BioSpace
Advisor Research Scientist (Purification) - ADN RAMP Team
BioSpace, Indianapolis, Indiana, us, 46262
Advisor Research Scientist (Purification) – ADN RAMP Team
Overview
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. Base pay range: $123,750.00/yr - $198,000.00/yr Key Responsibilities
Lead the successful transfer of new molecules into production at Lilly Sites Leverage internal and external expertise to improve existing production processes focused on purification of peptides Establish a world class methodology to ensure new manufacturing processes are robust, cost effective and can be transitioned safely and rapidly into production Maintain a thorough understanding of the state of the art of manufacturing and regulatory requirements and build these into our processes Develop strong working relationships with both R&D and plant sites to ensure success Serves as a member of multidisciplinary product development teams responsible for the commercial scale development of new processes. He/she typically directs the laboratory activities and development of one or more junior staff members Participate in the Science Lead Team – part of scientific governance/oversight for Lilly sites. Provide technical oversight to the Post Launch Optimization Team (PLOT) and other relevant TS/MS technical projects. Be the technical steward on all products they are accountable for. Define and lead TS/MS technical projects (experimental, modelling and/or production data analysis) to improve process control, yield, purity and/or productivity. The Research Scientist/Senior Research Scientist should also have a proven track record in the following areas.
Demonstrated ability to commercialize and solve manufacturing problems. Hands on experience supporting production at different scales from both a commercialization and supply perspective. Proven track record of working with diverse groups across the value chain and in multiple locations Understanding the interaction of bulk drug substance and drug product formulation interaction of equipment set(s) with process (drug substance and drug product) Significant experience with registration, including authoring of technical reports, Development History Report, regulatory responses, or direct interactions with regulatory agencies.
Basic Requirements
BSc/MSc/PhD in Chemistry/Biochemistry or related science discipline. BSc requires 10+ years of industrial experience. MSc/PhD requires 5+ years of industrial experience. Deep technical interest and understanding in manufacturing operational excellence principles. Additional Skills/Preferences
Excellent verbal and written communications skills. Strong analytical and problem-solving skills. Collaborative skills with operations, automation, and other process team members. Ability to coach others. Ability to influence without authority. Ability to clarify and simplify complex issues. Strong trust building with peers and leaders. Willing to work off-shift hours as needed to support project milestones and training of new employees. Other Information
The ADN RAMP team will support multiple new API/Dry Products sites in various locations (US and OUS). Significant travel may be required to current startup sites in order to meet business needs, along with potential short-term assignments across the network (can include international relocations). Candidates must be mobile and flexible. Lilly is proud to be an EEO Employer and 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. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $123,750 - $198,000. Full-time employees are eligible for a company bonus (depending on company and individual performance). Lilly offers a comprehensive benefits program including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
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Overview
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. Base pay range: $123,750.00/yr - $198,000.00/yr Key Responsibilities
Lead the successful transfer of new molecules into production at Lilly Sites Leverage internal and external expertise to improve existing production processes focused on purification of peptides Establish a world class methodology to ensure new manufacturing processes are robust, cost effective and can be transitioned safely and rapidly into production Maintain a thorough understanding of the state of the art of manufacturing and regulatory requirements and build these into our processes Develop strong working relationships with both R&D and plant sites to ensure success Serves as a member of multidisciplinary product development teams responsible for the commercial scale development of new processes. He/she typically directs the laboratory activities and development of one or more junior staff members Participate in the Science Lead Team – part of scientific governance/oversight for Lilly sites. Provide technical oversight to the Post Launch Optimization Team (PLOT) and other relevant TS/MS technical projects. Be the technical steward on all products they are accountable for. Define and lead TS/MS technical projects (experimental, modelling and/or production data analysis) to improve process control, yield, purity and/or productivity. The Research Scientist/Senior Research Scientist should also have a proven track record in the following areas.
Demonstrated ability to commercialize and solve manufacturing problems. Hands on experience supporting production at different scales from both a commercialization and supply perspective. Proven track record of working with diverse groups across the value chain and in multiple locations Understanding the interaction of bulk drug substance and drug product formulation interaction of equipment set(s) with process (drug substance and drug product) Significant experience with registration, including authoring of technical reports, Development History Report, regulatory responses, or direct interactions with regulatory agencies.
Basic Requirements
BSc/MSc/PhD in Chemistry/Biochemistry or related science discipline. BSc requires 10+ years of industrial experience. MSc/PhD requires 5+ years of industrial experience. Deep technical interest and understanding in manufacturing operational excellence principles. Additional Skills/Preferences
Excellent verbal and written communications skills. Strong analytical and problem-solving skills. Collaborative skills with operations, automation, and other process team members. Ability to coach others. Ability to influence without authority. Ability to clarify and simplify complex issues. Strong trust building with peers and leaders. Willing to work off-shift hours as needed to support project milestones and training of new employees. Other Information
The ADN RAMP team will support multiple new API/Dry Products sites in various locations (US and OUS). Significant travel may be required to current startup sites in order to meet business needs, along with potential short-term assignments across the network (can include international relocations). Candidates must be mobile and flexible. Lilly is proud to be an EEO Employer and 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. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $123,750 - $198,000. Full-time employees are eligible for a company bonus (depending on company and individual performance). Lilly offers a comprehensive benefits program including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
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