Associate Dir​/Director of External Manufacturing, Houston, TX Houston, TX​/Field Based

Associate Dir/Director of External Manufacturing, Houston, TX

Houston, TX / Field Based

At Genetix Biotherapeutics, every role has meaning, every team member is respected, and every day is a chance to make a difference. We pursue curative gene therapies to give patients and their families more days. We are doers, thinkers, and collaborators who embrace and live by our values: innovation rooted in team diversity, cooperation, and integration of multiple viewpoints. We approach every challenge with radical care.

This role is based in Houston, TX.

The Associate Director/Director, External Drug Product Manufacturing oversees relationships with the Contract Development and Manufacturing Organization (CDMO) to ensure reliable, compliant, and cost-effective production of commercial products. This role is local to the manufacturing site, serving as 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.

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

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 a 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

Base Salary Range: $183,000 - $231,000

Eligible for an annual bonus and long‑term incentive. Base salary may be adjusted based on experience, skills, education, market, and other factors. Benefits include comprehensive health, life and disability insurance; employer‑matched 401(k) plan; lifestyle spending account; flexible time‑off and paid holidays; tuition reimbursement; loan repayment assistance; paid parental leave; generous commuter subsidy; and more.

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, sexual orientation, national origin, genetics, disability, age, veteran status or any other legally protected characteristic.