Senior Research Associate / Assistant Director, ADQC
Scorpion Therapeutics, Carlsbad, New Mexico, us, 88221
Role Summary
Seeking an experienced analytical chemist to join our Analytical Development & Quality Control (ADQC) group at the Sr. Research Associate, Senior Scientist or Assistant Director level (depending on experience). The ideal candidate will be familiar with a broad range of analytical chemistry techniques, possess a strong work ethic and strong technical background, demonstrate excellent oral and written communication skills, and have experience working in a GMP environment. The successful candidate will be able to perform the following responsibilities with a high degree of independence and attention to detail. Responsibilities
Manage the analytical activities for oligonucleotide therapeutic development projects Coordinate and execute testing of drug substance intermediate, drug substance, and drug product samples for release and stability studies Manage outsourced analytical activities at external contract labs Conduct analytical investigations Develop and optimize analytical methods Develop drug substance specifications ensuring efficient integration across Chemistry, Manufacturing, and Controls (CMC) and other relevant disciplines such as Clinical and Toxicology Design and execute method validation and method transfer protocols Author scientific reports and portions of the CMC section of regulatory filings Present at internal and cross-functional scientific meetings Qualifications
BS or MS with at least 5 years (Sr. Research Associate) or 8 years (Assistant Director) of industry experience in Analytical Chemistry or related discipline Ph.D. with at least 2 years (Sr. Scientist) or 8 years (Assistant Director) of industry experience in Analytical Chemistry or a related discipline Skilled in operating LC-MS, HPLC, and GC for the analysis of drug substance and drug product samples Good understanding of the drug development process Practical knowledge of GMP requirements, with hands-on GMP experience preferred Good understanding of ICH and FDA method validation guidelines, including phase-appropriate strategies Ability to problem solve, manage priorities and maintain aggressive timelines for multiple projects Ability to work productively and independently within a team or matrix environment Excellent written and verbal communication skills
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Seeking an experienced analytical chemist to join our Analytical Development & Quality Control (ADQC) group at the Sr. Research Associate, Senior Scientist or Assistant Director level (depending on experience). The ideal candidate will be familiar with a broad range of analytical chemistry techniques, possess a strong work ethic and strong technical background, demonstrate excellent oral and written communication skills, and have experience working in a GMP environment. The successful candidate will be able to perform the following responsibilities with a high degree of independence and attention to detail. Responsibilities
Manage the analytical activities for oligonucleotide therapeutic development projects Coordinate and execute testing of drug substance intermediate, drug substance, and drug product samples for release and stability studies Manage outsourced analytical activities at external contract labs Conduct analytical investigations Develop and optimize analytical methods Develop drug substance specifications ensuring efficient integration across Chemistry, Manufacturing, and Controls (CMC) and other relevant disciplines such as Clinical and Toxicology Design and execute method validation and method transfer protocols Author scientific reports and portions of the CMC section of regulatory filings Present at internal and cross-functional scientific meetings Qualifications
BS or MS with at least 5 years (Sr. Research Associate) or 8 years (Assistant Director) of industry experience in Analytical Chemistry or related discipline Ph.D. with at least 2 years (Sr. Scientist) or 8 years (Assistant Director) of industry experience in Analytical Chemistry or a related discipline Skilled in operating LC-MS, HPLC, and GC for the analysis of drug substance and drug product samples Good understanding of the drug development process Practical knowledge of GMP requirements, with hands-on GMP experience preferred Good understanding of ICH and FDA method validation guidelines, including phase-appropriate strategies Ability to problem solve, manage priorities and maintain aggressive timelines for multiple projects Ability to work productively and independently within a team or matrix environment Excellent written and verbal communication skills
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