Principal/Senior Scientist, Process Development - ExThera Medical

The Role

We are seeking a highly motivated and experienced Scientist to join our team. The Principle Scientist will play a key role in the design, optimization, and scale-up of chemical processes for the manufacturing of our innovative blood filtration devices

A Few Key Responsibilities

• Provide strategic leadership and direction to the Manufacturing team focused on CMC activities, including process development, manufacturing, and regulatory compliance for Class Ill Medical Device/Biotech.
• Lead and mentor a team of scientists and engineers to drive innovative approaches for the synthesis, scale-up, and manufacturing of ExThera products.
• Collaborate with cross-functional teams including analytical /organic chemistry, formulation,
• to ensure seamless integration of CMC activities into product development programs.
• Oversee the design and execution of methods and process validations to optimize process efficiency and ensure product quality and consistency.
• Manage technology transfer activities between R&D and manufacturing sites, ensuring successful implementation of processes at commercial scale.
• Develop and maintain strong relationships with external partners including contract manufacturing organizations (CMOs}
• Stay current with industry trends, regulatory requirements, and guidelines related to CMC for biotech/pharmaceutical/medical device products and implement best practices to ensure compliance.
• Drive continuous improvement initiatives within the Manufacturing organization to enhance efficiency, productivity, and quality of CMC processes.
• Provide technical leadership and support for troubleshooting manufacturing issues and implementing corrective actions as needed.
• Generate and maintain comprehensive documentation including batch records, technical reports, and regulatory submissions.

• PhD in Organic Chemistry or related field with a minimum of 8 years of industry experience in pharmaceutical/biotech/class Ill medical device environment with a focus on CMC. Required.
• Demonstrated expertise in organic chemistry, process development, and manufacturing scale-up is a must.
• Strong knowledge of regulatory requirements and guidelines (e.g., FDA, ICH} related to CMC for pharmaceutical/biotech/class Ill medical device products.
• Excellent communication, presentation, and interpersonal skills with the ability to effectively collaborate with internal and external stakeholders.
• Strategic mindset with the ability to develop and execute innovative solutions to complex technical challenges.
• Detail-oriented with a commitment to maintaining high-quality documentation and regulatory compliance.

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