Our client, a leading Pharmaceutical company is hiring a Scientific Engineering Consultant on a contracting basis.This role is w2 only, we cannot work on C2CWork Location: Cambridge MAJob Description:
This position is in the Analytical Development and Attribute Sciences (ADAS) group of the Biologics Development organization. In collaboration the Mass Spectrometry Center of Excellence within ADAS, this individual will be responsible for the design and hands-on execution of analytical studies to support structural characterization, comparability, forced degradation, formulation development, and other developments activities of biotherapeutics drug candidates at all stages of clinical development as well as commercial.
The role will primarily be focused on application of mass spectroscopic techniques characterization of biotherapeutics and the analytical methods employed to control their quality.
A demonstrated ability to apply mass spectroscopic techniques towards protein characterization at the primary and higher order structural levels is desired.
Expertise in LC-MS/MS techniques applied to the characterization of proteins is required.
Experience with therapeutic proteins including mAb, bispecific antibodies, fusion proteins, antibody drug conjugates and other derivatized proteins.
Familiarity with additional biophysical techniques used in protein characterization is desirable (iCIEF, CE-SDS,size-exclusion, reverse-phase UPLC, and glycan analysis).
A comprehensive understanding of quality attributes, and protein degradation mechanisms as they relate to drug substance and drug product development and quality.
This individual will be required to present and interpret scientific data, lead technical team activities, contribute to IND, IMPD, BLA, and other regulatory filings, write technical reports and represent the department in matrix team meetings when needed.Qualifications:
PhD or Masters degree with a minimum of 3 years, or BS or equivalent with a minimum 5 years, of relevant experience in biopharmaceutical/biotechnology.
Knowledge of biologics and industry experience in biologics research/development
Hands-on experience and expertise in current LC-MS/MS protein analytical methods and techniques
Expertise in protein separation and enrichment sciences and protein structure.
Excellent communication and interpersonal skills, both written and verbal are required. Experience leading matrix team desired.
Works independently and collaborates with other groups in ADT and deliver results in line with project and team objectives
Designs, follows and reviews protocols, scientific methods, and departmental procedures; Organizes and interprets scientific data. Experience in authoring IND, IMPD, BLA, and other regulatory filing documents.
Trains others on procedures, operations and new technology, or methods
Proactive at keeping current with and leveraging literature and latest technologies.Please contact me directly if you are interested in learning more about this opportunity or to discuss our referral program if you know anyone that may be interested.Regards,