PAT Scientist

ABOUT CONTINUUSCONTINUUS Pharmaceuticals is a spin-out company from the Novartis-MIT Center for Continuous Manufacturing. We design and develop innovative continuous manufacturing processes for pharmaceutical clients, providing an exceptional “one-stop solution” for the entire drug development and manufacturing cycle.

Rather than producing medicines through traditional batch processes, CONTINUUS offers a breakthrough Integrated Continuous Manufacturing (ICM) technology for small molecule drugs.

The synthesis of the active pharmaceutical ingredient and final dosage form are integrated into a seamless and completely automated process. This novel method will allow “on-demand”manufacturing of pharmaceuticals with significant advantages in production lead time, quality, and cost.

Our pipeline is rapidly growing, with exciting projects with pharmaceutical and generic companies, where we will leverage our novel ICM platform to produce low-cost, high-quality drugs for patients worldwide. Essential to our evolution will be talented new team members who will contribute greatly to this mission. We look forward to meeting you.

LOCATION
25-R Olympia Avenue Woburn, MA

EMPLOYMENT TYPE

Full Time - U.S.

-based

JOB TITLE:

PAT Scientist

JOB DESCRIPTION:

At CONTINUUS, a PAT Scientist implements various inline/online techniques / instrumentations / spectrometers to monitor and understand the process insight of reaction conditions, to build suitable predictive models for critical parameters (i.e., concentration, crystallinity, reaction completion, content/blend uniformity) and to help technology transfer to pilot plant cale-up activities.

• Investigate feasibility of instruments to use in in-line monitoring of each (or assigned) project for each step/unit operation.
• Build predictive calibration models for real-time monitoring of component analysis of the step/reaction, and modify these models as needed if changes are made for the process conditions (i.e., solvent change, route change).
• Analyze and report reaction trends from each experiment that is implemented in-line/online/at-line monitoring using various techniques and provide suggestions to control or change process parameters/conditions.
• Coordinate instrumentations between different projects to allow equal usage of available tools for project specific needs.
• Author or contribute to technical documents including SOPs, technology transfer documents, process flow diagrams, regulatory submissions, patents, and scientific papers.
• Support automation developments (i.e., integrated control systems) between PAT tools and process data systems (i.e., syntQ or other systems) to maintain the process control for critical process parameters (CPPs) and critical quality attributes (CQAs) to support the realtime release testing from upstream to downstream processing units.

• A MS or PhD in Chemistry, Chemical Engineering or related field with a background in
• chemometrics / PAT with a strong focus on the application of vibrational spectroscopies (including but not limited to FTIR, Raman, particle size, and NIR, etc)
• Demonstrated experience with PAT/Statistical tools (i.e., Unscrambler, SIMCA, MATLAB/Eigenvector PLStoolbox, JMP etc), process modelling, simulation principles (Dynochem) with the ability to solve complex rich datasets and problems.

• iC software and instruments from Mettler Toledo (ReactIR, React Raman, Particle Track
• FBRM, etc.) with hands-on experience.
• Understanding of safety protocols, Good Laboratory Practices (GLP), Good
• Documentation Practices (GDP), ICH guidelines, and USP requirements
• Crystallization experience a plus
• Familiarity with Electronic Notebooks (ELN)
• Excellent written and verbal communications skills
• Ability to work well in cross-functional teams

EEO STATEMENT We are an Equal Opportunity Employer - all qualified applicants will receive consideration without regard to race; color; religion; sexual orientation or transgender status; gender identity or expression; pregnancy or related medical conditions; workplace hazards to reproductive systems;national origin and ancestry; age; veteran status; current physical or mental disability or history of; intellectual or learning disability; genetic information; homelessness status;

sexual harassment; marital or civil union status; lawful activity outside of the workplace such as tobacco use; or any other characteristic protected by law.