Development Scientist, Protein Characterization
Posted on Apr 6, 2021 by Alexion Pharmaceuticals
This position is required to perform mass spectrometry characterization of biotherapeutics from discovery to marketed products. The candidate should have an established track record characterizing antibodies, proteins, and peptides by mass spectrometry. This includes, but is not limited to, intact molecular weight analysis, subunit analysis, peptide mapping, modification identification, disulfide bonding analysis, glycan analysis, sequence variant analysis, and other analytical methodologies using HPLC/UPLC ESI-ToF, ESI-Orbitrap, and MALDI-ToF instrumentation.
The candidate should have excellent team, organizational, writing, and presentation skills. In addition, this position is expected to interact regularly with scientific staff in other Research & Development groups as well as Analytical Sciences, Process Development, Manufacturing, Quality Assurance and Quality Control groups. The ability to accurately and independently generate procedures, protocols, reports, and CMC section content for regulatory filings pertaining to protein characterization is a crucial requirement of this position.
The candidate should also have experience working with CRO's for developing assays and testing of samples. The candidate must be able to manage projects independently. Additional responsibilities will include oversee manufacturability of new research molecules, representative on cross-functional process development teams, and training and overseeing some day to day responsibilities of junior scientists.
Protein characterization (method development and analysis) by LC/MS and other methods for monoclonal antibodies and recombinant proteins (50%).
Oversee and train Development Associates to perform assay development and testing for biotherapeutics (20%).
Participate in cross-functional process development teams representing Protein Characterization group (10%).
Authoring CMC sections for regulatory, technical reports, department-specific protocols and reports, and general operating procedures (10%).
New technology evaluation and manage the activities of the external research laboratories (10%).
5+ years in the pharmaceutical or biotech industry.
Deep understanding and extensive hands-on experience with protein characterization by LC/MS. Experience in operating multiple mass spectrometry platforms is required. Some examples include Orbitrap, triple Q-TOF, MALDI, etc.
Must possess a solid understanding of protein chemistry, particularly as related to biotherapeutic development.
Position requires in-depth knowledge of general test methods for testing protein therapeutics including monoclonal antibodies and glycoproteins.
An ideal candidate has experience with assay development, optimization, qualification, and validation for protein therapeutics.
Position requires an overall understanding of instrumentation associated with the protein assays pertaining to biopharmaceuticals.
Knowledge of method development using various instrumentation
Ability to take initiative in problem solving.
Ability to consistently bring independent, scientific approach to method development.
A thorough understanding of GLP and quality guidelines is expected for a successful candidate.
The individual must be able to give clear instructions and to train personal as required on practices within the laboratory. Planning and organizing skills are required to plan, execute and track commitments of the laboratory and to adjust to changing priorities.
High emotional intelligence, excellent interpersonal skills, and strong communication skills are required.
PhD in Biochemistry, Chemistry or related discipline
Experience in analyzing and characterizing proteins and biotherapeutics