Principal/Senior Scientist, Process Development
The Role
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
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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
- 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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Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Research, Analyst, and Information Technology -
Industries
Internet Publishing
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