Scientist/Senior Scientist – Analytical Development
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.
-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
Job Type: Full-time
Salary: $110,000.00 – $130,000.00 per year
-Paid time off
Schedule: Monday to Friday
Ability to commute/relocate:
-Frederick, MD 21701: Reliably commute or planning to relocate before starting work (Required)
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