Piper Companies

This person will be joining a growing CMC team to lead the management of analytical development, quality control & validation activities.. This is a fully remote position that can sit anywhere in the US.. Support and author drug substance content for CMC Regulatory for US and Rest of World dossiers.. 10+ years of small molecule pharmaceutical manufacturing/process chemistry experience. Keywords: Chemistry, Chemical Engineering, small molecule, pharmaceutical manufacturing, process chemistry, late stage, process development, GMP, quality, Director, AD, Assistant Director, quality, regulatory, genetic diseases, QC, pharma, CDMO, Contract Development Manufacturing Organization, CMC, drug substance

associate director

Piper Companies is currently seeking a Senior Process Chemist for a company that finds, develops, and delivers breakthrough medicines for genetic diseases & disorders. This person will be joining a growing CMC team to lead the management of analytical development, quality control & validation activities. This is a fully remote position that can sit anywhere in the US. Responsibilities of the Senior Process Chemist (Associate Director): <ul><li> Manage contract development and manufacturing organizations to Process Chemistry activities for drug substance </li><li> Collaborate with the Analytical team within stability programs </li><li> Work cross functionally with Process Chemistry other CMC team members and communicate regularly </li><li> Support and author drug substance content for CMC Regulatory for US and Rest of World dossiers. </li><li> Utilize QC knowledge to support quality assurance audits. </li><li> Provide on-site technical support as needed for different manufacturing/scale-up/validation activities. Helping to troubleshoot any process issues with manufacturing/packaging. </li></ul> Qualifications of the Senior Process Chemist (Associate Director): <ul><li> 10+ years of small molecule pharmaceutical manufacturing/process chemistry experience </li><li> Degree (BS, MS, or Ph.D.) in Chemistry, Chemical Engineering or a related discipline </li><li> Late stage process development experience & working knowledge of GMP's, quality, & regulatory requirements </li><li> Ability to travel internationally up to 30% </li></ul> Compensation for the Senior Process Chemist (Associate Director): <ul><li>Salary Range: $190,000/year - $240,000/year base salary dependent on experience with bonus potential </li><li>Benefits: Comprehensive benefits package with competitive PTO</li></ul> Keywords: Chemistry, Chemical Engineering, small molecule, pharmaceutical manufacturing, process chemistry, late stage, process development, GMP, quality, Director, AD, Assistant Director, quality, regulatory, genetic diseases, QC, pharma, CDMO, Contract Development Manufacturing Organization, CMC, drug substance #LI-PB2 #LI-REMOTE #Pando

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