Lilly
Director/Sr Director/Executive Director Central TSMS for Oligonucleotides
Lilly, Tulsa, Oklahoma, United States, 74145
Lilly Director/Sr Director/Executive Director Central TSMS for Oligonucleotides Indianapolis, Indiana Apply Now
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 around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.Company OverviewLilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Founded over 145 years ago, the company has sustained a culture that values excellence, integrity, and respect for people.Job DescriptionJoin the energetic and growing Active Pharmaceutical Ingredient -Technical Services Manufacturing Science Central Team that delivers a diverse portfolio of drug substances essential to Lilly! As our portfolio is expanding, we have exciting new positions available in the development of our new oligonucleotide manufacturing platform.The Central API TSMS Director/Executive Director will provide technical and scientific expertise within a dynamic and growing team that is supporting delivery of commercialization efforts including technical transfers, process validations, and process optimization for the oligonucleotide portfolio. The successful candidate will oversee technical aspects of the development of API manufacturing, including technical depth of understanding of unit operations, technical transfers, and process validation strategy.Responsibilities:Become Network Subject Matter Expert in oligonucleotide API synthesis to support growing portfolio of products.Develop critical relationships with Lilly’s Development Organization in the establishment of synthetic approaches to oligonucleotides with innovative solutions for commercial transfer.Establish depth of understanding of control strategy (CS) of molecules and translate this control strategy into unit operation requirements.Lead resolution of technical issues including those related to control strategy and operational challenges.Employ excellent communication skills to manage internal and external relationships.Ensure proper characterization of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, and specifications.Drive or support initial technology transfers of the oligonucleotide pipeline assets into commercial scale facilities.Work closely with Development and Global Regulatory teams to author/review regulatory submission documents.Ensure that processes are compliant, capable, in control, and maintained in a validated state.Influence and implement the network technical agenda and drive continuous improvement.Basic Requirements:MSc/Ph.D. in scientific disciplines of Biochemistry, Chemistry, Chemical Engineering, or related fields with min 5 yrs experience, or equivalent overall industry experience (10 years +).Demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.Oligonucleotide experience preferred.Proven experience at leading post-launch technical agendas and delivering projects that have driven substantial step changes in manufacturing.Qualified candidates must be legally authorized to be employed in the United States.Additional Information:Occasional travel required 5 – 10%.LOCATION:Indianapolis, INLilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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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 around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.Company OverviewLilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Founded over 145 years ago, the company has sustained a culture that values excellence, integrity, and respect for people.Job DescriptionJoin the energetic and growing Active Pharmaceutical Ingredient -Technical Services Manufacturing Science Central Team that delivers a diverse portfolio of drug substances essential to Lilly! As our portfolio is expanding, we have exciting new positions available in the development of our new oligonucleotide manufacturing platform.The Central API TSMS Director/Executive Director will provide technical and scientific expertise within a dynamic and growing team that is supporting delivery of commercialization efforts including technical transfers, process validations, and process optimization for the oligonucleotide portfolio. The successful candidate will oversee technical aspects of the development of API manufacturing, including technical depth of understanding of unit operations, technical transfers, and process validation strategy.Responsibilities:Become Network Subject Matter Expert in oligonucleotide API synthesis to support growing portfolio of products.Develop critical relationships with Lilly’s Development Organization in the establishment of synthetic approaches to oligonucleotides with innovative solutions for commercial transfer.Establish depth of understanding of control strategy (CS) of molecules and translate this control strategy into unit operation requirements.Lead resolution of technical issues including those related to control strategy and operational challenges.Employ excellent communication skills to manage internal and external relationships.Ensure proper characterization of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, and specifications.Drive or support initial technology transfers of the oligonucleotide pipeline assets into commercial scale facilities.Work closely with Development and Global Regulatory teams to author/review regulatory submission documents.Ensure that processes are compliant, capable, in control, and maintained in a validated state.Influence and implement the network technical agenda and drive continuous improvement.Basic Requirements:MSc/Ph.D. in scientific disciplines of Biochemistry, Chemistry, Chemical Engineering, or related fields with min 5 yrs experience, or equivalent overall industry experience (10 years +).Demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.Oligonucleotide experience preferred.Proven experience at leading post-launch technical agendas and delivering projects that have driven substantial step changes in manufacturing.Qualified candidates must be legally authorized to be employed in the United States.Additional Information:Occasional travel required 5 – 10%.LOCATION:Indianapolis, INLilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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