QC Scientist
Job Posting for QC Scientist at NJ Bio
QC Scientist
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.
Job 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 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.
Required Knowledge, Skills and Abilities
- Strong background in analytical sciences.
- Ability to work independently and in a team setting.
- Hands-on experience with various analytical techniques, including LC, GC, LC-MS, spectroscopy, electrophoresis, KF, endotoxin, ELISA, etc.
Education and Experience Requirements
- BS, MS degree in chemistry, biology, biochemistry, or related discipline.
- 0-4 years’ 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
- Laboratory and office environment
Certificates & Licenses Required
- N/A
Salary.com Estimation for QC Scientist in Princeton, NJ
$112,597 to $153,457
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Job openings at NJ Bio
NJ Bio
Princeton, NJ
Full Time
NJ Bio
Princeton, NJ
Full Time
NJ Bio
Princeton, NJ
Full Time
NJ Bio
Princeton, NJ
Full Time
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