Quality Control Scientist ((I, II, III, IV, Senior)

Responsibilities:

The primary role of the QC Scientist is to provide analytical support for GMP manufacturing and process development. The QC scientist will develop, qualify, and execute analytical test methods for raw materials, highly potent APIs, antibody-drug conjugates (ADCs), and other pharmaceutical products in a GMP setting. The incumbent works cross-functionally with internal departments and external resources on QC related issues. The QC Scientist supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

• 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 in a GMP compliant lab.
• 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 analytical protocols & reports for method transfers, qualifications, 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.
• Perform other tasks and assignments as needed and specified by management.

Requirements:

Required Knowledge, Skills and Abilities:

• Strong background in analytical sciences.
• Hands-on experience with various analytical techniques, including LC, GC, LC-MS, spectroscopy, electrophoresis, KF, endotoxin, ELISA, etc.
• Proficiency with Microsoft Office
• Excellent verbal and written communication skills as well as interpersonal skills.
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil the business need.

Education and Experience Requirements:

• BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline.
• 0-10 years of experience in a GMP manufacturing or CRO setting.

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:

Office/ Laboratory position

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.