QC Bioassay Scientist (I/II)

Job Details: Job Location: Headquarters- New Jersey - PRINCETON, NJ, Position Type: Full Time, Education Level: 4 Year Degree, Salary Range: $70000.00 - $100000.00Salary/year, Travel Percentage: None, Job Shift: Day, Job Category: Science, The primary role of the QC Bioassay Scientist is to provide analytical support for GMP manufacturing, process development, and stability studies. The QC Bioassay scientist will develop, qualify, and execute immunoassays, cell-based potency assays, and other 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 Bioassay Scientist supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.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.•    Manage samples and associated documentation for duration of sample lifecycle, both physically and electronically•    Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.•    Develop and execute ELISA, cell-based, other types of immunoassays, and plate based analytical methods for small molecules, proteins, and antibody drug conjugates with minimal supervision.•    Support lab management by tracking and replenishing critical reagents and consumable inventory. •    Conduct analytical testing of raw materials, in-process, finished, and stability samples in a GMP-compliant laboratory, with a primary but not limited focus on bioassays.•    Prepare standard operating procedures (SOPs), analytical test methods, protocols, reports, etc. as needed.•    Ensure test methods development and execution activities are conducted in accordance with applicable regulatory requirements, internal policies, scientific standards, and project timelines•    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 if needed.•    Perform detailed peer review of analytical data to ensure accuracy.•    Perform other tasks and assignments as needed and specified by management. Qualifications: Required Sills and Knowledge:•    Strong background in analytical sciences.•    Hands-on experience with various analytical techniques, including ELISA, PCR, SPR, BLI, flow cytometry, microscopy, Western blot, cell culture, 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 Requirement•    BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline.•    0 - 5 years of experience in a GMP manufacturing or CRO setting.Physical Demand•    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 Condidtion: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.