Director Early Phase Process Development SMDD

Biopharma Asia; Indianapolis (IN); On-site; USD 153,000 - 264,000; Full time

Benefits offered by this job

401(k) matching

Pension

Vacation benefits

Well-being benefits

Life insurance

Job summary

Lilly is seeking an experienced scientist to lead synthetic molecule route development and unit operation design for API candidates, supporting preclinical through Phase 2. You will supervise chemists, engineers, and technicians, coordinate tech transfer, and influence external CRO/CMO collaborations to ensure robust, scalable processes.

The role emphasizes leadership, collaboration, and delivering solutions within a fast-paced pharmaceutical environment with external partnerships and regulatory

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.
• Experience in pharmaceutical process development and active ingredient development is preferred.
• Experience with technical transfer of processes into manufacturing operations and regulatory submissions.
• Established external reputation with publications and leadership in a research environment.

Responsibilities

• Demonstrate deep expertise in modern synthetic organic and process chemistry to address CMC challenges.
• Lead/design new synthetic routes for API manufacturing using modern technologies.
• Plan laboratory experiments to support route/process design and technology transfer
• Guide cross-disciplinary teams and oversee external R&D and CRO/CMO collaborations
• Collaborate with internal networks to provide data for clinical trials and regulatory submissions
• Mentor and develop a diverse scientific staff and promote collaboration across teams

Skills

Leadership

Communication

Collaboration

Mentoring

Project management

Education

PhD in Organic Chemistry

MS in Organic Chemistry

Tools

PAT (process analytical technologies)

Job description

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 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.

Position Summary:

Our team is looking for experienced and creative individuals to lead synthetic molecule route development as well as unit operation definition of drug candidates to support preclinical studies through Phase 2 enabling studies and regulatory submissions. 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 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

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 portfolio of small molecule candidates.

Possess solid understanding in unit operation design 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

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

Ability to integrate process (and property design) data based on a fundamental understanding of the underlying physical processes

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 pre-clinical to Phase 3 enabling 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)

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.

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)

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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