Validation of Analytical Procedures Specialist

New England Biolabs, Inc. (NEB)
Job Location
Ipswich, MA
Job Description

The Quality Improvement (QI) group at New England Biolabs is inviting applicants for the position of Validation of Analytical Procedures Specialist. The ideal candidate will be responsible for developing, coordinating and maintaining the program to validate analytical procedures used to test and release enzymes, nucleic acids and other products manufactured by NEB. 

Primary Responsibilities: 
• Responsible for management of validation work-flow from planning and testing to implementation into production. 
• Write validation master plans. 
• Coordinate the validation of instruments used for analytical testing. 
• Write and revise Standard Test Methods (STMs) and train individuals to perform them. 
• Perform analytical testing. 
• Qualify reference materials. 
• Coordinate and document interdepartmental testing (Research, Product Development and Quality Control). 
• Troubleshoot and improve quality control assays. 
• Verification of compendial methods. 
• Transfer of Analytical Methods to cGMP manufacturing.

Qualifications and Experience: 
• Bachelor’s degree in biology, chemistry or related field; Masters preferred. 
• 5 years’ experience in validation project management and/or analytical procedure validation experience. 
• Thorough understanding of enzyme biochemistry and the kinetics of enzyme action. 
• Understanding of current Good Manufacturing Practices. 
• Experience with a wide range of lab instrumentation. 
• Familiarity with ICH Validation Guidelines. 
• Critical appreciation of experimental design. 
• Ability to multitask and adopt new projects as needed. 
• A high level of organizational ability. 
• Working knowledge of Statistical Analysis. 
• Strong interpersonal skills. 

New England Biolabs is an Equal Opportunity/ Affirmative Action Employer of Minorities, Females, Disabled and Protected Veterans 

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