Associate Director of Process Development & Manufacturing for Oligo-linker

Associate Director of Process Development & Manufacturing for Oligo-linker

About the Company: A leading player in the pharmaceutical industry, known for its innovative approaches and dedication to advancing health solutions.

About the Role: We are looking for a talented Associate Director to lead our AOC Process Development and Manufacturing team, focusing on Oligo-linker. This senior leadership role will oversee all stages of oligonucleotide process development and manufacturing, from initial development through Phase 3 and commercial scale-up.

The successful candidate will:

• Oversee technical aspects of oligonucleotide CMO process development.
• Provide expert guidance and ensure the execution of late-stage manufacturing strategies.
• Author and review regulatory filings, ensuring compliance with cGMP, FDA, and EMA standards.
• Lead technology transfer activities and manage a dedicated team to support our expanding pipeline.

Qualifications:

• Minimum of a Bachelor's degree in a relevant field; Master's or PhD preferred.
• At least 8 years of experience in the pharmaceutical industry, specifically in large-scale oligonucleotide synthesis and purification.
• Proven track record in process development, manufacturing, and technology transfer.
• Experience with IND and BLA filings is advantageous.

Skills:

Strong communication and interpersonal abilities are essential to thrive in our fast-paced environment. We seek a leader who can effectively identify and mitigate risks while fostering collaboration within our team and with external partners.

Travel Requirement: Less than 10%

Functions: Product Management, Medical Care/Hospital Administration, Information Technology