Description Alkermes seeks a highly qualified Senior Scientist for it's ongoing work in the biologics space! This role is responsible for early phase clinical product development, optimization, validation and transfer of complex analytical assays to Quality, in order to support therapeutic proteins using a variety of methods including protein chemistry techniques. The Senior Scientist will be responsible for developing, optimizing, and performing analytical methods to characterize recombinant protein therapeutics using techniques such as high-performance liquid chromatography (HPLC), mass spectrometry (MS), and capillary electrophoresis (CE). The successful candidate will be responsible for planning and the prioritization of multiple projects in a cGMP environment. He or She must have excellent managerial, organizational, and communication skills and will be required to function on multi-disciplinary teams. He/She will also be responsible for drafting SOP’s, validation protocols, technical reports and conducting validation activities in conjunction with QC personnel. The incumbent will also be required to train and mentor junior analysts. Basic Qualifications: Ph.D in Biochemistry, Chemistry or a related field with 8-10 years industrial experience and solid background mass spectrometric techniques, including IonTrap, MALDI-TOF and other MS/MS techniques used to determine detailed structural characterization including post-translational modifications (carbohydrate analyses) of therapeutic proteins. A good understanding and working knowledge of other analytical techniques for protein characterization such as SEC, IEC, RP-HPLC, peptide mapping and capillary electrophoresis is required. He/She must have demonstrated strong organizational and communication skills, managerial responsibilities, and have experience with leading or participating on CMC teams and Regulatory Submissions.
Phama Job Categories:
Research and Development