Director, Analytical Chemistry Extended Characterization
Scorpion Therapeutics, Indianapolis, Indiana, us, 46262
Role Summary
Director, Analytical Chemistry Extended Characterization. Lead a team of scientists and associates to develop and implement analytical methods for extended characterization of RNA drug substances (gRNA and mRNA) and lipid nanoparticle (LNP) drug products in late-stage development. Partner with cross-functional teams within Lilly's Product Research & Development to move programs forward and support non-GMP testing for development studies. Location: Indianapolis, IN (Lilly Technology Center-North); Travel: 15-30% (initial 4-6 months travel to Verve Boston site required). Responsibilities
Lead a team of scientists working on mRNA, gRNA and LNP assays focused on biophysical extended characterization. Partner across the Analytical Development team and cross-functionally with BR&D and SMDD to lead, plan, and execute complex characterization studies; serve as the analytical lead in cross-functional interactions. Develop and implement methods intended for product characterization to support late stage and commercialization of gene editing programs. Provide technical expertise for the structural characterization of gRNAs, mRNAs and lipid nanoparticle (LNP) complexes. Serve as analytical lead for CMC project teams. Oversee troubleshooting, tech transfer, and phase-appropriate GMP validation of analytical methods at the internal Quality Control lab and at contract testing labs in collaboration with Quality team. Author and review technical reports and regulatory submissions. Provide guidance and support to team members, promoting their professional growth and development. Effectively manage multiple projects to ensure timely delivery. Foster a culture of lab safety, data integrity, collaboration, innovation, continuous improvement and accountability within the team. Other duties as assigned. Qualifications
Required: PhD in analytical chemistry or bioanalytical chemistry, or a related field with 10+ years of experience in the pharmaceutical industry Required: Prior laboratory operations and management experience leading a team of scientists and associates for analytical development in a clinical stage biotech environment. Required: Prior experience must include performing analytical assays to support the development of lead molecules, troubleshooting and optimizing analytical assays for GMP use per ICH guidelines. Required: Experience with planning and executing product and process development studies such as forced degradation, comparability assessments, stability, extended characterization, etc. Required: Experience with analytical control strategy implementation, and/or regulatory submissions related to advanced gene therapies. Required: Direct experience analyzing LNPs and RNA by biophysical techniques such as LC-MS, DSC, DLS, MALS, etc. Required: Demonstrated competency in operating HPLC/UPLC/LC-MS instrumentation. Required: Hands-on experience analyzing DNA/RNA by IP-RP, IEX, LC-fluor and multi-modal LC techniques required. Required: Conceptual understanding of solid phase oligonucleotide synthesis and purification strategies. Required: Experience with technical transfer of analytical methods into manufacturing operations. Required: Experience developing global regulatory strategies including authoring regulatory submissions, responding to regulatory questions, and/or registering products across global markets Required: Demonstrated success in persuasion, influence, and negotiation. Required: Good interpersonal skills and a sustained tendency for collaboration. Required: Ability to prioritize multiple activities and manage ambiguity. Required: Ability to influence others to promote a positive work environment. Required: Demonstrated technical proficiency and ability to create ideas for future work plans. Preferred: Knowledge/hands-on experience in oligonucleotide lipid nanoparticle delivery, production and purification of short and large oligonucleotides, protein engineering and process development are a plus, but not required. Additional Requirements
Travel: 15-30% (initial 4-6 months travel to Verve Boston site required) Potential exposure to chemicals, allergens, and loud noises.
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Director, Analytical Chemistry Extended Characterization. Lead a team of scientists and associates to develop and implement analytical methods for extended characterization of RNA drug substances (gRNA and mRNA) and lipid nanoparticle (LNP) drug products in late-stage development. Partner with cross-functional teams within Lilly's Product Research & Development to move programs forward and support non-GMP testing for development studies. Location: Indianapolis, IN (Lilly Technology Center-North); Travel: 15-30% (initial 4-6 months travel to Verve Boston site required). Responsibilities
Lead a team of scientists working on mRNA, gRNA and LNP assays focused on biophysical extended characterization. Partner across the Analytical Development team and cross-functionally with BR&D and SMDD to lead, plan, and execute complex characterization studies; serve as the analytical lead in cross-functional interactions. Develop and implement methods intended for product characterization to support late stage and commercialization of gene editing programs. Provide technical expertise for the structural characterization of gRNAs, mRNAs and lipid nanoparticle (LNP) complexes. Serve as analytical lead for CMC project teams. Oversee troubleshooting, tech transfer, and phase-appropriate GMP validation of analytical methods at the internal Quality Control lab and at contract testing labs in collaboration with Quality team. Author and review technical reports and regulatory submissions. Provide guidance and support to team members, promoting their professional growth and development. Effectively manage multiple projects to ensure timely delivery. Foster a culture of lab safety, data integrity, collaboration, innovation, continuous improvement and accountability within the team. Other duties as assigned. Qualifications
Required: PhD in analytical chemistry or bioanalytical chemistry, or a related field with 10+ years of experience in the pharmaceutical industry Required: Prior laboratory operations and management experience leading a team of scientists and associates for analytical development in a clinical stage biotech environment. Required: Prior experience must include performing analytical assays to support the development of lead molecules, troubleshooting and optimizing analytical assays for GMP use per ICH guidelines. Required: Experience with planning and executing product and process development studies such as forced degradation, comparability assessments, stability, extended characterization, etc. Required: Experience with analytical control strategy implementation, and/or regulatory submissions related to advanced gene therapies. Required: Direct experience analyzing LNPs and RNA by biophysical techniques such as LC-MS, DSC, DLS, MALS, etc. Required: Demonstrated competency in operating HPLC/UPLC/LC-MS instrumentation. Required: Hands-on experience analyzing DNA/RNA by IP-RP, IEX, LC-fluor and multi-modal LC techniques required. Required: Conceptual understanding of solid phase oligonucleotide synthesis and purification strategies. Required: Experience with technical transfer of analytical methods into manufacturing operations. Required: Experience developing global regulatory strategies including authoring regulatory submissions, responding to regulatory questions, and/or registering products across global markets Required: Demonstrated success in persuasion, influence, and negotiation. Required: Good interpersonal skills and a sustained tendency for collaboration. Required: Ability to prioritize multiple activities and manage ambiguity. Required: Ability to influence others to promote a positive work environment. Required: Demonstrated technical proficiency and ability to create ideas for future work plans. Preferred: Knowledge/hands-on experience in oligonucleotide lipid nanoparticle delivery, production and purification of short and large oligonucleotides, protein engineering and process development are a plus, but not required. Additional Requirements
Travel: 15-30% (initial 4-6 months travel to Verve Boston site required) Potential exposure to chemicals, allergens, and loud noises.
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