Remote CMC Director, Gene Editing Manufacturing

Confidential; United States; On-site; USD 179,088 - 199,752; Full time

Job summary

A biotechnology company is looking for a Director-level CMC Consultant focused on gene editing to lead manufacturing activities. This fully remote position requires extensive experience and expertise in gene therapy. The ideal candidate will manage relationships with CMOs and CROs, oversee the design and optimization of manufacturing processes, and have a strong background in regulatory submissions. A Master's or PhD is required along with at least 10 years in the industry.

Qualifications

• Minimum of 10 years of experience in biotechnology or pharmaceutical industry with a focus on CMC.
• Expertise in LNP, mRNA, AAV, and gRNA technologies.
• Strong background in manufacturing and regulatory requirements for gene editing.

Responsibilities

• Lead manufacturing activities and oversee vendor selection.
• Collaborate with partners on scalable manufacturing processes.
• Create budgets and timelines for CMC activities.

Skills

Leadership in manufacturing

Expertise in gene therapy product development

Budget management

Regulatory submission experience

Education

Master’s or PhD in Molecular Biology, Biochemistry, Biotechnology or related field

Job description

A biotechnology company is looking for a Director-level CMC Consultant focused on gene editing to lead manufacturing activities. This fully remote position requires extensive experience and expertise in gene therapy. The ideal candidate will manage relationships with CMOs and CROs, oversee the design and optimization of manufacturing processes, and have a strong background in regulatory submissions. A Master's or PhD is required along with at least 10 years in the industry.