BioSpace
Director - Engineering - Synthetic Molecule Design and Development (SMDD)
BioSpace, Indianapolis, Indiana, us, 46262
Director - Engineering - Synthetic Molecule Design and Development (SMDD)
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 employees work to discover and bring life-changing medicines to patients, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We put people first and seek individuals determined to make life better for people around the world. SMDD is involved in key activities for the development of synthetic active pharmaceutical ingredients from pre-clinical phases through commercialization. Our scientists and engineers develop technical and business solutions across the portfolio to accelerate testing of clinical hypotheses and overall drug development. We recognize that diverse talent and cultures are necessary to bring the next generation of life-changing medicines to patients. We are looking for experienced, creative, and energetic candidates to lead unit operation development and process optimization of synthetic drug candidates to support clinical trials, regulatory submissions, and product commercialization. This role offers the opportunity to lead dynamic teams comprised of process chemists, analytical chemists, formulation scientists, and engineers. Minimum Qualifications Ph.D. in chemical engineering or a closely related field with 8+ years of experience; or Master’s degree with 15+ years of experience. Experience with developing chemical processes from mid-development (proof of concept) to product commercialization. Experience with technical transfer of processes into manufacturing operations. Responsibilities and Requirements Possess fluent knowledge in unit operation design, process modeling, process equipment selection, and scale-up methodologies; drive to challenge existing methods; create and apply cutting-edge technology and novel platforms within a time-constrained environment. Familiarity with modern synthetic organic chemistry. Demonstrate high learning agility to understand and exploit new concepts across multiple disciplines; apply learnings to a portfolio of small molecule, oligonucleotide, and synthetic peptide modalities. Lead and/or supervise the design and development of new synthetic routes for API manufacture using modern technologies, including continuous processing, automated reaction screening, PAT, and modeling/simulation. Lead cross-disciplinary teams to evaluate and refine manufacturing routes and practices to deliver a challenging portfolio. Translate hypotheses into action in the face of scientific uncertainty; encourage initiative and accountability within the team. Provide technical guidance in scale-up and demonstration of new chemical processes in development and commercial-scale equipment; participate in technology transfer to CRO/CMO and Lilly manufacturing to ensure processes are sound, well-developed, characterized, and safe. Design laboratory experiments to support process design, definition, optimization, and technology transfer; generate process and property data from fundamental understanding; leverage PAT and modeling platforms to direct experiments. Plan and manage short-term and long-term development activities; develop technical agendas and timelines; allocate resources and communicate progress, proposing adjustments as needed. Collaborate with internal and external manufacturing partners to develop robust chemical processes amenable to efficient drug substance manufacturing. Work closely with Product Delivery, Project Management, Quality, Manufacturing, and Regulatory teams to support clinical trials and regulatory submissions. Embrace diverse thought and experience to deliver innovative solutions; demonstrate strong communication, organizational, and leadership skills. Supervise, mentor, and develop scientific staff; promote continued technical and professional growth and knowledge sharing. Engage with external innovation and apply insights across Lilly’s synthetic portfolio; maintain awareness of the external regulatory climate and emerging requirements; address key CMC regulatory questions to enable clinical studies and marketing authorization. Additional Information Travel: 0 - 10% Location: Indianapolis, IN; Lilly Technology Center-North (LTC-N) Lilly is an equal opportunity employer. If you require accommodations during the application process, please submit an accommodation request. Lilly is committed to creating a diverse and inclusive workplace. Actual compensation will depend on education, experience, skills, and location; anticipated wage range for this role is $142,500 - $253,000, with eligibility for a company bonus and comprehensive benefits.
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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 employees work to discover and bring life-changing medicines to patients, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We put people first and seek individuals determined to make life better for people around the world. SMDD is involved in key activities for the development of synthetic active pharmaceutical ingredients from pre-clinical phases through commercialization. Our scientists and engineers develop technical and business solutions across the portfolio to accelerate testing of clinical hypotheses and overall drug development. We recognize that diverse talent and cultures are necessary to bring the next generation of life-changing medicines to patients. We are looking for experienced, creative, and energetic candidates to lead unit operation development and process optimization of synthetic drug candidates to support clinical trials, regulatory submissions, and product commercialization. This role offers the opportunity to lead dynamic teams comprised of process chemists, analytical chemists, formulation scientists, and engineers. Minimum Qualifications Ph.D. in chemical engineering or a closely related field with 8+ years of experience; or Master’s degree with 15+ years of experience. Experience with developing chemical processes from mid-development (proof of concept) to product commercialization. Experience with technical transfer of processes into manufacturing operations. Responsibilities and Requirements Possess fluent knowledge in unit operation design, process modeling, process equipment selection, and scale-up methodologies; drive to challenge existing methods; create and apply cutting-edge technology and novel platforms within a time-constrained environment. Familiarity with modern synthetic organic chemistry. Demonstrate high learning agility to understand and exploit new concepts across multiple disciplines; apply learnings to a portfolio of small molecule, oligonucleotide, and synthetic peptide modalities. Lead and/or supervise the design and development of new synthetic routes for API manufacture using modern technologies, including continuous processing, automated reaction screening, PAT, and modeling/simulation. Lead cross-disciplinary teams to evaluate and refine manufacturing routes and practices to deliver a challenging portfolio. Translate hypotheses into action in the face of scientific uncertainty; encourage initiative and accountability within the team. Provide technical guidance in scale-up and demonstration of new chemical processes in development and commercial-scale equipment; participate in technology transfer to CRO/CMO and Lilly manufacturing to ensure processes are sound, well-developed, characterized, and safe. Design laboratory experiments to support process design, definition, optimization, and technology transfer; generate process and property data from fundamental understanding; leverage PAT and modeling platforms to direct experiments. Plan and manage short-term and long-term development activities; develop technical agendas and timelines; allocate resources and communicate progress, proposing adjustments as needed. Collaborate with internal and external manufacturing partners to develop robust chemical processes amenable to efficient drug substance manufacturing. Work closely with Product Delivery, Project Management, Quality, Manufacturing, and Regulatory teams to support clinical trials and regulatory submissions. Embrace diverse thought and experience to deliver innovative solutions; demonstrate strong communication, organizational, and leadership skills. Supervise, mentor, and develop scientific staff; promote continued technical and professional growth and knowledge sharing. Engage with external innovation and apply insights across Lilly’s synthetic portfolio; maintain awareness of the external regulatory climate and emerging requirements; address key CMC regulatory questions to enable clinical studies and marketing authorization. Additional Information Travel: 0 - 10% Location: Indianapolis, IN; Lilly Technology Center-North (LTC-N) Lilly is an equal opportunity employer. If you require accommodations during the application process, please submit an accommodation request. Lilly is committed to creating a diverse and inclusive workplace. Actual compensation will depend on education, experience, skills, and location; anticipated wage range for this role is $142,500 - $253,000, with eligibility for a company bonus and comprehensive benefits.
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