MSAT Director

MSAT Director - Permanent - Texas, US

Are you ready to lead cutting-edge MSAT and assist in accelerate breakthroughs in biotech?

Proclinical is seeking a Director of MSAT to join a dynamic team and play a pivotal part in advancing and optimizing biotechnology processes.

Primary Responsibilities:

This position will be required to ensure the safe and efficient production of transformative medicines. This position involves collaboration across teams, process development, and technical leadership to support the manufacturing of innovative gene therapy products.

Skills & Requirements:

• Bachelor's degree in Biotechnology, Biochemistry, Biology, or a related field.
• Strong knowledge of cGMP regulations and experience in regulated environments (e.g., FDA, EMA).
• Proficiency in statistical data analysis software (e.g., JMP, Minitab) and process modeling tools.
• Demonstrated ability to track and measure performance against defined metrics.
• Self-motivated with a strong sense of urgency and the ability to lead and inspire teams.
• Passion for innovation and delivering transformative treatments for patients and families.
• Experience working in cleanroom environments and familiarity with safety protocols for hazardous materials.

The MSAT Director's responsibilities will be:

• Collaborate with cross-functional teams to support process transfers, scale-up, improvements, and troubleshooting activities.
• Design and execute experiments to evaluate and optimize manufacturing processes.
• Develop strategies for process characterization and validation as programs approach commercialization.
• Analyze data to drive process improvements and ensure product consistency and quality.
• Author, review, and revise technical documents, including protocols, reports, and SOPs.
• Provide technical expertise to resolve deviations, investigations, and out-of-specification (OOS) events.
• Support technology transfers by participating in risk assessments and ensuring regulatory compliance.
• Assist in the qualification and validation of new equipment and processes.
• Stay updated on industry trends and suggest innovative solutions to enhance processes.

If you are having difficulty in applying or if you have any questions, please contact Ed Little at e.little@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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