BioSpace
Advisor/Senior Advisor – Process Chemistry Peptides & Oligonucleotides
BioSpace, Indianapolis, Indiana, us, 46262
Overview
Advisor/Senior Advisor – Process Chemistry Peptides & Oligonucleotides 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 Synthetic Molecule Design and Development (SMDD) group develops synthetic drug substances and drug products from the pre-clinical phase through commercialization, including small molecules, synthetic peptides, oligonucleotides, and other emerging modalities. The SMDD team seeks candidates with experience in chemistry, manufacturing and controls (CMC) of peptides and oligonucleotides to support the portfolio across development and regulatory needs. The role involves leading CMC activities to support clinical trials and regulatory submissions, collaborating with internal teams and external CMOs for synthesis, tech transfer, and campaign execution.
Responsibilities
Synthesize complex peptide/oligonucleotide API(s) using established and advanced technologies in synthetic chemistry, chemical engineering, and continuous manufacturing.
Apply knowledge of modern synthetic organic, peptide, and nucleic acid chemistry to address CMC challenges and advance manufacturing technologies.
Learn rapidly across disciplines and apply new concepts to portfolios including small molecules, oligonucleotides, synthetic peptides, and related modalities.
Understand unit operation design, process modeling, equipment selection, and scale-up methodologies.
Provide technical leadership in scaling and demonstrating new processes in development scale; collaborate with internal and external partners to develop robust processes for drug substance manufacturing.
Collaborate with internal CMC networks to deliver material and information for clinical trials and regulatory submissions.
Design experimental plans for route and process design, optimization, and technology transfer.
Generate data for regulatory filings and address CMC regulatory questions to enable clinical studies.
Identify and partner with external chemistry innovations to complement internal capabilities.
Engage with external chemistry communities through presentations and publications to advance Lilly portfolio.
Lead through ambiguity, adapt to change, and drive improvements in methods.
Qualifications
PhD degree in a relevant scientific discipline with 2+ years of experience (synthesis, oligonucleotide/peptide experience, solid phase synthesis, CMC) OR MS degree with 5+ years of relevant experience.
Additional Skills/Preferences
Experience in the pharmaceutical sector and active ingredient development; experience with translating concepts to product commercialization.
Experience in development/CMC including quality and regulatory interactions; experience with tech transfer to manufacturing.
Strong collaboration, initiative, risk-taking, and technical leadership capabilities.
Ability to manage multiple activities, handle ambiguity, and influence others to foster a positive environment.
Demonstrated project management and leadership in a team setting.
Additional Information
Travel: 0 to 10%
Location: Indianapolis, IN; Lilly Technology Center-North (LTC-N)
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume, please submit the accommodation request form. Lilly is an EEO Employer and does not discriminate on protected characteristics. Our ERGs are open to all employees. Actual compensation will depend on education, experience, and location. The anticipated wage is $121,500 - $198,000, plus potential bonus and comprehensive benefits.
#WeAreLilly
#J-18808-Ljbffr
Advisor/Senior Advisor – Process Chemistry Peptides & Oligonucleotides 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 Synthetic Molecule Design and Development (SMDD) group develops synthetic drug substances and drug products from the pre-clinical phase through commercialization, including small molecules, synthetic peptides, oligonucleotides, and other emerging modalities. The SMDD team seeks candidates with experience in chemistry, manufacturing and controls (CMC) of peptides and oligonucleotides to support the portfolio across development and regulatory needs. The role involves leading CMC activities to support clinical trials and regulatory submissions, collaborating with internal teams and external CMOs for synthesis, tech transfer, and campaign execution.
Responsibilities
Synthesize complex peptide/oligonucleotide API(s) using established and advanced technologies in synthetic chemistry, chemical engineering, and continuous manufacturing.
Apply knowledge of modern synthetic organic, peptide, and nucleic acid chemistry to address CMC challenges and advance manufacturing technologies.
Learn rapidly across disciplines and apply new concepts to portfolios including small molecules, oligonucleotides, synthetic peptides, and related modalities.
Understand unit operation design, process modeling, equipment selection, and scale-up methodologies.
Provide technical leadership in scaling and demonstrating new processes in development scale; collaborate with internal and external partners to develop robust processes for drug substance manufacturing.
Collaborate with internal CMC networks to deliver material and information for clinical trials and regulatory submissions.
Design experimental plans for route and process design, optimization, and technology transfer.
Generate data for regulatory filings and address CMC regulatory questions to enable clinical studies.
Identify and partner with external chemistry innovations to complement internal capabilities.
Engage with external chemistry communities through presentations and publications to advance Lilly portfolio.
Lead through ambiguity, adapt to change, and drive improvements in methods.
Qualifications
PhD degree in a relevant scientific discipline with 2+ years of experience (synthesis, oligonucleotide/peptide experience, solid phase synthesis, CMC) OR MS degree with 5+ years of relevant experience.
Additional Skills/Preferences
Experience in the pharmaceutical sector and active ingredient development; experience with translating concepts to product commercialization.
Experience in development/CMC including quality and regulatory interactions; experience with tech transfer to manufacturing.
Strong collaboration, initiative, risk-taking, and technical leadership capabilities.
Ability to manage multiple activities, handle ambiguity, and influence others to foster a positive environment.
Demonstrated project management and leadership in a team setting.
Additional Information
Travel: 0 to 10%
Location: Indianapolis, IN; Lilly Technology Center-North (LTC-N)
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume, please submit the accommodation request form. Lilly is an EEO Employer and does not discriminate on protected characteristics. Our ERGs are open to all employees. Actual compensation will depend on education, experience, and location. The anticipated wage is $121,500 - $198,000, plus potential bonus and comprehensive benefits.
#WeAreLilly
#J-18808-Ljbffr