Description

We are searching for the best talent for a Senior Scientist, Protein Analytical Development, Characterization located in Malvern, PA.

Purpose:
The Therapeutics Development and Supply, Protein Development, Analytical Development organization is recruiting a highly skilled and motivated Senior Scientist to join our Protein Analytical Development Characterization group. The role reports to the Scientific Director within the Characterization group and will lead development, design and execution of mass spectrometry assays in support of product characterization and process development of protein-based therapeutics. The successful candidate will play a key role in advancing innovative analytical technologies and delivering phase-appropriate characterization across clinical development and commercialization to ensure the successful advancement of our therapeutic portfolio.

You will be responsible for:

• Develop, design and perform mass spectrometry assays in support of product characterization and process development activities for protein and protein conjugates.
• Drive innovation by evaluating and implementing emerging analytical technologies to enhance characterization strategies.
• Serve as a key technical contributor on cross-functional project teams, leading scientific discussions and providing analytical expertise to support project objectives.
• Maintain accurate laboratory documentation and author protocols, technical reports, and regulatory-supporting documents in compliance with Good Manufacturing Practice (GMP) requirements.

Requirements

Required:

• Minimum of 4 years’ experience following the completion of a Master’s degree or 0-2 years’ experience following the completion of a PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field is required.
• Hands-on experience with Mass Spectrometry (intact mass analysis, peptide mapping, etc.)
• Experience working with protein/antibody 
   

Preferred:

• Experience with 3rd party MS software (e.g., Protein Matrix, Genedata Expressionist, etc.)
• Experience working with antibody drug conjugate
• Experience working in a GLP/GMP environment
• Experience and understanding of pharmaceutical development CMC and regulatory requirements for protein biologics