Senior Principal Scientist, Synthetic Peptide Process Chemistry

This is what you will do:

Alexion's Synthetic Product Development (SPD) organization is seeking an expert synthetic organic chemist to lead our strategic capability build in peptide process chemistry, supporting an emerging clinical development portfolio of synthetic peptides. The Senior Principal Scientist will demonstrate deep expertise in peptide process chemistry to design safe, scalable, and cost-effective drug substance manufacturing processes for Alexion synthetic peptide programs spanning preclinical development through first commercial launch, with a special focus on development and deployment of advanced synthetic technologies.

You will be responsible for:

• Building an innovation ecosystem for the development and deployment of advanced manufacturing technologies for Alexion synthetic peptides

• Designing safe and scalable synthetic peptide manufacturing processes that decrease costs, optimize process efficiency, and enhance product quality

• Designing phase-appropriate control strategies for synthetic peptide drug substance manufacturing processes

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

• Providing technical stewardship for external manufacturing campaigns

• 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

• Authoring sound and compelling responses to health authority queries on regulatory submission documents, and representing Alexion as a subject matter expert in meetings with health authorities as necessary

• Providing expert insights on topics including but not limited to ICH M7, ICH Q3D, ICH Q3C, and nitrosamine control strategies, and process redesign strategies to improve COGS

You will need to have:

• Ph.D. in organic chemistry or related field with minimum 12 years proven experience in the pharmaceutical industry, and minimum 8 years direct experience in synthetic peptide process development

• Proven expertise in the design of cGMP peptide synthetic processes, including in-depth knowledge of solid-phase and solution-phase synthesis strategies

• Deep understanding of the design, development, optimization, and tech transfer of synthetic peptide drug substance manufacturing processes

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

• Proficiency in applying analytical instruments, such as HPLC, MS, NMR, for the characterization and analysis of synthetic peptides

• Ability to design, implement, and interpret data-rich experiments!

• Familiarity with cGMPs and pharmaceutical regulatory guidances as they pertain to synthetic peptide drug substance manufacturing

• Ability to manage complex technical development projects and remotely manage timelines at CROs/CDMOs

• Intellectual curiosity to remain abreast of the latest scientific and regulatory trends pertaining to synthetic peptide process chemistry, and technical expertise to evaluate emerging process technologies

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

• Employees are required with or without accommodation to frequently lift/carry 15/30 pounds unassisted/assisted; stand for prolonged periods of time; walk and move for prolonged periods of time; climb stairs or ladders; gown/degown PPE. In addition, employees in this role must pass a medical evaluation; wear a respirator while maintaining a tight-fitting seal to the face.

We would prefer for you to have:

• Experience with technology transfer, scale-up, and cGMP implementation of solid phase peptide synthesis and/or solid phase oligonucleotide synthesis at external manufacturing sites

• Experience with continuous manufacturing technologies, applied to the manufacture of synthetic peptides

• Established scientific reputation in synthetic peptide and/or oligonucleotide process chemistry supported by publications and external presentations

Expectation of working in the office 4 days a week statement: 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.