QC Scientist (I, II, III, IV)

Responsibilities:

• Perform all work in a safe and compliant manner in accordance with EHS best practices and cGMP guidelines.
• Work with management and vendors to acquire, install, and qualify new equipment.
• Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.
• Develop and execute analytical methods for small molecules, proteins, and antibody drug conjugates.
• Analysis of raw materials, in-process samples, finished products and stability samples by various analytical instruments and document the results under GMP settings.
• Prepare standard operating procedures (SOPs), analytical test methods, protocols, reports, etc. as needed.
• Conduct OOS, risk assessment, and root cause investigations and/or assist management with these investigations.
• Write deviations, change controls, and CAPAs, and/or assist management with these documents.
• Document work in laboratory notebooks and logbooks according to organizational GDP policies.
• Write, review, and execute of analytical protocols & reports for method transfers, qualification, and validations in GMP setting.
• Manage work outsourced to third-party analytical and metrology service providers.
• Perform detailed peer review of analytical data to ensure accuracy.
• Train and oversee junior scientists.

Skills

• Strong background in analytical sciences.
• Ability to work independently and in a team setting.
• Hands-on experience with various analytical techniques, including LC, LC-MS, spectroscopy, electrophoresis, KF, endotoxin, ELISA, etc.

Education and Experience

• Scientist I – BS with 0 years of relevant experience in GMP/CRO setting, MS or higher degree with at least 1 year of relevant experience in GMP/CRO setting, or equivalent combination of work experience, education, and training
• Scientist II – BS with at least 2 years of relevant experience in GMP/CRO setting, MS or higher degree with at least 0 years of relevant experience, or equivalent combination of work experience, education, and training
• Scientist III -BS with at least 3 years of relevant experience in GMP/CRO setting, MS or higher degree with at least 2 years of relevant experience, or equivalent combination of work experience, education, and training
• Scientist IV- BS with at least 4 years of relevant experience, MS or higher degree with at least 3 years of relevant experience, or equivalent combination of work experience, education, and training

Physical Demands

• Typically requires standing and walking for entire shift.
• Occasionally requires lifting of up to 20 pounds.
• Frequently requires the use of a step stool.
• Requires manual dexterity and visual abilities

Working Conditions

• Laboratory and office environment

Certificates & Licenses Required

• N/A