Principal Scientist Continuous Process Development - New Haven, United States - Alexion Pharmaceuticals,Inc.
Description
Location:
New Haven, United States
Job reference:
R-199822
Date posted: 05/16/2024
This is what you will do:
You will be responsible for:
- Designing safe and scalable synthetic routes that decrease costs, optimize process efficiency, and enhance product quality.
- Designing multistep continuous drug substance manufacturing processes and overseeing their implementation at CMOs, in partnership with Alexion technical, analytical, and QA partners.
- Designing comprehensive process control strategies for continuous manufacturing, including strategic deployment of online process analytical technologies.
- Diagnosing and remediating process upsets, supporting quality impact assessments, and facilitating root cause analyses.
- Ensuring that stageappropriate 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 phaseappropriate scientific understanding, spanning IND/IMPD through NDA/MAA.
- Partnering with Alexion technical experts to formulate integrated and holistic 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.
- Expertise in flow chemistry, including design and deployment for cGMP continuous manufacturing.
- Proven ability to design, execute, and interpret datarich experiments.
- Expert handson laboratory skills, and strong desire to grow as a research scientist via technical excellence in the laboratory.
- Understanding of the design, development, optimization, and tech transfer of small molecule drug substance manufacturing processes.
- Familiarity with cGMPs and pharmaceutical regulatory guidance as they pertain to multistep continuous drug substance manufacturing.
- Ability to manage 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 multistep continuous processes.
- Up to 15% travel, with ability to work independently from remote locations.
- The duties of this role may require periodic work in a laboratory or manufacturing environment.
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 firsthand experience (academic or industrial) 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 firstprinciples process chemistry models.
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.
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