Research Advisor, Drug Product - SMDD
Eli Lilly and Company, Indianapolis, IN, United States
Responsibilities
Apply drug delivery fundamentals towards designing and optimizing phase appropriate drug products and processes from pre-FHD through commercialization for synthetic molecules.
Predict and assess the in vivo performance of drug molecules and formulations in preclinical species and humans using molecular properties and preclinical data. Leverage modeling to guide the development of preclinical and clinical formulations to enable the delivery of a broad range of synthetic molecules.
Refine clinical drug product prototypes, identify and mitigate technical risks to enable commercial products.
Collaborate and communicate project specific challenges and opportunities with key partners to plan and manage short/long term development activities aligned with the global CMC strategy.
Engage and influence internal and external scientific communities. Develop collaborations to solve technical challenges, identify and implement novel drug delivery and manufacturing technologies, influence clinical study design to benefit our patients.
Author and review high quality technical reports, peer reviewed publications, and regulatory documentation to support new technologies and/or regulatory submissions.
Basic Requirements
Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Material Science, or other related fields.
M.S. with 6+ years of demonstrated equivalent experience in a related field of expertise.
B.S. with 10+ years of demonstrated equivalent experience in a related field of expertise.
Additional Skills/Preferences
General understanding of solid-state forms, screening, and instrumentation used in characterizing physical properties of pharmaceutical solids. Experience in developing the relationship of these properties to product quality, performance attributes, and process development.
Experience in technical considerations for equipment design and integration, process monitoring, integration of process analytical technology (PAT) systems, and scientific approaches on control strategies. Involvement with modeling and simulation tools, data analytics and predictive analytics.
Experience in design, development, control, and optimization of drug product manufacturing unit operations, especially knowledge in continuous manufacturing within the pharmaceutical industry.
Experience supervising or guiding the work of other scientists.
Basic understanding of regulatory/GMP aspects pertaining to development and clinical testing of drug products.
Additional Information
Possible exposure to chemicals, allergens, and loud noises.
Travel: 0 to 10%
Position Local: Onsite Monday through Friday, Indianapolis, IN; Lilly Technology Center-North (LTC-N)
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 $126,000 - $184,800. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day 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). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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Apply drug delivery fundamentals towards designing and optimizing phase appropriate drug products and processes from pre-FHD through commercialization for synthetic molecules.
Predict and assess the in vivo performance of drug molecules and formulations in preclinical species and humans using molecular properties and preclinical data. Leverage modeling to guide the development of preclinical and clinical formulations to enable the delivery of a broad range of synthetic molecules.
Refine clinical drug product prototypes, identify and mitigate technical risks to enable commercial products.
Collaborate and communicate project specific challenges and opportunities with key partners to plan and manage short/long term development activities aligned with the global CMC strategy.
Engage and influence internal and external scientific communities. Develop collaborations to solve technical challenges, identify and implement novel drug delivery and manufacturing technologies, influence clinical study design to benefit our patients.
Author and review high quality technical reports, peer reviewed publications, and regulatory documentation to support new technologies and/or regulatory submissions.
Basic Requirements
Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Material Science, or other related fields.
M.S. with 6+ years of demonstrated equivalent experience in a related field of expertise.
B.S. with 10+ years of demonstrated equivalent experience in a related field of expertise.
Additional Skills/Preferences
General understanding of solid-state forms, screening, and instrumentation used in characterizing physical properties of pharmaceutical solids. Experience in developing the relationship of these properties to product quality, performance attributes, and process development.
Experience in technical considerations for equipment design and integration, process monitoring, integration of process analytical technology (PAT) systems, and scientific approaches on control strategies. Involvement with modeling and simulation tools, data analytics and predictive analytics.
Experience in design, development, control, and optimization of drug product manufacturing unit operations, especially knowledge in continuous manufacturing within the pharmaceutical industry.
Experience supervising or guiding the work of other scientists.
Basic understanding of regulatory/GMP aspects pertaining to development and clinical testing of drug products.
Additional Information
Possible exposure to chemicals, allergens, and loud noises.
Travel: 0 to 10%
Position Local: Onsite Monday through Friday, Indianapolis, IN; Lilly Technology Center-North (LTC-N)
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 $126,000 - $184,800. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day 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). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#J-18808-Ljbffr