Responsibilities:
• Facility Management: Oversee the establishment and operation of a state-of-the-art GMP manufacturing suite designed for the production of stem cell-derived exosomes, incorporating a diverse array of processing technologies and capabilities initially tailored to wellness applications.
• Technical Expertise: Serve as a Subject Matter Expert on the operation of specialized equipment for exosome isolation, purification, and characterization, rapidly adopting new technologies and providing comprehensive guidance, training, and technical direction to the team.
• Experimentation: Design and conduct experiments to deepen process understanding and produce GMP-compliant batches of exosomes at multiple scales, ensuring consistency and quality for wellness applications.
• Systems Management: Accountable for developing, managing, and maintaining robust systems and procedures, including batch records, change controls, and SOPs, with a keen emphasis on operational efficiency and ongoing process enhancement in exosome manufacturing.
• Process Development Leadership: Lead process development initiatives to create scientifically grounded, well-characterized exosome products and manufacturing processes that are scalable, robust, and reproducible. Determine optimal parameters for prototype and final product manufacturing to guarantee consistent quality and efficacy for wellness applications.
• Technology Transfer: Implement a structured approach to Process Development and Technology Transfer to maintain consistency and uphold the highest quality standards in exosome manufacturing processes.
• Documentation: Prepare, review, and approve critical documentation, including protocols, reports, and regulatory submission sections, ensuring compliance with industry standards for wellness products.
• Compliance: Ensure full compliance with cGMP, safety, environmental regulations, and company policies, integrating these considerations into daily operations.
• Communication: Effectively communicate technical data and process insights to cross-functional teams and senior management, highlighting critical issues and proposing solutions as a recognized expert in exosome process development.
• Team Leadership: Lead, mentor, and develop junior team members in Manufacturing and Process Development, fostering a culture of excellence and continuous learning.
• Additional Duties: Undertake additional responsibilities as needed to support the team's objectives.

Basic Requirements:
• Education & Experience: Bachelor's Degree in bioengineering, biotechnology, or a related scientific discipline, with 5-10+ years of experience in the biopharmaceutical or biotechnology industry, preferably with a focus on exosome or nanoparticle manufacturing, including 2-3 years of team leadership.

Preferred Requirements:
• Technical Proficiency: Deep expertise in key processing techniques relevant to exosome manufacturing, including cell culture, exosome isolation and purification, aseptic processing, and formulation.
• Process Expertise: Proven track record in process development, scale-up, and technical transfer, specifically for exosome or similar nanoparticle-based products.
• Analytical Skills: Advanced skills in experimental design, data analysis, and interpretation, particularly for optimizing exosome yield, purity, and functionality.
• Problem-Solving: Strong technical problem-solving skills, leveraging the latest research and technologies in exosome science and manufacturing.
• Industry Knowledge: Comprehensive understanding of the product development lifecycle for wellness applications, with a focus on the critical role of process development in bringing exosome-based products to market.
• Leadership & Communication: Exceptional leadership abilities, with a collaborative approach, strong interpersonal skills, and outstanding communication capabilities, both verbal and written.
• Regulatory Expertise: In-depth knowledge of relevant regulatory guidelines (e.g., FDA, USP) for wellness products, with the ability to apply these standards appropriately throughout the development process.

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Manufacturing and Process Development Manager (Houston, TX)