Development Scientist II, Analytical Development and Quality Control

This is what you will do: 

• Lead and 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 must 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 must be able to manage projects independently.  Additional responsibilities may 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. 

You will be responsible for: 

• Leading and performing 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 with the group. 

• Authoring CMC sections for regulatory, technical reports, department-specific protocols and reports, and general operating procedures. Leading the development and authoring of new procedures and work practices. 

• Lead new technology evaluation and independently developing protein characterization strategies. 

• Manage the activities of external research laboratories. 

You will need to have: 

• Deep understanding and extensive hands-on 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; and ability to lead process improvements. 

• The individual must be able to give clear instructions, train, and oversee 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. 

• An understanding of the “big picture” for projects and tasks involved, and prioritize work of self and others accordingly. 

• The duties of this role are conducted in an lab environment.  As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; 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. 

We would prefer for you to have: 

• PhD in Biochemistry, Chemistry or related discipline and 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 biotherapeutic assays. 

• Experience working with CRO’s for developing assays and testing of samples. 

In-person statement for 4 days in the office:
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of four days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.