Scientist, Biologics - Analytical Research & Development (Onsite)

Job Description

Scientist, Biologics Analytical Research & Development

Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology, we collaborate to discover the next medical breakthrough.

The Biologics Analytical Research & Development department of our Research & Development Division is seeking applicants for a Scientist position available at its Kenilworth, New Jersey research facility. The Scientist is a laboratory-based scientific role tasked with solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of Biologics drug substances and drug products. The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. The qualified candidate will be responsible for development, qualification, implementation, troubleshooting and transfer of analytical methods for monoclonal proteins or other complex therapeutic proteins. Applicants must have effective organizational, multi-tasking, oral/written communications skills, show scientific leadership, and a desire to conduct research and publish. Evidence of strong cross-functional collaboration in an academic or industrial setting is also preferred. 

Qualifications
 

Minimum education required:

• BA/BS in analytical chemistry/biochemistry or related field with a minimum of 3 years experience in the Pharmaceutical Industry, or M.S. with a minimum of 0+ year relevant experience.

Required Experience and Skills: 

• Prior experience in a laboratory environment

• Ability to develop and apply basic principles and scientific concepts to execute work in a laboratory

• Execute routine experiments and data interpretation with appropriate technical guidance

• Ability to operate and troubleshoot analytical methods.

• Understanding of the fundamentals in separations science

• Experience with UPLC/HPLC analysis of biologics (e.g., SEC, RP, IEX) and CE techniques or molecular biology (PCR, DNA extraction) and immunoassay (ELISA, gel electrophoresis) techniques

• Ability to work within overall project timelines to manage prioritization and execution of individual deliverables with appropriate supervision.

• Demonstrated experience working within collaborative team environments.

• Experience in authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications.

Preferred Experience and Skills:

• Past experience working as part of a project team  

• Strong knowledge of protein structure and degradation pathways

• Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein)

• Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles

• Prior experience …