Senior Associate Scientist I, Quality Control

Job Title - Senior Assocaite Scientist, Quality Control (BIT Group)

Work Location - Cranbury NJ

Job Summary

We are seeking a self-motivated professional to fill the role our QC department at 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 collaborations 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 worksheet 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 (i.e. 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, lab 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 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 in PCR-based, ELISA-based assay principles.
• Knowledge in mammalian cell culture and cell-based assay.
• Understanding of antibody and protein structural characteristics
• Knowledge in large molecule drug development and life cycle management is preferred.
• Ability to adapt to fast-pace 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 keep positive attitude in high-stress working environment.

The anticipated pay range for this position is $60,000 - $96,0000

Job description does not intend to list all the duties and responsibilities assigned to this position. Employee 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