Development Scientist II, Analytical Development & Clinical Quality Control

This is what you will do:

• Perform characterization of biotherapeutics from research to commercial products.  The candidate should have an established history characterizing antibodies, proteins, and peptides by various analytical techniques; including running, developing, and troubleshooting. Assays include, but are not limited to: HPLC/UPLC, CE-SDS, icIEF, and fraction collection. 
• The candidate should have good 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, comparability, and CQAs is a crucial requirement of this position.
• The candidate must be able to manage projects independently.  Additional responsibilities may include being a 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 comparability and forced degradation studies.
• Leading and performing protein variant (e.g., charge and size) enrichment, fractionation, and characterization.
• 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 innovative technology evaluation and independently developing protein characterization strategies.
• Conduct experimental studies to develop, and optimize analytical/characterization methods for biotherapeutic candidates.

You will need to have:

• Familiar with investigating PTMs and other protein properties with analytical and characterization-based assays
• Direct experience with analytical HPLC/UPLC, CE-SDS, icIEF, and fraction collection.
• Good understanding and direct experience with protein characterization.
• Understanding of comparability and forced degradation studies. Understanding of CQA assessments.
• Ability to take initiative in problem solving and bring independent, scientific approach to method development. 
• A thorough understanding of GLP and quality guidelines.
• 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 people skills, and effective communication skills.
• 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:

• BS or MS in Biochemistry or Chemistry with 10 years’ experience in the biopharmaceutical industry or PhD in Biochemistry or Chemistry and 2-5 years related experience.
• Some knowledge of MS methods and instrumentation for testing biotherapeutics.
• Some experience with assay development, optimization, qualification, and validation for biotherapeutics.

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.