Senior Scientist - Residual Assays, Analytical Research and Development

Job Description

Position Description:

Senior Scientist - Residual Assays, Analytical R&D

We invite individuals who possess a deep passion for promoting lifesaving and life-enhancing products to join our dynamic team. Our team is highly dedicated and committed to offering exceptional scientific oversight, driving the success of our Company's extensive range of products from candidate selection to market authorization.

At our company, we proudly continue to build upon a legacy of groundbreaking innovation while steadfastly upholding the highest standards of ethics and integrity. With a diverse workforce representing a multitude of languages and cultures, we stand unified in our collective mission to deliver revolutionary medicines and products with integrity and transparency. 

We are actively seeking an enthusiastic individual to join our Rahway, NJ team as a Senior Scientist (R3) in Biologics Analytical Research & Development (AR&D) GMP Operations. 

In this role, the selected candidate will be responsible for residual DNA and residual ELISA methods (e.g. HCP and ProA) including method optimization, phase-appropriate validation, early and late-stage transfers, analytical life cycle management, and release and stability testing. The successful candidate must be able to work in a fast-paced, multidisciplinary environment and will play a pivotal role supporting Biologics to advance commercialization efforts.   

The incumbent will collaborate closely with various stakeholders, including Analytical Development, Large Molecule Assay Validation, Quality Assurance, Technical Operations, and CMC Regulatory Affairs, to address technical challenges, provide scientifically sound guidance at each stage of development, and effectively manage deliverables to progress the pipeline. 

Responsibilities 

• Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP) using both traditional and advanced analytical tools. 

• ​Validate and implement analytical methods to support release and stability testing of clinical materials. 

• Act as subject matter expert (SME) across various franchises and analytical platforms. 

• Support biologics registrations, product launches, and troubleshooting activities. 

• Develop and manage project timelines and deliverables. 

• Support compliance audits, inspection activities, and investigation/CAPAs. 

• Author and review technical documentation including regulatory submissions. 

• Advance strategic initiatives across matrixed teams.  

• Additional responsibilities as assigned to support the evolving needs of the department.  

Position Qualifications:

Education Minimum Requirement:

• Ph.D. in biology, biochemistry or related field or

• M.S. with a minimum of 3 years of relevant experience or

• B.S. with a minimum of 7 years of relevant experience.    

Required Experience and Skills:

• Deep technical expertise with qPCR and ELISA. 

• Strong …