Senior Scientist, QC

JOB SUMMARY

The Senior Scientist will primarily be responsible for developing and leading late phase and commercial quality control activities. This highly motivated member of the Quality Unit will support the organization through the execution of activities such as raw material testing, release testing, stability testing, and environmental monitoring. This Quality team member will be responsible for initiating and assisting in investigations and troubleshooting 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
• Leads execution of stability testing, method qualifications, technical transfers, release testing, and method validations
• Testing of material utilizing methods such as HPLC, Particle size, qPCR, Karl Fischer, SDS-PAGE, bacterial enumeration, bacterial endotoxin, and bioburden
• Data analysis and review
• Initiate and participate in laboratory investigations including deviations and out of specifications
• Perform equipment calibrations and analysis of cell viability
• Execute method and equipment troubleshooting and optimization, as needed
• Maintain documentation in accordance with GDP

• S. degree in science or a life science-related field of study with 10+ Years’ experience
• Experience with the following instrumentation: HPLC, Coulometric Titrators, isolators, Zetasizers, MS, PCR,
• 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
• 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

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bending, standing, walking, lifting, sitting, carrying, stooping, crouching, kneeling repetitive motions typing- filing - writing
• Ability to lift and carry 25 pounds
• Travel