Lilly
Scientific Lead Early Phase Oncology Pharmaceutics
Lilly, Boulder, Colorado, United States, 80301
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.
Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you can also count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Summary:
The Early Phase Oncology CMC Pharmaceutics team has an immediate opening for a Scientific Lead, Oncology Pharmaceutics candidate. The individual will be responsible for aspects of API physicochemical characterization as well as preclinical and clinical drug product formulations, including oversight and execution of laboratory development work and analytical testing.
More specifically the Pharmaceutics team is looking for an independent self-starter with a strong background in formulation laboratory techniques as well as designing dosage forms. This individual will be responsible for API characterization, formulation development, laboratory management, equipment management, preparation of technical reports and contributing to drug product sections of CMC regulatory submissions. Experience with the design, development, and manufacturing of liquid and enabled formulations for compounds with low solubility is also highly desired.
Responsibilities:
Work collaboratively with CMC colleagues (process chemistry and analytical chemistry) as well as discovery scientists (medicinal chemistry, DMPK, toxicology, and pharmacology) to develop and deliver appropriate formulations and drug products for preclinical and clinical development.
Design, plan and execute experiments related to physicochemical characterization and analysis of API, salts, cocrystals and polymorphs.
Design, develop and formulate suspensions, solutions, tablets, capsules, and spray dried dispersions for preclinical and clinical studies.
Manage and assist in development of appropriate analytical test methods and stability studies for drug product formulations.
Interface with contract research and manufacturing organizations to generate supporting data on API and formulations.
Maintain laboratory notebook, equipment and chemical inventory.
Provide written and verbal updates on assigned projects and activities as required.
Author and review technical documents and formulation development reports.
Basic Requirements:
Ph.D. or M.S. in pharmaceutics, chemistry, material science, chemical engineering, or related discipline with at least 6 years experience, or B.S. with 10+ years pharmaceutical industry experience.
Minimum of 3-5 years in a pharmaceutics and formulation development organization.
Additional Preferences:
Strong problem solving and excellent scientific knowledge in physicochemical analysis, material science, and formulation development.
A track record of successful development of oral solid dosage forms and enabled formulations (amorphous dispersions) is highly desired.
Experience with solubility determination, compatibility studies, formulation screening, dissolution, polymorph screening and physicochemical characterization of API as well as formulations.
Experience in instrumental techniques such as XRPD, DSC, TGA, DVS, HPLC and SEM.
Experience in formulation, process development and manufacturing of drug products including spray drying, blending, granulation, compression and coating.
Demonstrated ability to work well and collaborate with other accomplished professionals within and across functions/teams.
Ability to multi-task and shift priorities rapidly to meet tight deadlines.
Strong written and oral communication skills.
Detail oriented and well organized.
Enthusiastic, self-motivated, and keen to improve processes and overcome inefficiencies.
Additional Information:
Possible exposure to chemicals, allergens, and loud noises.
Occasional travel (0-10%) may be required.
Position Location: Boulder, CO.
Physical Demands/Travel:
The physical demands of this job are consistent with a lab environment.
Work Environment:
This position’s work environment is in a Laboratory.
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Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you can also count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Summary:
The Early Phase Oncology CMC Pharmaceutics team has an immediate opening for a Scientific Lead, Oncology Pharmaceutics candidate. The individual will be responsible for aspects of API physicochemical characterization as well as preclinical and clinical drug product formulations, including oversight and execution of laboratory development work and analytical testing.
More specifically the Pharmaceutics team is looking for an independent self-starter with a strong background in formulation laboratory techniques as well as designing dosage forms. This individual will be responsible for API characterization, formulation development, laboratory management, equipment management, preparation of technical reports and contributing to drug product sections of CMC regulatory submissions. Experience with the design, development, and manufacturing of liquid and enabled formulations for compounds with low solubility is also highly desired.
Responsibilities:
Work collaboratively with CMC colleagues (process chemistry and analytical chemistry) as well as discovery scientists (medicinal chemistry, DMPK, toxicology, and pharmacology) to develop and deliver appropriate formulations and drug products for preclinical and clinical development.
Design, plan and execute experiments related to physicochemical characterization and analysis of API, salts, cocrystals and polymorphs.
Design, develop and formulate suspensions, solutions, tablets, capsules, and spray dried dispersions for preclinical and clinical studies.
Manage and assist in development of appropriate analytical test methods and stability studies for drug product formulations.
Interface with contract research and manufacturing organizations to generate supporting data on API and formulations.
Maintain laboratory notebook, equipment and chemical inventory.
Provide written and verbal updates on assigned projects and activities as required.
Author and review technical documents and formulation development reports.
Basic Requirements:
Ph.D. or M.S. in pharmaceutics, chemistry, material science, chemical engineering, or related discipline with at least 6 years experience, or B.S. with 10+ years pharmaceutical industry experience.
Minimum of 3-5 years in a pharmaceutics and formulation development organization.
Additional Preferences:
Strong problem solving and excellent scientific knowledge in physicochemical analysis, material science, and formulation development.
A track record of successful development of oral solid dosage forms and enabled formulations (amorphous dispersions) is highly desired.
Experience with solubility determination, compatibility studies, formulation screening, dissolution, polymorph screening and physicochemical characterization of API as well as formulations.
Experience in instrumental techniques such as XRPD, DSC, TGA, DVS, HPLC and SEM.
Experience in formulation, process development and manufacturing of drug products including spray drying, blending, granulation, compression and coating.
Demonstrated ability to work well and collaborate with other accomplished professionals within and across functions/teams.
Ability to multi-task and shift priorities rapidly to meet tight deadlines.
Strong written and oral communication skills.
Detail oriented and well organized.
Enthusiastic, self-motivated, and keen to improve processes and overcome inefficiencies.
Additional Information:
Possible exposure to chemicals, allergens, and loud noises.
Occasional travel (0-10%) may be required.
Position Location: Boulder, CO.
Physical Demands/Travel:
The physical demands of this job are consistent with a lab environment.
Work Environment:
This position’s work environment is in a Laboratory.
#J-18808-Ljbffr