Associate Dir/Director of External Manufacturing, Allendale, NJ

About Genetix Biotherapeutics

At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

Location:

This role is based in Allendale, NJ

Position Summary:

The Associate Director/Director, External Drug Product Manufacturing will oversee relationships with the Contract Development and Manufacturing Organization (CDMO) to ensure reliable, compliant, and cost-effective production of commercial products. This role will be local to the manufacturing site to be the accountable, on-site presence for our manufacturing partner. The ideal candidate has extensive experience managing complex biologics or cell and gene therapy manufacturing processes, strong technical and operational expertise, and proven success building and leading high-performing external manufacturing partnerships.

RESPONSIBILITIES

External Manufacturing Oversight

• Lead cross-functional teams (QA, QC, Supply Chain, Regulatory, MS&T) to support successful technology transfer, scale-up, and production improvement initiatives
• Monitor manufacturing campaigns to ensure adherence to timelines, budgets, quality standards, and regulatory compliance
• Drive continuous improvement, operational excellence, and risk mitigation initiatives within the external manufacturing network
• Ensure CDMOs meet agreed-upon KPIs, quality expectations, timelines, and budget requirements

Technical & Operational Leadership

• Provide technical and operational direction for manufacturing activities as the first point of contact for any issues that arise during manufacturing campaigns
• Partner with Process Development and MSAT teams to support tech transfer, process characterization, and manufacturing readiness.
• Evaluate and resolve complex technical issues during clinical and commercial production campaigns.

Quality & Compliance

• Ensure external manufacturing operations comply with FDA and GMP requirements
• Support Quality and Regulatory functions during inspections, audits, and filing activities
• Support work in the quality system space including change control, CAPA, deviation management, and batch review

Strategic Planning & Vendor Management

• Develop long-term external manufacturing strategies aligned with and commercial forecasts.
• Support the negotiation of contracts, service agreements, and pricing in collaboration with Legal and Procurement teams
• Support JLT and JPT governance with as CDMO partners

QUALIFICATIONS

Education & Experience

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related field required; advanced degree (MS, PhD, MBA) preferred.
• 10+ years of experience in biopharmaceutical manufacturing, with at least 5 years in cell & gene therapy
• Proven track record managing CDMOs or external manufacturing partnerships.

Skills and Competencies

• Strong understanding of cell & gene therapy manufacturing processes
• Exceptional leadership, communication, and cross-functional collaboration skills
• Preferred experience in prior MS&T role
• Familiarity with tech transfer, process validation, and regulatory expectations for advanced therapies.

Key Attributes

• Strong leadership, communication, and cross-functional collaboration skills
• Ability to influence and lead complex vendor relationships
• Strategic thinker with strong project management and problem solving skills

Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.  All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.