We are seeking a talented and motivated Manufacturing Scientist/Engineer to join a Biotech company located in Redwood City. The ideal candidate will play a pivotal role in the development and optimization of manufacturing processes. This position offers an exciting opportunity to contribute to the advancement of cutting-edge treatments aimed at improving and enhancing patient health.
Key Responsibilities:
Develop and optimize manufacturing processes for biologic products, including but not limited to gene therapies, cell-based therapies, and biologics.
Design and execute experiments to characterize critical process parameters (CPPs) and optimize manufacturing processes to ensure product quality, yield, and scalability.
Collaborate cross-functionally with research and development, process development, quality assurance, and regulatory affairs teams to transfer processes from development to manufacturing scale.
Lead technology transfer activities to external manufacturing partners, ensuring seamless transfer of processes and providing technical support as needed.
Establish and maintain manufacturing documentation, including batch records, standard operating procedures (SOPs), and manufacturing instructions, in compliance with regulatory requirements.
Implement process improvements and drive continuous process optimization initiatives to enhance efficiency, productivity, and cost-effectiveness.
Perform risk assessments and troubleshoot manufacturing issues to identify root causes and implement corrective and preventive actions (CAPAs) to ensure uninterrupted supply of product.
Support manufacturing activities, including equipment qualification, validation, and maintenance, to ensure compliance with cGMP regulations and industry standards.
Participate in cross-functional teams to support regulatory filings, including IND submissions, BLA filings, and regulatory inspections.
Stay abreast of advancements in biotechnology, and manufacturing technologies to drive innovation and maintain a competitive edge in the market.
Qualifications:
Bachelor's or Master's degree in biological sciences, chemical engineering, bioengineering, or related field.
5+ years of experience in biopharmaceutical manufacturing, process development, or related field, preferably in biologics.
Hands-on experience with upstream and downstream bioprocessing techniques, including cell culture, purification, and aseptic processing.
Strong understanding of cGMP regulations, FDA guidelines, and industry best practices for biologics manufacturing.
Demonstrated ability to design and execute experiments, analyze data, and troubleshoot technical issues independently.
Excellent communication skills and ability to collaborate effectively with cross-functional teams in a fast-paced, dynamic environment.
Experience with technology transfer and external manufacturing is a plus.
Proficiency in statistical analysis software (e.g., JMP, Minitab) and process modeling tools is desirable.
Ability to adapt to changing priorities and handle multiple projects simultaneously while meeting deadlines.