Associate Downstream Process Development Scientist Jobs in Texas

Client is seeking a passionate and dedicated Manufacturing and Process Development Manager to be part of our dynamic team at the forefront of regenerative medicine. As a Manufacturing and Process Development Manager, you will oversee the GMP manufacturing facility and lead the Manufacturing and Process Development team, providing expert technical guidance for the development, scale-up, and transfer of stem cell-derived exosome manufacturing processes tailored for the wellness industry. The ideal candidate will excel in a collaborative, cross-functional team setting, driving key decisions to ensure the successful creation of innovative wellness products. You will work alongside leading experts in the field, contributing to groundbreaking research that can revolutionize the future of health and wellness. This is an exciting opportunity to be part of a visionary company dedicated to pushing the boundaries of science and improving lives on a global scale.
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.