Principal Scientist, Small Molecule and Synthetic Peptide Analytical & Control Strategy Development at AstraZeneca in New Haven, Connecticut

Job Description:

Are you ready to make a significant impact on the lives of patients worldwide?


Join Alexion's Synthetic Product Development (SPD) organization as an experienced analytical and control strategy development leader. You will be delivering phase-appropriate control strategies for Alexion small molecule and synthetic peptide programs spanning preclinical development through first commercial launch. This is your chance to define an outstanding career in a leading biotech company with the security and investment of a global pharma.


As a Principal Scientist, you will guide the development, optimization, and validation of analytical methods for small molecule and synthetic peptide drug substances and drug products at CROs/CDMOs. You will propose scientifically sound, phase-appropriate specifications for starting materials, synthetic intermediates, drug substances, and drug products. Additionally, you will author compelling responses to health authority queries on regulatory submission documents and represent Alexion as a subject matter expert in meetings with health authorities.


Essential Skills/Experience:


• Ph.D. in analytical chemistry, bioanalytical chemistry, or a related field with minimum 8 years proven experience in analytical and control strategy development for small molecules and synthetic peptides


• Solid understanding of current regulatory guidelines and cGMP requirements pertaining to small molecules and synthetic peptides


• Strong experience in preparing regulatory submissions for small molecules, synthetic peptides and responding to inquiries from health authorities


• Proven record of leading sophisticated technical development projects, and remotely leading development timelines at CROs/CDMOs


• Technical expertise and intellectual curiosity to remain abreast of the latest developments pertaining to small molecule and synthetic peptide control strategy, and to proactively evaluate emerging technologies and regulatory trends


• Strong understanding of the design, development, optimization, and scale-up of small molecule and synthetic peptide manufacturing processes


• Up to 10% travel, with ability to work independently from remote locations


• Experience with online process analytical techniques to accelerate development and enable enhanced control strategies for multi-step continuous manufacturing processes


• Experience with Chemometrics, multivariate data analysis, in situ reaction monitoring and reaction profiling


• Experience in a biotech or pharmaceutical environment


• Familiarity with global regulatory guidelines


• Proven track record to work collaboratively in a team environment


When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, Four to Five 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.


At AstraZeneca's Alexion business area, we are truly unique in R&D and healthcare. Our closeness to patients brings us closer to our work and closer to each other. Combined with our brave, pioneering spirit - we are a beacon in the global Biopharmaceutical landscape. Here, your career is not just a path, but a journey to making a difference where it truly counts. People living with rare diseases and devastating conditions are our inspiration and our guiding star. We believe it is our responsibility to listen to, understand and change the lives of patients and those who work tirelessly to help them!


Ready to make an impact? Apply now!


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.