Senior Scientist, PAT & Process Analytics for APIs

Phlow Corporation; Virginia; On-site; USD 90,000 - 115,000; Full time

Benefits offered by this job

Medical, life, and disability ins.

Retirement savings plans

Paid time off and holidays

Education-related benefits

Job summary

Phlow Corporation is seeking a Senior Scientist, PAT, to develop Process Analytical Technology methods and off-line analytical development techniques supporting API process chemistry development and manufacturing. The role involves bench-scale work, collaboration with manufacturing and external partners, and mentoring other staff.

Responsibilities include method development using spectroscopy, chromatography, and mass spectrometry, data analysis, and model building for batch and continuous

Qualifications

• Advanced degree in chemistry, pharmaceutics, or related field.
• 1-3 years experience in analytical method development, validation, and API and/or drug product development activities regulated by FDA.
• Working knowledge of standard Office tools (MS Office, MS Project, Excel, Visio, SharePoint).
• Ability to work well both independently and with a team.
• Broad range of functional expertise in analytical chemistry, compound purification, spectral analysis/interpretation.
• Experience with common analytical techniques such as: HPLC, LC/MS, GC, GC/MS, KF, LOD, DSC, TGA, NMR, UV, LC-MS.
• Excellent written and verbal communication skills
• Strong interpersonal skills

Responsibilities

• 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 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.

Skills

Analytical method development

FDA-regulated development

Team collaboration

Excellent communication

Analytical chemistry

DOE knowledge

Education

Ph.D. in Analytical Chemistry

M.S. in Chemistry

B.S. in Chemistry

Tools

MS Office

MS Project

Excel

Visio

SharePoint

Job description

Phlow Corporation is seeking a Senior Scientist, PAT, to develop Process Analytical Technology methods and off-line analytical development techniques supporting API process chemistry development and manufacturing. The role involves bench-scale work, collaboration with manufacturing and external partners, and mentoring other staff.

Responsibilities include method development using spectroscopy, chromatography, and mass spectrometry, data analysis, and model building for batch and continuous