Job Title – Scientist I-Analytical Sciences
Work Location – Cranbury, NJ
Job Summary:
We are seeking a self-motivated professional to fill the role of Scientist I in our AS department at New Jersey site. The successful candidate will provide analytical support 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 development, transfer, optimization, assessment, and routine testing for ELISA-based assays, PCR-based assays, and cell-based assays.
- Design and execute experiments to develop, optimize, and troubleshoot analytical methods for biologics characterization.
- Generate, analyze, and document data with high scientific rigor, ensuring accuracy and compliance to quality standards.
- Interpret analytical data and provide scientific insights to support process development and product understanding.
- Lead iCMC and standalone analytical projects as Analytical Sciences Function Lead, including client communication, cross-team communication, analytical strategy development, method selection, and project execution.
- Coordinate analytical activities includingsample testing, protocol drafting, review, leading RS generation and qualification, stability program management.
- Collaborate with cross-fuctional teams (PD, MFG, QC, MSAT) to support project deliverables.
- Support lab operation including lab equipment maintenance, lab cleaning and organization, reagent preparation, and inventory management.
- Utilize electronic systems or analytical software tools for data documentation and analysis.
- Trained on GMP practices and support GMP activities on a need base.
- May be required to work on weekends or during off hours.
Qualifications:
- Bachelor’s degree in Analytical Chemistry, Biochemistry, or related field with a minimum of 4 years of industry analytical development or quality control experience.
- Or Master’s degree in Analytical Chemistry, Biochemistry, or related field with a minimum of 2 years of industry analytical development or quality control experience.
- Hands-on experience with qPCR-based, ELISA-based assay is required.
- Hands-on experience with cell-based assay is required.
- Knowledge on HPLC-based assays, CE-SDS, and iCIEF is preferred.
- Knowledge on drug life cycle management is prefered.
- 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
- 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.
Soft Skills - Behavioural Competencies
- 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 salary range for this position is $60,200-96,300
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