Associate Director of Process Development & Manufacturing for Oli...
Confidential - San Jose
Work at Confidential
Overview
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Overview
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