Principal Scientist, PAT

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Description

This is a non-supervisory, technical position in Phlow's R&D and Manufacturing spaces. In this role, the incumbent is responsible for developing Process Analytical Technology (PAT) methods and off-line Analytical Development/Validation methods to support process chemistry development and manufacturing related to active pharmaceutical ingredients (APIs) including continuous and flow processes. This work includes collecting data, building chemometric models, and integrating PAT and analytical method development/validation at the bench scale to monitor and characterize continuous flow processes. The incumbent may execute 60% - 80% of their work at the bench level. They direct, troubleshoot, and share insights on complex projects while drawing independent conclusions about the results and determining how to proceed with the project. They closely collaborate with other scientists and/or other Phlow personnel.

Requirements

• Work with a group of innovative scientists to support process development and manufacturing activities for APIs, as well as analytical troubleshooting.
• Interact closely with manufacturing and external partners in identifying, implementing, and troubleshooting test methods and workflows for ensuring compliant, robust API manufacturing process.
• Develop and validate analytical methods through collaboration to develop at-line and in-line PAT methods and models for assessing the quality of batch and continuous manufacturing processes.
• Provide analytical support to process development groups.
• Perform analyses and method development using a variety of analytical methods such as spectroscopy, chromatography, and mass spectrometry.
• Perform peer-reviews of analytical data and reports.
• Write final reports and prepare slides for presentations.
• Document project progresses, track and report the status of assignments to management on a regular basis.
• Work with cross-functional teams within the organization to solve both technical and process-related issues.
• Demonstrate strong technical skill and expertise in specific laboratory methods and troubleshoot instrumentation within area of expertise.
• Seek out innovative ways to apply knowledge or skills to improve protocols and results.
• Actively engage in overall project and ensure your own work is aligned with overarching goals.
• Share technical expertise with other lab staff and serve as a mentor for them.
• Serve as technical expert and champion for PAT and/or process model building.
• Recommend and implement new approaches or processes to improve laboratory operations.
• Assist lab head in planning, implementing, and evaluating laboratory procedures/systems.
• Attend scientific seminars and conferences and make presentations.
• Help in establishing Quality systems in the laboratory.
• Lead or assist in technology transfer activities.
• Other duties as assigned.

Basic Qualifications

• Principal Analytical Chemist: Ph.D. in chemistry or related field with at least five (5) years of relevant laboratory experience, or an MS in chemistry or related field with ten (10) years of experience or a BS in chemistry or related field with fifteen (15) years of experience
• An equivalent combination of education and experience may substitute.
• Experience in method development and method implementation
• Good technical writing and verbal communication skills are required.
• Good interpersonal skills and process ability to function in a team-oriented environment are necessary.
• Understanding of process analytical technology, chemometrics, and knowledge of in-line process analytical tools.

Preferred Qualifications

• Experience with a wide variety of software and laboratory information systems, including chemometric modeling software
• Pharmaceutical laboratory experience, method development and method implementation in manufacturing environments, and/or continuous manufacturing experience.
• Hands-on experience with and willingness to operate a wide range of analytical instrumentation including, but not limited to HPLC, GC, MS, FTIR spectroscopy, NIR spectroscopy Raman spectroscopy, and associated software.
• Working knowledge in analytical methods development and validation requirements.
• Working knowledge of API manufacturing and product testing, and capacity to collaborate in a cross-functional group.
• Strong project management skills with ability to be effective both independently and in collaborative teams.