We are seeking a highly motivated and experienced Scientist to join our team. The Principal 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.
