Senior Scientist, Biologics Analytical Research & Development

Job Description

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 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 seeking an enthusiastic Senior Scientist (R3) to join our Rahway, NJ team in Biologics Analytical Research & Development (AR&D) GMP Operations in Rahway, NJ. The role supports cleaning validation by developing and validating analytical assays for manufacturing equipment (e.g., HPLC/UPLC, TOC, LC-MS, conductivity). Responsibilities include executing separation-based analytical methods (HPLC, UPLC, CE, iCIEF), optimizing methods, performing validation, managing transfers, handling life cycle management, and conducting release and stability testing. Candidates should excel in a fast-paced, multidisciplinary environment and contribute to advancing Biologics commercialization. 

The incumbent will work with stakeholders such as Technical Operations, Manufacturing, Analytical Development, Large Molecule Assay Validation, Quality Assurance, and CMC Regulatory Affairs to solve technical issues, offer scientific guidance throughout development, and manage deliverables to advance 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 execution of cleaning assays, and release and stability testing of clinical materials.  

• Act as subject matter expert (SME) across for cleaning validation assays.  

• Communicate and collaborate with production area personnel to understand cleaning activities and provide appropriate analytical support for development testing assays. 

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

• Develop and manage project timelines and deliverables.  

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

• Advance strategic initiatives across matrixed teams.   

• Author and review technical documentation including regulatory submissions.  

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

Qualifications  

• 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.     

Experience and Skills  

Required  

• Proficient in using HPLC, UPLC, conductivity, TOC, LC-MS, and related assays for cleaning validation in analytical procedures. 

• Experience with TQ-S mass spectrometry systems. 

• Deep technical expertise with separation techniques such as HPLC, UPLC, CE, iCIEF, or other advanced technology.  

• Strong organizational skills with proven ability to manage timelines and deliverables.  

• Able to proactively recognize and communicate potential risks.  

• Proven ability to solve technical problems with innovation.  

• Ability to work independently and within a matrixed team.   

• Effective communication (oral and written) and leade