Associate Scientist, Purification Process Development
Pay: $43-$45.27 per hour
Duration: 12 months
Location: Oceanside, CA (Onsite 5 days)

Key Responsibilities: 

• Contribute to experimental design. Plan and execute assigned purification process development laboratory studies. Support process scaleup and implementation in internal and external GMP facilities. 
• Collect and analyze data from laboratory experiments in compliance with data integrity policy. Author experimental protocols and reports. 
• Support process transfer to internal and contract manufacturing facilities to produce GMP and non GMP drug substances on time and with high success rate.  
• Provide technical support for manufacturing atypical event investigations. 
• Ensure high-quality documentation in electronic laboratory notebooks, protocols and reports. 
• Mentor junior team members on purification process development strategies, experimental design and execution as well as process transfer. 
• Help to establish and maintain a state-of-the-art purification lab. 
• Execute purification platform development and new technology/innovation evaluation and implementation to enable pivotal clinical trials. 
• Participate in cross functional initiatives as needed. 
• Adhere to department budget and all training, compliance and safety requirements. 

 Qualifications/Skills/Experience: 

• M.S. with 2+ years or BS with 4+ years' experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering). 

Preferred Qualifications: 

• Hands-on laboratory operations experience with purification process operations including centrifugation, normal flow filtration, high throughput purification screening and development, chromatography operations, tangential flow filtration, and virus inactivation/removal is required. 
• Experience with AKTA chromatography systems and UNICORN software is preferred
• Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities.  
• Working knowledge of lab automation, data management, data science, knowledge management and data protection. 
• Demonstrated ability to collaborate and influence cross-functionally. 
• Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire). 
• Motivated self-starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation, and scientific writing skills.