Scientist, Development & Quality

Gator Bio is a pioneering biotech company dedicated to transforming healthcare through innovative solutions. Located in Palo Alto, California, we develop and deliver cutting-edge bioanalytical tools that empower life science researchers across a wide range of fields. Our mission is to accelerate biological analysis, enabling groundbreaking discoveries in life sciences, drug discovery, and pharmaceutical development. 

We are seeking a highly motivated and talented Scientist to join our R&D team and play a pivotal role in the development and continuous improvement of our biosensor product. The successful candidate will be responsible for ensuring that our products consistently meet and exceed the highest quality standards, delivering exceptional value to our customers. 

Essential Duties and Responsibilities

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Investigate and Resolve Quality Issues 

• Conduct thorough root cause analyses of non-conforming reports (NCRs) and customer complaints to identify underlying issues and implement effective corrective actions. 
• Drive continuous improvement initiatives by proactively monitoring product quality performance to identify potential process deviations and implement solutions to enhance quality, efficiency, and cost-effectiveness. 
• Troubleshoot manufacturing technical challenges and provide technical support to resolve issues promptly.
• Develop and execute change control validation plans to ensure the integrity of our products and processes, adhering to Quality Management System (QMS) procedures. 




Technical Expertise and Documentation:

• Contribute to the development and maintenance of design history files to accurately document product development processes.
• Collaborate with manufacturing teams across multiple sites to facilitate smooth technology transfer and provide ongoing technical support for production processes. 




Leadership and Project Management 

• Demonstrate strong leadership skills in managing projects, overseeing team functions, and mentoring junior scientists.
• Effectively manage projects, including scheduling, budgeting, resource allocation, and tracking deliverables to ensure timely completion and achievement of team goals.

Qualifications

• Master's or Ph.D. degree in a relevant scientific field (e.g., Biochemistry, Bioengineering, Analytical Chemistry) with 3+ years of working experience.Hands-on experience in biochemistry, analytical or molecular biology laboratory is required. 
• Working knowledge of protein conjugation, optical system, biomaterial, solid phase chemistry, immunoassay (e.g., ELISA), antibody engineering, Surface Plasmon Resonance (SPR) or BioLayer Interferometry (BLI) is desirable. 
• Experience working in both R&D and manufacturing environments, including process optimization, troubleshooting, and quality control.
• Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
• Proven experience in bioanalytical product development and a strong understanding of Quality Management Systems (QMS).
• Proficiency in using QT-9 software is highly desired.
• Excellent problem-solving, analytical, and organizational skills.
• A passion for innovation and a commitment to delivering high-quality products.A positive and resilient attitude to thrive in a fast-paced and dynamic work environment. 

Position Requirements

• Ability to lift, push, pull, carry, and/or move 20 lbs. 
• This role will require long periods of standing and sitting. 
• The employee will be required to use hands for computer work and pipetting. 
• Required biosafety training upon hiring. 
• Must pass a health screening.