PAT Scientist

Continuus Pharmaceuticals; Woburn (MA); On-site; USD 120,000 - 155,000; Full time

Job summary

CONTINUUS Pharmaceuticals in Woburn, MA is seeking a PAT Scientist to implement inline/online monitoring techniques, build predictive models for concentration, crystallinity, reaction completion and content uniformity, and to assist with technology transfer to pilot plant/scale-up activities.

The role requires an MS or PhD in Chemistry, Chemical Engineering or related field with a strong background in chemometrics and PAT, plus hands-on experience with vibrational spectroscopies (FTIR, Raman,

Qualifications

• MS or PhD in Chemistry, Chemical Engineering or related field.
• Background in chemometrics / PAT with vibrational spectroscopies (FTIR, Raman, NIR, etc).
• Experience with PAT/Statistical tools and process modelling/simulation to solve complex datasets.

Responsibilities

• Investigate feasibility of inline instruments for in-line monitoring of projects.
• Build predictive calibration models for real-time component analysis.
• Analyze reaction trends from inline data and suggest process parameter adjustments.
• Coordinate instrumentation sharing across projects for optimal tool usage.
• Contribute to SOPs, tech transfer docs, process flow diagrams and regulatory submissions.
• Support automation between PAT tools and process data systems to maintain CPPs and CQAs.

Skills

Chemistry

Chemical Engineering

PAT/Process Analytics

Chemometrics

Education

MS or PhD in Chemistry or Chemical Engineering

Tools

Unscrambler

SIMCA

MATLAB

JMP

PLS Toolbox

Job description

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.

LOCATION25-R Olympia AvenueWoburn, MA

EMPLOYMENT TYPEFull 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\scale-up activities.

Key responsibilities:

• 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.

REQUIRED QUALIFICATIONS:

• 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.

PREFERRED QUALIFICATIONS:

• iC software and instruments from Mettler Toledo (ReactIR, ReactRaman, 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 STATEMENTWe 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.