Associate Director, Manufacturing Science and Technology

Scorpion Therapeutics; Madison (WI); Hybrid; USD 140,000 - 190,000; Full time

Job summary

Arrowhead Pharmaceuticals is seeking an Associate Director, MS&T to lead process transfer, scale-up, and validation for oligonucleotide manufacturing. The role involves overseeing multidisciplinary teams, driving GMP validation activities, and ensuring regulatory compliance in a fast-paced RNAi therapeutics environment.

The successful candidate will bring advanced degrees with extensive GMP drug development experience, strong analytical skills, and proven leadership in cross-functional programs.

Qualifications

• 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.

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.

Skills

Leadership

Project management

Cross-functional collaboration

Analytical methods (HPLC-MS)

Troubleshooting

Education

PhD in Organic Chemistry

MS in related field

BS with 12+ years GMP experience

Job description

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.