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Principal/Senior Scientist, Process Development
Location:
Martinez, CA
Description:
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. What You Bring 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. Relocation benefits are not offered for this role. The expected salary range for this position based on the primary location of Martinez, Ca is $140,295 and $189,856. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. Powered by JazzHR
Company:
Exthera Medical
Posted:
March 7 on The Resumator
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More About this Listing: Principal/Senior Scientist, Process Development
Principal/Senior Scientist, Process Development is a Science & Pharmaceutical Scientist Job at Exthera Medical located in Martinez CA. Find other listings like Principal/Senior Scientist, Process Development by searching Oodle for Science & Pharmaceutical Scientist Jobs.
Principal/Senior Scientist, Process Development is a Science & Pharmaceutical Scientist Job at Exthera Medical located in Martinez CA. Find other listings like Principal/Senior Scientist, Process Development by searching Oodle for Science & Pharmaceutical Scientist Jobs.