Alexion's Product Development and Clinical Supply (PDCS) organization is seeking an expert synthetic organic chemist to lead our strategic capability build in drug substance continuous processing, for deployment across an emerging small molecule portfolio. The Director, Continuous Process Development, will demonstrate deep expertise in flow chemistry to design safe, scalable, and cost-effective synthetic routes, with a special focus on development and deployment of advanced synthetic strategies enabled by multi-step continuous processing. Responsibilities include designing and developing flow chemistry and related continuous unit operations to enable multi-step continuous drug substance processes, as well as technical leadership for third-party development and manufacturing activities.
You will be responsible for:
Building an innovation ecosystem for development and deployment of advanced manufacturing technologies for Alexion synthetic modalities.
Designing safe and scalable synthetic routes that decrease costs, optimize process efficiency, and enhance product quality.
Driving implementation of multi-step continuous drug substance processes at CMOs, in partnership with Alexion technical, analytical, and QA partners.
Designing comprehensive control strategies for continuous processes, including strategic deployment of online process analytical technologies.
Diagnosing and remediating process upsets, supporting quality impact assessments, and facilitating root cause analyses.
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 Alexion technical experts to formulate integrated and complete CMC control strategies for NDA/MAA.
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 minimum 12 years experience in the pharmaceutical industry.
Demonstrated expertise in flow chemistry, including design and deployment for cGMP continuous processing.
Deep understanding of the design, development, optimization, and tech transfer of small molecule drug substance manufacturing processes.
Familiarity with cGMPs and pharmaceutical regulatory guidances as they pertain to multi-step continuous drug substance manufacturing.
Ability to plan complex technical development projects, and remotely manage timelines at CROs/CMOs.
Technical expertise to remain abreast of the latest scientific trends pertaining to synthetic organic chemistry, and to evaluate emerging process technologies enabling multi-step continuous processes.
Up to 15% travel, with ability to work from remote locations.
The duties of this role may require periodic work in a laboratory or manufacturing environment. As is typical of such roles, employees are required, 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 hands-on experience in the use of online process analytical techniques to accelerate development and enhance control of continuous drug substance manufacturing processes.
Prior experience in chemometrics, including use of multivariate data analysis, in situ reaction monitoring, reaction profiling, and development of first-principles process chemistry models.
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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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.
