Senior Scientist, Synthetic Process Chemistry at AstraZeneca in New Haven, Connecticut

Job Description:

This is what you will do:


Alexion's Product Development and Clinical Supply (PDCS) organization is seeking an innovative organic chemist to serve as a technical expert in drug substance synthetic route design, driving an emerging small molecule portfolio. The Senior Scientist, Synthetic Process Chemistry, will leverage deep chemistry expertise to design safe, scalable, and cost-effective synthetic routes. Responsibilities include route design and development of drug substance processes, with special emphasis on the deployment of advanced synthetic strategies enabled by flow chemistry to deliver enhanced throughput, process safety, and/or product quality.



You will be responsible for:

• Designing safe, scalable, efficient, economical and sustainable synthetic routes and chemical processes to generate active pharmaceutical ingredients.
  
  

• Delivering innovative flow chemistry strategies to enable multi-step continuous manufacturing processes, designing and deploying comprehensive control strategies that leverage online process monitoring technologies, and driving tech transfer of multi-step continuous processes to external manufacturing facilities, in partnership with Alexion engineering, analytical, and QA colleagues.
  
  


• Ensuring that stage-appropriate levels of process and product knowledge are maintained and documented throughout development.
  
  


• Providing technical expertise to enable authoring of drug substance modules for regulatory submission documents that convey phase-appropriate scientific understanding, spanning IND/IMPD through NDA/MAA.
  
  


• Partnering with external manufacturing and QA groups to diagnose and remediate process upsets, support product quality impact assessments, enable root cause analyses, and establish effective CAPAs.
  
  


• Providing expert insights on topics including but not limited to regulatory starting material (RSM) designation, ICH M7 and ICH Q3D control strategy, and process optimization / process redesign strategies to improve COGS.
  
  

You will need to have:

• Ph.D. in organic chemistry with 0-3 years of additional related research experience.
  
  


• Expert hands-on laboratory skills, and strong desire to grow as a research scientist via technical excellence in the laboratory.
  
  


• Working knowledge of the design, development, optimization, and tech transfer of small molecule drug substance manufacturing processes.
  
  


• Working knowledge of flow chemistry and continuous unit operations.
  
  

• Ability to plan complex technical development projects, and remotely manage timelines at CROs/CMOs.
  
  


• Technical expertise and intellectual curiosity to remain abreast of scientific trends in pharmaceutical process chemistry and continuous manufacturing, and evaluate new and emerging technologies.
  
  


• Up to 15% travel, with ability to work independently from remote locations.
  
  


• The duties of this role require periodic work in a laboratory or manufacturing environment. As is typical of such roles, 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 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:

• Prior experience in chemometrics, including use of multivariate data analysis, in situ reaction monitoring, reaction profiling, and development of first-principles process chemistry models.
  
  


• Familiarity with the design, programming, and deployment of workflows for automated / autonomous laboratory experimentation.
  
  


• Expertise with impurity structural elucidation.
  
  


• Expertise in genotoxicity risk assessment per ICH M7.
  
  

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.


AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Apply Now