Director of Manufacturing

Neurotech Usa Inc; Cumberland (RI); On-site; USD 175,000 - 200,000; Full time

Job summary

Ein innovatives biopharmazeutisches Unternehmen sucht einen Director of Manufacturing, um die Herstellungsoperationen für Zell- und Gentherapien zu leiten. Diese Schlüsselrolle umfasst die Entwicklung strategischer Pläne, die Sicherstellung der GMP-Compliance und die Förderung einer Kultur der kontinuierlichen Verbesserung. Mit über 20 Jahren Erfahrung in der Branche bietet das Unternehmen ein dynamisches Umfeld, in dem Sie Ihre Führungsqualitäten und technischen Fähigkeiten einsetzen können, um bedeutende Fortschritte in der Behandlung von retinalen Erkrankungen zu erzielen. Wenn Sie eine Leidenschaft für biopharmazeutische Innovationen haben und in einem schnelllebigen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Qualifications

• 7+ Jahre Erfahrung in der Zell- und Gentherapie-Herstellung und -Führung.
• Starker Hintergrund in einem cGMP-biopharmazeutischen Umfeld.

Responsibilities

• Entwicklung und Verbesserung der Herstellungsstrategie und -verfahren.
• Sicherstellung der fristgerechten Produktion von GMP-Material.

Skills

Qualitäts- und Compliance-Management

Technische Expertise in Zell- und Gentherapie

Aseptische Herstellungsoperationen

Projektmanagement

Kommunikationsfähigkeiten

Führungskompetenz

Education

Bachelor- oder Masterabschluss in einem verwandten Bereich

Job description

Join to apply for the Director of Manufacturing role at Neurotech Pharmaceuticals, Inc.

Neurotech Pharmaceuticals, Inc. provided pay range

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

Base pay range

$175,000.00/yr - $200,000.00/yr

Neurotech Pharmaceuticals is an innovative biopharmaceutical company located in Cumberland, RI and Needham, MA, within Greater Boston’s vast biotechnology landscape. Since our inception more than 20 years ago, we have been developing a proprietary drug delivery platform for treatment of a variety of retinal disorders. Our drug delivery platform - Encapsulated Cell Technology (ECT) platform is designed to deliver genetically modified therapeutics to slow the progression of chronic retinal diseases. Our most advanced program is delivering a neurotrophic factor to treat the orphan disease Macular Telangiectasia Type 2 (MacTel). For over two decades, we have pioneered the development of our proprietary Encapsulated Cell Therapy (ECT) platform, designed to address chronic retinal diseases. Our lead program focuses on Macular Telangiectasia Type 2 (MacTel), a rare retinal disorder, leveraging ECT's innovative approach to provide sustained, targeted treatment directly to the eye.

Job Responsibilities

1. Develop and improve manufacturing operations strategy and procedures in collaboration with all departments.
2. Ensure timely production of GMP material according to manufacturing timelines and demand plan.
3. Develop strategic plans for cell and gene therapy manufacturing, including resource allocation, budgeting, and performance metrics.
4. Establish cross-functional planning meetings and manage manufacturing schedules to ensure operational coordination.
5. Ensure adequate trained manpower resources and compliance with GMP regulations and SOPs.
6. Lead investigations related to manufacturing processes, including authoring deviations, nonconformances, CAPAs, and change controls.
7. Participate in strategies for Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA).
8. Manage process batch records and equipment processes to ensure GMP readiness and performance.

Qualifications

• Bachelor’s or Master’s degree in a related field.
• 7+ years of experience in cell and gene therapy manufacturing and leadership.

Knowledge, Skills & Abilities

• Strong quality and compliance background in a cGMP biopharmaceutical environment.
• Technical expertise in cell and genetic therapy manufacturing, especially allogeneic cell therapy.
• Experience with equipment and facility qualification and validation.
• Proficiency in aseptic manufacturing operations.
• Project management skills for complex projects.
• Excellent communication skills.
• Proven leadership with focus on team development and innovation.
• Ability to work calmly in a fast-paced environment and provide hands-on support as needed.