Senior QC Bioassay Scientist jobs in United States
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NJ Bio, Inc. · 8 hours ago

Senior QC Bioassay Scientist

NJ Bio, Inc. is a company focused on providing analytical support for GMP manufacturing and process development. The Senior QC Bioassay Scientist will develop, qualify, and execute various analytical test methods while managing a team of junior scientists and ensuring compliance with regulatory requirements.

BiopharmaBiotechnologyPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Manage and lead a group of junior scientists
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 ELISA, cell-based, other types of immunoassays, and plate based analytical methods for small molecules, proteins, and antibody drug conjugates
Support lab management by tracking and replenishing critical reagents and consumable inventory
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
Perform other tasks and assignments as needed and specified by management

Qualification

Analytical sciencesGMP experienceELISAAnalytical techniquesMicrosoft OfficeLeadershipPlanningOrganizationCommunication skillsProblem-solving skillsTeam collaboration

Required

Strong background in analytical sciences
Experience in leading people and projects
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 fulfill the business need
BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline
BS with at least 10 years of relevant experience, MS or higher degree with at least 5 years of relevant experience, or equivalent combination of work experience, education, and training
At least 5 years of experience in a GMP manufacturing or CRO setting
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

Company

NJ Bio, Inc.

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NJ Bio Inc. is a CRO that provides integrated chemistry and biology services to clients from the biotech and pharma sectors.

H1B Sponsorship

NJ Bio, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (9)
2023 (3)

Funding

Current Stage
Growth Stage
Total Funding
$15.62M
Key Investors
Cohance Lifesciences
2025-08-12Corporate Round· $10M
2024-12-06Acquired
2023-03-09Series Unknown· $5.62M

Leadership Team

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Naresh Jain
President and CEO
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Libu Mathew, CPA
Chief Financial Officer
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Company data provided by crunchbase