Manufacturing Scientist
1 month ago
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.
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