What are the responsibilities and job description for the Development Scientist II, Analytical Development and Clinical QC position at Alexion Pharmaceuticals, Inc.?
Job Title: Development Scientist II, Analytical Development and Clinical QC
Introduction to role
Are you ready to lead and perform mass spectrometry characterization of biotherapeutics from discovery to marketed products? We are looking for a candidate with a proven track record in characterizing antibodies, proteins, and peptides by mass spectrometry. This includes 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. If you have excellent team, organizational, writing, and presentation skills, and can interact regularly with scientific staff across various groups, this role is for you!
Accountabilities
Join us in pushing the boundaries of science to deliver life-changing medicines. Apply now!
Introduction to role
Are you ready to lead and perform mass spectrometry characterization of biotherapeutics from discovery to marketed products? We are looking for a candidate with a proven track record in characterizing antibodies, proteins, and peptides by mass spectrometry. This includes 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. If you have excellent team, organizational, writing, and presentation skills, and can interact regularly with scientific staff across various groups, this role is for you!
Accountabilities
- Lead and perform protein characterization (method development and analysis) by LC/MS.
- Oversee and train associates to perform method development and analysis by LC/MS.
- Participate in cross-functional development teams representing the Protein Characterization group and lead scientific/technical problem-solving efforts.
- Author CMC sections for regulatory filings, technical reports, department-specific protocols, and general operating procedures.
- Lead the development and authoring of new procedures and work practices.
- Evaluate new technologies and independently develop protein characterization strategies.
- Manage the activities of external research laboratories.
- Deep understanding and extensive direct experience with protein characterization by LC/MS using multiple mass spectrometry instruments and platforms.
- Ability to lead problem-solving activities and bring independent, scientific approaches to method development.
- A thorough understanding of GLP and quality guidelines; ability to lead process improvements.
- Ability to give clear instructions, train, and oversee personnel as required on practices within the laboratory.
- Planning and organizing skills to plan, execute, and track commitments of the laboratory and adjust to changing priorities.
- Understanding of the “big picture” for projects and tasks involved, prioritizing work of self and others accordingly.
- Ability to work comfortably in a controlled environment with biological, infectious, and hazardous materials; lift/carry 15/30 pounds unassisted/assisted; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem-solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
- PhD in Biochemistry, Chemistry or related discipline with a minimum of 2-5 years related experience.
- In-depth knowledge of charge variant analysis.
- In-depth knowledge of additional non-MS methods and instrumentation for testing biotherapeutics.
- Experience with development, optimization, qualification, and validation of biotherapeutic assays.
- Experience working with CROs for developing assays and testing samples.
Join us in pushing the boundaries of science to deliver life-changing medicines. Apply now!
