Principal Scientist Continuous Process Development

3 weeks ago

New Haven, United States Alexion Pharmaceuticals,Inc. Full time

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 multi-step 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 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 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.D. in organic chemistry with minimum 9 years experience in the pharmaceutical industry.
- Expertise in flow chemistry, including design and deployment for cGMP continuous manufacturing.
- 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.
- 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 multi-step 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 multi-step 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. 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**:

- 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 first-principles 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. 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.

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