Preferred candidates will have (M.S or Ph.D) in the life sciences with relevant skills and bench experience preferably in a GMP industry setting. The selected candidate will lead all mass spectrometry and related analytical activities to support 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 bottom-up peptide mapping approaches.
- LC-MS/MS analytical methods will also include the analysis of released
- HPLC analytical methods that either support MS analyses or parallel certain assays such as FLD detection and MS/MS detection of HILIC HPLC separation of released and labeled
- Responsibilities may also include management of all outsourced high order structure (HOS) analytics to support biosimilar and innovative product development.
- Experience on an Agilent 6545XT Q-TOF/1290 U-HPLC LC-MS/MS system is highly
- 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 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
- Masters/Doctoral degree in life sciences preferred
- Hands on experience in mass spectrometry protein bioanalytics (minimum 5-7 years)
- Experience with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
- 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