Confidential
Associate Director of Process Development & Manufacturing for Oligo-linker
Confidential, Charlotte, North Carolina, United States, 28245
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
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