Associate Director, Manufacturing Science and Technology

Role

Associate Director, MS&T leading process transfer, scale-up, and validation for oligonucleotide manufacturing at Arrowhead Pharmaceuticals, a leader in RNAi therapeutics.

Responsibilities

• oversee teams of scientists, engineers, and documentation specialists;
• manage GMP process validation and tech transfer activities;
• ensure compliance with FDA, EMA, ICH guidelines;
• lead troubleshooting, process optimization, and implementation of new technologies;
• provide mentorship and stakeholder updates.

Requirements

• PhD in Organic Chemistry or related field with 6+ years, MS with 10+ years, or BS with 12+ years in GMP drug development, scale-up, and manufacturing—preferably in oligonucleotides or related chemistries;
• strong understanding of analytical methods like HPLC-MS, UV, NMR;
• proven experience in process validation, GMP documentation, and technology transfer;
• demonstrated leadership, project management, and cross-functional collaboration skills.

HighValue

• GMP oligonucleotide manufacturing,
• process validation,
• technology transfer,
• regulated environments,
• cross-functional leadership,
• compliance with global regulatory standards.

Work Setup

not specified; likely in a hybrid or onsite facility in Wisconsin.