Scientist/Senior Scientist – Analytical Development

Job Summary:

Beyond a Resume is seeking a Senior Scientist with Analytical Development experience. A qualified Senior Scientist candidate will preferably possess an advanced degree (master or doctorate) in the life sciences with relevant skills and bench experience preferably in a GMP industry setting. The selected candidate will play a significant role in development and execution of physicochemical testing supporting both biosimilar and innovative product development.

These activities include the development and qualification of a variety of assays for comparing and ensuring product quality attributes such as:

-Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) method development and testing of protein drug candidates and samples with a focus on characterization of monoclonal antibody (mAb) therapeutics.

-LC-MS/MS analyses will include methods to analyze intact and digested mAb as well as analysis of N-glycans.

-HPLC-based analytical methods such as SEC-HPLC, CEX-HPLC, HIC-HPLC, Affinity Chromatography, etc.

-CE-based analytical methods such as CE-SDS and cIEF.

-Deep knowledge of and experience with analytical method qualification/validation and current

-Good Manufacturing Practices (cGMP) and experience writing analytical method SOPs and development reports are desired

-Experience with design of experiments (DOE) is a plus.

-Excellent communication skills and the ability to analyze and interpret data, design appropriately controlled experiments, and maintain up-to-date documentation are a must.

-Experience in the preparation and delivery of oral and written presentations as well as participation in the preparation and submission of regulatory applications and/or manuscripts for publication are required.

Job Qualifications:

-Masters/Doctoral degree in life sciences preferred

-Hands on experience in characterization of biotherapeutic products (Scientist: a minimum of 2 years of relevant experience; Senior Scientist: a minimum of 5 years of relevant experience)

-Experience with current Good Manufacturing Practices (cGMP) and Good

-Documentation Practices (GDP) is desired

-Excellent time management and proven ability to complete projects on time

-Excellent level of initiative and quest for knowledge

-Must be organized and self-motivated

-Must have excellent communication and technical writing skills

Salary based off experience