Director

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

This range is provided by Confidential. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$130.00/hr - $145.00/hr

Job Title: CMC Consultant (Director Level) - Gene Editing

Location: 100% REMOTE

Client Overview

Client is an Oncology-focused biotherapeutics development company with a ground-breaking gene editing platform technology. Their proprietary in vivo gene editing platform has broad applicability for 30+ squamous cell carcinomas and enhances tumor cell stress response to all standard of care treatments.

The Work

They need a highly experienced CMC gene-editing professional to lead manufacturing activities. They have a clinical advisory board, are working with Precision for Medicine (CRO) for protocol development, and the Danahel group for CMC regulatory support.

They require this person to lead manufacturing activities, oversee vendor selection, oversee tech transfers (as needed), serve in an “Interim Head” capacity, and oversee design, development, and optimization of scalable manufacturing processes in collaboration with internal and external partners.

• Oversee the design, development, and optimization of scalable manufacturing processes, in collaboration with internal and external partners
• Manage relationships with contract manufacturing organizations (CMOs), contract research organizations (CROs), and other external partners
• Create budgets, timelines, and resource needs for all CMC activities
• Master’s or PhD in Molecular Biology, Biochemistry, Biotechnology, or a related field
• A minimum of 10 years of experience in the biotechnology or pharmaceutical industry, with a focus on CMC and gene therapy product development
• Expertise in LNP, mRNA, AAV, and gRNA technologies, and a deep understanding of the manufacturing and regulatory requirements for gene editing products
• Proven track record of successful regulatory submissions and approvals for genomic medicine INDs
• Must have experience licensing components for manufacturing
• Must have experience working through tariff and customs processes

Seniority level

• Director

Employment type

• Full-time

Job function

• Research and Manufacturing

Industries

• Pharmaceutical Manufacturing and Biotechnology Research