Senior Director of Oligonucleotide Process Development and Manufacturing

Senior Director of Oligonucleotide Process Development and Manufacturing

About the Company

Join a top-tier pharmaceutical firm dedicated to innovation and excellence in the industry.

Industry

Pharmaceuticals

Type

Privately Held

About the Role

We are seeking an experienced Senior Director for Oligonucleotide Process Development and Manufacturing, with a primary focus on Oligo-linker technologies. In this critical senior leadership position, you will oversee all aspects of oligonucleotide process development and manufacturing from initial project phases through Phase 3 and into full commercial scale-up. The ideal candidate will bring expertise in oligonucleotide CMO process development while ensuring that late-stage manufacturing strategies are executed with precision and compliance.

Key responsibilities include :

• Providing expert technical guidance in oligonucleotide synthesis and purification.
• Maintaining a comprehensive understanding of cGMP, FDA, and EMA guidelines.
• Authoring and reviewing regulatory filings for IND and BLA submissions.
• Leading technology transfer activities and managing a dynamic team to support our advancing pipeline.
• Identifying and mitigating potential risks to ensure compliance with all regulations.
• Fostering collaborative relationships both internally and with external partners.

Qualifications :

If you are ready to take on a pivotal role in a dynamic company that values innovation and expertise, we encourage you to apply.

Travel Percent

Less than 10%

Functions