Sr. Director, Process Chemistry
Eli Lilly and Company
4 months ago
Remote friendly (Indianapolis, IN)
United States
Operations
Position Summary
Lead synthetic molecule route commercialization, including process optimization and unit operation definition for drug candidates supporting clinical trials, product commercialization, and regulatory submissions. Lead cross-disciplinary teams (process chemists, analytical chemists, formulation scientists, engineers) and provide oversight for external R&D, tech transfer, and campaign execution.
Responsibilities
- Use modern synthetic organic and process chemistry techniques to address key CMC challenges
- Lead and/or supervise design and development of new API synthetic routes using modern technologies
- Apply new scientific concepts/methods across modalities (small molecule, oligonucleotide, synthetic peptide, and emerging synthetic modalities)
- Apply unit operation design, process modeling, process equipment selection, and scale-up methodologies
- Lead cross-disciplinary teams to evaluate/refine manufacturing routes, technologies, and practices
- Provide technical leadership in scale-up and demonstration of new chemical processes for development and commercial equipment
- Collaborate on technology transfer to CRO/CMO organizations and internal manufacturing nodes to ensure processes are robust, well developed/characterized, and safe
- Design experimental lab plans for route/process design, definition, optimization, and technology transfer objectives
- Integrate process (and property design) data using knowledge of underlying physical processes
- Apply PAT and modeling platforms to lead experimental protocols; leverage high-throughput platforms to accelerate reaction discovery
- Plan and lead short-/long-term development activities; develop/review technical agendas and timelines; advise on resource allocation; communicate progress and propose changes
- Collaborate across internal CMC networks (Drug Product Delivery, Project Management, Quality, Manufacturing, Regulatory) to deliver material and information for clinical trials and regulatory submissions
- Address key CMC regulatory questions aligned to global regulatory climate and emerging requirements
- Supervise, mentor, and develop a diverse scientific staff; encourage initiative and knowledge-sharing
- Collaborate with and integrate external scientific innovation across the synthetic portfolio
Minimum Qualifications
- Ph.D. in organic chemistry (or related field) with 10+ years of pharmaceutical process development experience, OR
- MS in Organic Chemistry (or related field) with 15+ years of experience
Additional Skills/Preferences
- Pharmaceutical sector experience preferred; acceptable alternatives include agrochemicals, nutraceuticals, specialty chemicals, personal care products
- Experience in active ingredient development through associated formulated products
- Experience developing chemical processes from proof of concept/mid-development through commercialization
- Experience with technical transfer into manufacturing operations
- Experience authoring regulatory submissions and responding to regulatory questions
- Strong publication record and external reputation
- Experience managing technical projects and building future work plans
- Experience with modern analytical techniques and PAT
- Experience with modeling/simulation tools, data analytics, and predictive analytics
- Ability to transform ideas into marketable products/processes
- Leadership, communication, collaboration, ability to prioritize multiple activities, handle ambiguity, and influence others
Additional Information
- Potential exposure to chemicals, allergens, and loud noises
- Travel: 0–10%
- Location: Indianapolis, IN; Lilly Technology Center-North (LTC-N)
Benefits (if applicable)
- Eligible for company bonus (for full-time equivalent employees, depending on company and individual performance)
- Comprehensive benefit program (e.g., 401(k), pension, vacation, medical/dental/vision/prescription drug, flexible benefits, life insurance, time off/leave of absence, well-being benefits)
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
Lead synthetic molecule route commercialization, including process optimization and unit operation definition for drug candidates supporting clinical trials, product commercialization, and regulatory submissions. Lead cross-disciplinary teams (process chemists, analytical chemists, formulation scientists, engineers) and provide oversight for external R&D, tech transfer, and campaign execution.
Responsibilities
- Use modern synthetic organic and process chemistry techniques to address key CMC challenges
- Lead and/or supervise design and development of new API synthetic routes using modern technologies
- Apply new scientific concepts/methods across modalities (small molecule, oligonucleotide, synthetic peptide, and emerging synthetic modalities)
- Apply unit operation design, process modeling, process equipment selection, and scale-up methodologies
- Lead cross-disciplinary teams to evaluate/refine manufacturing routes, technologies, and practices
- Provide technical leadership in scale-up and demonstration of new chemical processes for development and commercial equipment
- Collaborate on technology transfer to CRO/CMO organizations and internal manufacturing nodes to ensure processes are robust, well developed/characterized, and safe
- Design experimental lab plans for route/process design, definition, optimization, and technology transfer objectives
- Integrate process (and property design) data using knowledge of underlying physical processes
- Apply PAT and modeling platforms to lead experimental protocols; leverage high-throughput platforms to accelerate reaction discovery
- Plan and lead short-/long-term development activities; develop/review technical agendas and timelines; advise on resource allocation; communicate progress and propose changes
- Collaborate across internal CMC networks (Drug Product Delivery, Project Management, Quality, Manufacturing, Regulatory) to deliver material and information for clinical trials and regulatory submissions
- Address key CMC regulatory questions aligned to global regulatory climate and emerging requirements
- Supervise, mentor, and develop a diverse scientific staff; encourage initiative and knowledge-sharing
- Collaborate with and integrate external scientific innovation across the synthetic portfolio
Minimum Qualifications
- Ph.D. in organic chemistry (or related field) with 10+ years of pharmaceutical process development experience, OR
- MS in Organic Chemistry (or related field) with 15+ years of experience
Additional Skills/Preferences
- Pharmaceutical sector experience preferred; acceptable alternatives include agrochemicals, nutraceuticals, specialty chemicals, personal care products
- Experience in active ingredient development through associated formulated products
- Experience developing chemical processes from proof of concept/mid-development through commercialization
- Experience with technical transfer into manufacturing operations
- Experience authoring regulatory submissions and responding to regulatory questions
- Strong publication record and external reputation
- Experience managing technical projects and building future work plans
- Experience with modern analytical techniques and PAT
- Experience with modeling/simulation tools, data analytics, and predictive analytics
- Ability to transform ideas into marketable products/processes
- Leadership, communication, collaboration, ability to prioritize multiple activities, handle ambiguity, and influence others
Additional Information
- Potential exposure to chemicals, allergens, and loud noises
- Travel: 0–10%
- Location: Indianapolis, IN; Lilly Technology Center-North (LTC-N)
Benefits (if applicable)
- Eligible for company bonus (for full-time equivalent employees, depending on company and individual performance)
- Comprehensive benefit program (e.g., 401(k), pension, vacation, medical/dental/vision/prescription drug, flexible benefits, life insurance, time off/leave of absence, well-being benefits)
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation