Associate II, Analytical Development

JOB SUMMARY

The Analytical Development associate will primarily be responsible for supporting analytical methodology evaluations and implementation (qualification) for use in routine QC testing. This highly motivated member of the Quality Unit will support the organization through the execution of activities such as CFU (potency testing), Microscopic characterization, and molecular method platform evaluations to support the assay transfer process to the QC lab for release testing. This AD team member will be responsible for initiating and assisting in qualification studies and technical writing activities while adhering to cGMP and GDP practices. 

ESSENTIAL JOB FUNCTIONS

• Actively participates in fostering a positive, collaborative work culture   
• Authoring and revision of standard operating procedures, test methods, protocols, and reports  
• Participate in execution of method qualifications, technical transfers, release testing, and method validations  
• Testing of material utilizing methods such as CFU, TCC, VCC, % Viability, growth kinetics, qPCR, Karl Fischer, bacterial enumeration, and bioburden  
• Data analysis and review  
• Perform equipment calibrations 
• Execute method and equipment troubleshooting and optimization, as needed.  
• Maintain documentation in accordance with GDP.  
• Other duties as assigned.

• B.S. degree in science or a life science-related field of study  
• 2-4 years of experience in Quality Control in GMP environment, preferably with experience in a microbiology laboratory  
• Proficiency in cell culture of microbiological organisms, operation of microscopes, and equipment calibrations (e.g. pH meters and balances)  
• Strong technical laboratory skills (e.g. pipetting, weighing, and measuring pH)  
• Experience with writing standard operating procedures and qualification protocols and reports  
• Familiarity with FDA, ICH, and EU Regulations and Guidelines 
• Involvement in continuous improvement initiatives and laboratory investigations  
• Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) experience desirable  
• Proficiency in Microsoft Office suite applications 
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Desirable Experience/Skills/Education