Bioassay Scientist, Analytical Research and Development

Job Description

Position Description:

Bioassay Scientist, Analytical Research and Development

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 Scientist in Biologics Analytical Research & Development (AR&D) GMP Operations, to support ELISA and cell-based methods.

In this role, the selected candidate will be responsible for method optimization, phase-appropriate validation, early and late-stage transfers, SoftMax Pro template validation, 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. 

• critical reagent qualifications and SoftMax pro template validation activities.  

• Document activities in a detailed and organized manner following ALCOA principals and SOPs.   

• Author and review technical documents. 

• Complete assigned work within established project timelines.  

• Support GMP compliance and continuous improvement of laboratory operations. 

• Manage laboratory supplies and critical reagent inventories.  

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

Position Qualifications: 

Education Minimum Requirement:

• B.A./B.S. degree in biology, biochemistry, or related scientific field with 3 years of relevant experience in analytical development, validation, and/or quality control,

• or M.S. degree.   

Required Experience and Skills:

•  Technical expertise in immunoassays and/or cell-based potency methods. 

• Experience with mammalian cell culture and ELISAs. 

• …