Director Late Phase Process Development SMDD

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work, but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Synthetic Molecule Design and Development (SMDD) team is involved in key activities for the development of synthetic active pharmaceutical ingredients (API) from pre-clinical 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 that diverse talent and cultures are vital to bring the next generation of life-changing medicines to patients.

Position Summary:

Our team is looking for experienced and creative individuals to lead late-phase synthetic molecule process development. This includes finalizing the commercial route and process, characterizing the process, and defining the control strategy to support Phase 3 clinical supply, registration stability, regulatory submissions, process validation, and commercial hand-off.  The position presents an opportunity to lead dynamic teams comprised of process chemists, analytical chemists, material 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 in the utilization of modern synthetic organic and process chemistry techniques to address key CMC challenges

Lead and/or supervise the finalization of commercial synthetic routes and the development of robust, scalable, and well-characterized API manufacturing processes, including starting materials selection and justification of the commercial route

Design experimental laboratory plans in support of route and process design, definition, optimization, and technology transfer objectives

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 dynamic portfolio of small molecule programs

Possess solid understanding in unit operation design and scale-up methodologies; build and apply groundbreaking technology and novel platforms within a time constrained environment

Apply risk-based process characterization, design space definition, and control strategy development to ensure readiness for process validation and commercial manufacture.

Leverage predictive modeling, simulation, and machine learning to inform design space definition, impurity fate and purge, scale-up, and control strategy, reducing experimental burden and strengthening regulatory justification

Lead a cross-disciplinary team to refine manufacturing routes and manufacturing technologies to advance an exciting small molecule portfolio

Deliver commercial-ready manufacturing processes, including impurity control, process robustness, and lifecycle strategy, and enable effective handoff to internal and external commercial manufacturing sites

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

Integrate process and property data with a fundamental understanding of the underlying physical processes; build and apply mechanistic, kinetic, and data-driven models to predict process performance and guide development decisions

Utilize modern artificial intelligence and machine learning tools to accelerate development and deepen process understanding

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

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 demonstrate 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 8+ 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. Experience with developing chemical processes for Phase 3 through commercialization of small molecule projects.

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 applying Quality by Design (QbD) principles, design of experiments (DoE), and risk assessments to establish process understanding, proven acceptable ranges, and design space.

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.

Experience with modeling and simulation tools, data analytics, predictive analytics, and AI/ML

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 20%

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

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$153,000 - $264,000

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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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