BioSpace
Senior Research Director, Analytical Chemistry - Synthetic Molecule Design and D
BioSpace, Indianapolis, Indiana, us, 46262
Overview
Senior Research Director, Analytical Chemistry - Synthetic Molecule Design and Development (SMDD). The Senior Research Director, Analytical Chemistry, will be responsible for the technical leadership and execution of analytical efforts for the commercial development of drug substance and/or drug product processes. This role supports clinical trials, regulatory submissions, and new product commercialization within Lilly's SMDD organization, which develops synthetic drug substances and drug products from the pre-clinical phase through commercialization. Location: Indianapolis, IN. Travel: 0 to 10%. Responsibilities
Drive implementation of technical solutions and analytical strategies to enable drug substance process or drug product formulation development. Collaborate with project development teams, regulatory scientists, and manufacturing partners to deliver robust control strategies for drug substances, drug products, and/or drug product intermediates (e.g., spray-dried dispersions). Apply experience authoring IND/CTA, NDA/MAA, and country-specific responses to questions and/or registering products across global markets. Provide technical guidance for analytical activities within an external network. Ensure methods are technically sound, well developed, and fit for purpose. Execute technology transfer to CRO/CMO organizations and Lilly manufacturing sites. Demonstrate learning agility and cross-disciplinary understanding across chemistry, pharmaceutical sciences, PAT, and modeling/simulation. Mentor and develop scientific staff; support continued technical and professional growth and knowledge sharing. Plan and manage short- and long-term development activities. Develop and review technical agendas and timelines for project work. Allocate resources to meet plans and communicate progress, proposing changes as needed. Collaborate with development and manufacturing organizations to deliver material and information for clinical trials and regulatory submissions. Welcome varied perspectives to create new solutions and actively engage with the external environment to apply external innovation to Lilly's synthetic portfolio. Basic Requirements
Ph.D. in analytical chemistry or bioanalytical chemistry, or a related field 8+ years’ experience in a pharmaceutical industry setting with focus on small molecules, synthetic peptides, or oligonucleotides Demonstrated expertise leading analytical efforts in pharmaceutical product development and commercialization. Proven skills developing, validating, and transferring analytical methods, authoring regulatory documentation, and overseeing CMO/CRO activities Strong communication (oral, written), organizational, and leadership skills Additional Preferences
Experience with product commercialization, including technical transfer of analytical methods into manufacturing operations Ability to drive and adapt to change Interpersonal skills and collaboration across teams Experience in persuasion, influence, and negotiation Additional Information
Travel: 0 to 10% Position Location: On-site, Indianapolis, IN; Lilly Technology Center-North (LTC-N) Compensation: $144,000 - $250,800; Full-time benefits including 401(k), health/dental/vision, and well-being programs Equal Opportunity
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce and is an EEO Employer. If you require accommodation to submit a resume, please complete the accommodation request form. Lilly 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.
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Senior Research Director, Analytical Chemistry - Synthetic Molecule Design and Development (SMDD). The Senior Research Director, Analytical Chemistry, will be responsible for the technical leadership and execution of analytical efforts for the commercial development of drug substance and/or drug product processes. This role supports clinical trials, regulatory submissions, and new product commercialization within Lilly's SMDD organization, which develops synthetic drug substances and drug products from the pre-clinical phase through commercialization. Location: Indianapolis, IN. Travel: 0 to 10%. Responsibilities
Drive implementation of technical solutions and analytical strategies to enable drug substance process or drug product formulation development. Collaborate with project development teams, regulatory scientists, and manufacturing partners to deliver robust control strategies for drug substances, drug products, and/or drug product intermediates (e.g., spray-dried dispersions). Apply experience authoring IND/CTA, NDA/MAA, and country-specific responses to questions and/or registering products across global markets. Provide technical guidance for analytical activities within an external network. Ensure methods are technically sound, well developed, and fit for purpose. Execute technology transfer to CRO/CMO organizations and Lilly manufacturing sites. Demonstrate learning agility and cross-disciplinary understanding across chemistry, pharmaceutical sciences, PAT, and modeling/simulation. Mentor and develop scientific staff; support continued technical and professional growth and knowledge sharing. Plan and manage short- and long-term development activities. Develop and review technical agendas and timelines for project work. Allocate resources to meet plans and communicate progress, proposing changes as needed. Collaborate with development and manufacturing organizations to deliver material and information for clinical trials and regulatory submissions. Welcome varied perspectives to create new solutions and actively engage with the external environment to apply external innovation to Lilly's synthetic portfolio. Basic Requirements
Ph.D. in analytical chemistry or bioanalytical chemistry, or a related field 8+ years’ experience in a pharmaceutical industry setting with focus on small molecules, synthetic peptides, or oligonucleotides Demonstrated expertise leading analytical efforts in pharmaceutical product development and commercialization. Proven skills developing, validating, and transferring analytical methods, authoring regulatory documentation, and overseeing CMO/CRO activities Strong communication (oral, written), organizational, and leadership skills Additional Preferences
Experience with product commercialization, including technical transfer of analytical methods into manufacturing operations Ability to drive and adapt to change Interpersonal skills and collaboration across teams Experience in persuasion, influence, and negotiation Additional Information
Travel: 0 to 10% Position Location: On-site, Indianapolis, IN; Lilly Technology Center-North (LTC-N) Compensation: $144,000 - $250,800; Full-time benefits including 401(k), health/dental/vision, and well-being programs Equal Opportunity
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce and is an EEO Employer. If you require accommodation to submit a resume, please complete the accommodation request form. Lilly 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.
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