Scientist I, Quality Control

WuXi Biologics; Cranbury Township (NJ); On-site; USD 60,000 - 96,000; Full time

Job summary

WuXi Biologics is seeking a self-motivated Scientist l to join our Quality Control team in Cranbury Township, New Jersey. The role requires expertise in assay qualification, validation, and sample testing within a GMP environment for diverse biological modalities such as vaccines and antibodies.

The successful candidate will collaborate closely with internal teams to ensure project timelines are met while demonstrating strong analytical skills and effective communication.

Qualifications

• 4+ years of quality control experience with a Bachelor's, or 2+ years with a Master's.
• Hands-on experience with qPCR-based, ELISA-based, and cell-based assays.
• Strong data analysis and organizational skills.

Responsibilities

• Conduct assay transfer, qualification, validation, and routine testing.
• Generate, analyze, and document data in compliance with GMP.
• Collaborate with cross-functional teams for project delivery.

Skills

qPCR-based assay

ELISA-based assay

Cell-based assay

Data analysis

Communication skills

Education

Bachelor’s degree in Analytical Chemistry, Biochemistry, or related field

Master’s degree in Analytical Chemistry, Biochemistry, or related field

Tools

LIMS

Job description

Job Title

Scientist l, Quality Control (BIT Group)

Work Location

Cranbury NJ

Job Summary

We are seeking a self‑motivated professional to fill the role of Scientist l in our QC department at the New Jersey site. The successful candidate will provide assay qualification, validation, routine sample testing under GMP environment for iCMC and standalone projects for a wide variety of biological modalities, including but not limited to vaccine, ADC, RNA, and antibodies. The position involves close collaboration with internal teams and clients to ensure timely project deliveries.

Job Responsibilities

• Conduct assay transfer, qualification, validation, and routine testing for ELISA‑based assays, PCR‑based assays, and cell‑based assays.
• Generate, analyze, and document data with accuracy and compliance to GMP, GDP, and ALCOA+ standards.
• Perform second scientist review on worksheets and electronic data.
• Draft and review analytical method procedures, SOPs, protocols, and reports.
• Perform reagent qualification and cell banking activities.
• Participate in investigation of OOS, deviations, and atypical results; support root cause analysis and CAPA activities.
• Support method lifecycle activities, including transfer, qualification, validation, and maintenance.
• Collaborate with cross‑functional teams including Analytical Sciences, Manufacturing, and Quality Assurance to ensure timely project delivery.
• Utilize laboratory systems (e.g., LIMS and electronic systems) for data documentation and tracking.
• Support internal audits, client audits, and regulatory inspections as required.
• Support daily lab operation activities, including but not limited to lab equipment cleaning and maintenance.
• May be required to work on weekends or during off hours.

Job Qualifications

• Bachelor’s degree in Analytical Chemistry, Biochemistry, or related field with a minimum of 4 years of industry quality control experience.
• Or a Master’s degree in Analytical Chemistry, Biochemistry, or related field with a minimum of 2 years of industry quality control experience.
• Hands‑on experience with qPCR‑based, ELISA‑based assay is required.
• Hands‑on experience with cell‑based assay is required.
• Strong data analysis, organizational, and documentation skills.
• Strong communication and presentation skills.
• A minimum of two years of hands‑on experience in qPCR‑based, and ELISA‑based assay.
• A minimum of one year of hands‑on experience in cell‑based assay.
• Knowledge of PCR‑based, ELISA‑based assay principles.
• Knowledge of mammalian cell culture and cell‑based assay.
• Understanding of antibody and protein structural characteristics.
• Knowledge of large molecule drug development and life cycle management is preferred.
• Ability to adapt to fast‑paced working environment.
• Ability to adapt to frequent shift in responsibilities.
• Good communication and ability to work in a team‑oriented environment.
• Able to be organized and maintain a positive attitude in high‑stress working environment.

The anticipated pay range for this position is $60,000 - $96,000.

Job description does not intend to list all the duties and responsibilities assigned to this position. Employees holding this position would be required to perform other job‑related duties/responsibilities based on their expertise and company business needs.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.