Senior Principal Scientist, Gene Editing Analytical & Control Strategy Development

Introduction to role:

Join Alexion’s Synthetic Product Development (SPD) organization as an experienced analytical and control strategy development leader. The Senior Principal Scientist, Analytical & Control Strategy Development, will deliver phase-appropriate control strategies for Alexion gene editing programs encompassing mRNA, gRNA, and lipid nanoparticles (LNP) spanning preclinical development through first commercial launch! This is an outstanding opportunity to make a significant impact on the lives of patients with rare diseases.

Accountabilities:

As a Senior Principal Scientist, you will guide the development, optimization, and validation of analytical methods for mRNA, gRNA, ionizable lipids, and LNP products at CROs/CDMOs. You will propose scientifically sound, phase-appropriate specifications and deliver comprehensive strategies for impurity characterization and qualification. You will also provide analytical control strategy expertise to enable Module 3 authoring of regulatory submission documents that convey phase-appropriate scientific understanding, spanning IND/IMPD through commercial licensure.

Essential Skills/Experience:

• Ph.D. in analytical chemistry, biochemistry, bioanalytical chemistry, or a related field with minimum 12 years industry experience in analytical and control strategy development for gene editing programs
• Solid understanding of current regulatory guidelines and cGMP requirements pertaining to gene editing
• Strong experience in preparing regulatory submissions for gene editing programs and responding to inquiries from health authorities
• Proven record of leading sophisticated technical development projects, and remotely managing development timelines at CROs/CDMOs
• Technical expertise and intellectual curiosity to remain abreast of the latest developments pertaining to gene editing control strategy, and to proactively evaluate emerging technologies and regulatory trends.
• Strong understanding of the design, development, optimization, and scale-up of mRNA, gRNA, and LNP manufacturing processes
• Up to 10% travel, with ability to work independently from remote locations
• Prior firsthand experience in delivering phase-appropriate control strategies for siRNA and/or ASO therapeutics spanning clinical through commercial launch, including Module 3 authoring for NDA/MAA submissions and responses to health authority queries
• Experience with online process analytical techniques to accelerate development and enable enhanced control strategies for multi-step continuous manufacturing processes

When we put unexpected teams in the same room, we unleash 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, a minimum of 4 -5 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 Alexion, AstraZeneca Rare Disease, we are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and closer to each other. Combined with our brave, pioneering spirit – we are truly unique in R&D and healthcare. We champion diversity and inclusion so that life-changing new ideas can come from everywhere. We celebrate and reward each other, ensuring kindness remains as important as our ambition to succeed for those in need. We take pride in giving back to the communities in which we operate.

Are you ready to make an impact? To drive change with integrity? To join a culture that celebrates diversity, innovation, and the power of connection to patient’s lived experiences? If this sounds like a team that you want to be a part of... then we’d love to talk. 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.