actively collaborate and exhibit influence in the external scientific environment and demonstrates an ability to recognize and integrate external innovation across the Lilly synthetic portfolio

Minimum Qualifications:

• Ph.D. in organic chemistry, or a related field with 10+ years of pharmaceutical process development experience OR MS in Organic Chemistry or related field with 15+ years’ experience.

Additional Skills/Preferences:

• Experience within the pharmaceutical sector is preferred; however, other experience may meet expectations. Prior experience in active ingredient development and associated formulated product is acceptable. Relevant industrial sectors would include agrochemicals, nutraceuticals, specialty chemicals, and personal care products. Experience with developing chemical processes from mid-development cycle (proof of concept) to product commercialization.
• Experience with technical transfer of processes into manufacturing operations
• Experience with authoring regulatory submissions and responding to regulatory questions
• Established external reputation and strong publication record
• Knowledge and experience with management of a technical project and ability to build ideas for future work plans
• Experience with modern analytical techniques and process analytical technologies (PAT)
• Experience with modeling and simulation tools, data analytics, and predictive analytics
• Ability to transform ideas into marketable products and processes
• Demonstrated leadership capabilities, good communication 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

Additional Information:

• Potential exposure to chemicals, allergens, and loud noises.
• Travel: 0 to 10%
• Position Location: Indianapolis, IN; Lilly Technology Center-North (LTC-N)

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