Alexion's Product Development and Clinical Supply (PDCS) organization is seeking an innovative expert in process analytical technology (PAT) & chemometrics to enable development, optimization, monitoring, and control of continuous processes for the manufacture of synthetic drug substances. The Principal Scientist, Process Analytical Technology & Chemometrics, will leverage deep analytical expertise to deploy a comprehensive suite of on-line and at-line analytical tools in support of a small molecule portfolio focused on rare and ultra-rare diseases. Responsibilities include deployment of on-line analytical tools to enable synthetic strategies with emphasis on flow chemistry and continuous processing, delivering enhanced throughput, improved product quality, and/or decreased product costs.
You will be responsible for:
Deployment of a diverse range of process analytical technologies (PAT) to develop, optimize, monitor, and control pharmaceutical processes, with emphasis on continuous processes.
Establishing workflows to seamlessly collect, interpret, utilize and visualize analytical data. These workflows should enable real-time application of analytical data to process optimization and process control strategy.
Partnering with scientists and engineers engaged in the development of continuous manufacturing processes, leveraging data-rich experimentation to drive innovation and process improvements.
Partnering with CMOs to transfer appropriate on-line monitoring tools and associated methods in support of clinical and commercial manufacturing.
Providing technical expertise to enable authoring of regulatory submission documents that convey phase-appropriate scientific understanding, spanning IND/IMPD through NDA/MAA.
You will need to have:
Degree in analytical chemistry, organic chemistry, or related scientific field (chemical engineering, data science, etc.) with relevant hands-on academic and/or industry experience in advanced process analytical technologies & chemometrics (PhD: 9+ years experience, MS: 12+ years experience).
Extensive knowledge and hands-on experience with on-line analytics and process analytical technology, including on-line HPLC, FTIR, Raman, etc.
Proven ability to design, execute, and interpret data-rich experiments.
Expert hands-on laboratory skills, and strong desire to grow as a research scientist via technical excellence in the laboratory.
Working knowledge of flow chemistry and continuous unit operations.
Technical expertise and intellectual curiosity to remain abreast of scientific trends in pharmaceutical process chemistry, and to evaluate new and emerging on-line analytical 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:
Hands-on chromatography (e.g.,LC, GC) method development experience.
Prior experience with on-line monitoring tools for continuous direct compression tableting processes , especially NIR or Raman.
Demonstrated expertise in PAT method development, optimization, and use of multivariate data analysis / chemometrics (MVDA, PCA, PLS)
Good understanding of theoretical and experimental approaches to develop and implement enhanced control strategies
Experience with analytical strategies to enable high-throughput experimentation / parallelization / miniaturization
Good understanding of the drug development and commercialization process, from discovery through product launch and lifecycle management
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.
