The Quality Control Lead Engineer is responsible for performing, analyzing and investigating quality control assays, including in-process, release and stability tests, developing and performing & analyzing environmental monitoring, identifying trends and leading assay development and validation tasks as directed by supervisor, providing qualification and validation support for manufacturing processes that are essential to the clinical production.  

Perform all GMP related activities strictly according to SOPs with accurate and complete documentation associated with the testing, in compliance with cGMP, principles of Data Integrity and good documentation practices. Leads self and others in investigations and process improvements including CAPAs and Change Controls.  Ensures compliance with all applicable Federal and State accrediting agency requirements in the testing of biopharmaceutical products manufactured in the current Good Manufacturing Practices (cGMP) facility.  Lead in identifying, adapting, optimizing and validating new analytical procedures for testing as necessary and is a subject matter expert (SME) multiple areas of QC operations.  Responsible for developing, reviewing and revising Standard Operating Procedures as necessary. Performs general laboratory activities as assigned by supervisor. Complete and maintain updated all training required to perform assigned tasks and develops and implements training programs.  Leads audits of processes and data and a point of contact for external audits

• A doctorate’s degree in a biomedical related field (biology, chemistry/biochemistry, laboratory medicine, etc.) with at least 3 years relevant experience within a laboratory environment OR a master’s degree in a biomedical related field plus a minimum of 4 years of relevant experience OR a bachelor’s degree in a biomedical related field and a minimum of 8 years relevant experience. 
• Experience within a complex research/laboratory environment and increasing responsibilities in a cGMP related development and/or manufacturing platform for clinical-grade products intended for human use is required.
• Must have strong experience in developing and executing SOPs and strong technical understanding and experience developing & validating assays in a cGMP environment. 
• Ability to analyze data and compose reports. 
• Ability to effectively communicate complex ideas to a variety of shareholders across functions through multiple forms of communications. 
• An understanding of the application of laws, regulations, and guidance documents related to FDA regulated biologics, pharmaceuticals, devices, etc, including those for Data Integrity. 
• Exceptional human relations and communication (written, verbal, and listening) skills. 
• Flexibility and capable of adapting to and facilitating change. 
• Must demonstrate capacity to comprehend complex protocols, programs, and situations. 
• Ability to exercise good judgment while working under deadlines is required.
• Must be flexible with work schedule as needed to meet internal and external customer needs.

Visa sponsorship is not available for this position.  This position is not eligible for F-1 OPT STEM extension.