Senior Scientist, Process Analytical Technology (PAT)

Phlow Corp•North Chesterfield, VA

5d•$90,000 - $115,000

About The Position

The Senior Scientist, PAT, develops Process Analytical Technology (PAT) methods and off-line analytical development and validation methods to support process chemistry development and API manufacturing, including continuous and flow processes. The work involves collecting data, building chemometric models, and integrating PAT with analytical method development and validation at bench scale to monitor and characterize continuous flow processes. The incumbent may perform 60%–80% of their work at the bench. They direct and troubleshoot complex projects, draw independent conclusions from results, determine next steps, and collaborate closely with scientists and other Phlow personnel. The role supports API process development and manufacturing, analytical troubleshooting, and compliant, robust manufacturing workflows in collaboration with manufacturing teams and external partners. It includes analytical method development and validation; at-line and in-line PAT methods and models; analytical support for process development; use of spectroscopy, chromatography, and mass spectrometry; peer review of analytical data and reports; preparation of reports and presentation materials; and regular project-status reporting to management. The Senior Scientist works with cross-functional teams to address technical and process-related issues, shares technical expertise and mentors laboratory staff, and serves as a technical expert and champion for PAT and/or process model building. The role also involves improving laboratory protocols and operations, assisting the lab head with laboratory procedures and systems, attending and presenting at scientific seminars and conferences, helping establish laboratory quality systems, and leading or assisting technology transfers. Other duties may be assigned. The position offers a salary range of $90,000 to $115,000. The final offer depends on factors including experience, qualifications, skills, and education. The role is eligible for Phlow's bonus and stock option programs and includes a comprehensive benefits package.

Requirements

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

Nice To Haves

Ph.D. with a minimum of 2 years of experience, M.S. with a minimum of 5 years of experience, or B.S. with a minimum of 10 years of experience in Analytical Chemistry, Pharmaceutical Sciences, or a related scientific field.
Knowledge of ICH and cGMP requirements.
Experience working for a contract organization (CRO, CMO, or CDMO).
Experience with technical and operational risk assessments, such as process robustness, mutagenic impurities, and nitrosamines.
Experience developing and implementing Process Analytical Technology (PAT).
Experience with Design of Experiments (DOE).

Responsibilities

Develop PAT methods and off-line analytical development and validation methods for API process chemistry development and manufacturing, including continuous and flow processes.
Collect data, build chemometric models, and integrate PAT and analytical method development and validation at bench scale to monitor and characterize continuous flow processes.
Direct and troubleshoot complex projects, independently interpret results, draw conclusions, and determine project next steps.
Collaborate with scientists, Phlow personnel, manufacturing teams, external partners, and cross-functional teams.
Identify, implement, and troubleshoot test methods and workflows for compliant and robust API manufacturing.
Develop and validate analytical methods, including at-line and in-line PAT methods and models for assessing batch and continuous manufacturing quality.
Provide analytical support to process development groups and perform analyses and method development using spectroscopy, chromatography, mass spectrometry, and other analytical methods.
Peer-review analytical data and reports; write final reports and prepare presentation slides.
Document project progress and regularly track and report assignment status to management.
Troubleshoot laboratory instrumentation and demonstrate expertise in laboratory methods within the area of expertise.
Identify innovative applications of knowledge and skills to improve protocols and results; align individual work with project goals.
Share technical expertise with laboratory staff and mentor them; serve as a technical expert and champion for PAT and/or process model building.
Recommend and implement improvements to laboratory operations.
Assist the lab head in planning, implementing, and evaluating laboratory procedures and systems.
Attend scientific seminars and conferences and make presentations.
Help establish laboratory quality systems.
Lead or assist in technology transfer activities.
Perform other duties as assigned.