Director, Purification Process Development
Eli Lilly and Company
4 months ago
On-site
Indianapolis, IN
Operations
Top Candidates For This Position Will Be Expected To
- Work to design optimized downstream drug substance processes for new biosynthetic candidates; apply chromatography process development using first-principles + experimentation, strong process equipment knowledge, and scale-up methodologies; challenge existing methods and create/apply novel technologies/platforms.
- Demonstrate familiarity with peptides and oligonucleotide separations.
- Employ strategic thinking to overcome technical hurdles and oversee process technical transfer to GMP manufacturing facilities.
- Show high learning agility across disciplines; apply learnings to small molecule, oligonucleotide, and synthetic peptide modalities.
- Develop and deploy modern technologies including continuous processing, automated screening, PAT, and modeling/simulation.
- Interface across multiple projects to understand business needs; help build the purification engineering team to critical mass.
- Translate hypotheses into action amid scientific uncertainty.
- Supervise, mentor, and develop scientific staff; promote technical/professional growth and knowledge sharing.
- Encourage initiative and accountability; troubleshoot issues, identify trends, and reduce process variability.
- Provide technical guidance for scale-up and demonstration of new purification processes; participate in technology transfer to CRO/CMO and Lilly manufacturing.
- Design laboratory experimentation to support process design/definition/optimization and technology transfer; generate process/property data using underlying physical understanding; use PAT and modeling to direct experimental protocols.
- Plan/manage short- and long-term development activities; develop/review timelines and technical agendas; recommend resource allocation; communicate progress and propose changes.
- Collaborate with internal/external manufacturing partners to develop robust processes for efficient drug substance manufacturing.
- Collaborate with Project teams (Project Management, Quality, Manufacturing, Regulatory) to deliver material and information for clinical trials and regulatory submissions.
- Support CMC regulatory questions enabling clinical studies and marketing authorization.
Minimum Qualifications
- Ph.D. in chemical engineering/chemistry (5+ years) OR MS (10+ years) OR BS (12+ years)
- Experience within the pharmaceutical sector
- Experience developing purification processes from proof of concept through commercialization
- Experience with technical transfer of processes into manufacturing operations
Additional Skills/Preferences
- Experience authoring regulatory submissions and responding to regulatory questions
- Experience with multivariate analysis for process monitoring/troubleshooting at scale
- Travel: 0 to 10%
- Position location: Indianapolis, IN (Lilly Technology Center-North)
- Work to design optimized downstream drug substance processes for new biosynthetic candidates; apply chromatography process development using first-principles + experimentation, strong process equipment knowledge, and scale-up methodologies; challenge existing methods and create/apply novel technologies/platforms.
- Demonstrate familiarity with peptides and oligonucleotide separations.
- Employ strategic thinking to overcome technical hurdles and oversee process technical transfer to GMP manufacturing facilities.
- Show high learning agility across disciplines; apply learnings to small molecule, oligonucleotide, and synthetic peptide modalities.
- Develop and deploy modern technologies including continuous processing, automated screening, PAT, and modeling/simulation.
- Interface across multiple projects to understand business needs; help build the purification engineering team to critical mass.
- Translate hypotheses into action amid scientific uncertainty.
- Supervise, mentor, and develop scientific staff; promote technical/professional growth and knowledge sharing.
- Encourage initiative and accountability; troubleshoot issues, identify trends, and reduce process variability.
- Provide technical guidance for scale-up and demonstration of new purification processes; participate in technology transfer to CRO/CMO and Lilly manufacturing.
- Design laboratory experimentation to support process design/definition/optimization and technology transfer; generate process/property data using underlying physical understanding; use PAT and modeling to direct experimental protocols.
- Plan/manage short- and long-term development activities; develop/review timelines and technical agendas; recommend resource allocation; communicate progress and propose changes.
- Collaborate with internal/external manufacturing partners to develop robust processes for efficient drug substance manufacturing.
- Collaborate with Project teams (Project Management, Quality, Manufacturing, Regulatory) to deliver material and information for clinical trials and regulatory submissions.
- Support CMC regulatory questions enabling clinical studies and marketing authorization.
Minimum Qualifications
- Ph.D. in chemical engineering/chemistry (5+ years) OR MS (10+ years) OR BS (12+ years)
- Experience within the pharmaceutical sector
- Experience developing purification processes from proof of concept through commercialization
- Experience with technical transfer of processes into manufacturing operations
Additional Skills/Preferences
- Experience authoring regulatory submissions and responding to regulatory questions
- Experience with multivariate analysis for process monitoring/troubleshooting at scale
- Travel: 0 to 10%
- Position location: Indianapolis, IN (Lilly Technology Center-North)