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Empirico · 1 day ago

Senior Scientist - CMC

Madison, WI

Full-time

Onsite

Mid, Senior Level

$110K/yr - $160K/yr

3+ years exp

Empirico is a clinical-stage biotechnology company that combines unmatched expertise in human genetics-driven target discovery with world-class capabilities in siRNA medicines. They are seeking a chemist to support the synthesis, purification, and characterization of oligonucleotides and their conjugates, with a focus on developing scalable processes for technology transfer to CDMOs.

BiotechnologyLife ScienceMedical

No H1B

Responsibilities

You will be responsible for supporting the synthesis, purification, and characterization of oligonucleotides and their conjugates, and optimizing methodologies to support the development of siRNA medicines

Perform solid-phase synthesis, purification, and characterization of oligonucleotides

Develop and optimize scalable upstream (synthesis) and downstream (purification, formulation) manufacturing processes

Support process development activities to enable successful technology transfer to CDMOs

Analyze, interpret, and clearly communicate synthetic and analytical data

Present findings to senior staff and cross-functional teams

Troubleshoot and refine synthesis and purification protocols

Manage multiple projects simultaneously in a fast paced environment

Support GLP related activities and IND-enabling process development efforts

Qualification

Solid-phase oligonucleotide synthesisAnalytical instrumentation NMRAnalytical instrumentation LC-MSAnalytical instrumentation RP-HPLCProcess developmentCGMP environment experienceTechnology transfer to CDMOsMethod development RPIP-HPLCMethod development AEX-HPLCGLP studies supportLyophilization experienceAseptic fill/finish operationsTangential flow filtration (TFF)

Required

This position requires a BS in Chemistry with at least 12 years of relevant industry experience, or an MS in Organic Chemistry, Biochemistry, or Chemical Engineering with at least 7 years of relevant experience, or a PhD with at least 3 years of relevant experience

Minimum 1 year of experience working in a cGMP environment with demonstrated understanding of cGMP principles

Hands-on proficiency with analytical instrumentation such as NMR, LC-MS, and RP-HPLC

Demonstrated ability in analytical and purification method development using RPIP-HPLC, AEX-HPLC, UV, MALDI, and HRMS

Background in process development and technology transfer to CDMOs, including development of scalable purification and formulation methodologies

Working knowledge of tangential flow filtration (TFF) method development

Experience supporting GLP studies and familiarity with regulatory expectations for IND-enabling work

Experience with lyophilization and aseptic fill/finish operations

Applicants must have authorization to work in the U.S

Preferred

Industry experience in solid-phase oligonucleotide synthesis is preferred, as well as familiarity with both upstream and downstream oligonucleotide manufacturing processes