Senior Scientist, Process Analytical Technology (PAT)

Phlow; Chesterfield Court House (VA); On-site; USD 90,000 - 115,000; Full time

Benefits offered by this job

Bonus program

Stock options

Medical, life and disability insurance

Retirement savings plan

Paid time off and company holidays

Education-related benefits

Job summary

Phlow in Virginia is seeking a Senior Scientist, PAT to develop Process Analytical Technology (PAT) methods and offline analytical development for APIs, including continuous and flow processes. You will collect data, build chemometric models, and integrate method development/validation at bench scale to monitor continuous manufacturing processes.

The role involves collaboration with manufacturing and external partners, leading technical challenges, performing analyses with spectroscopy,

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.

Responsibilities

• Develop and validate analytical methods for at-line and in-line PAT and quality assessment of batch and continuous manufacturing processes.
• Provide analytical support to process development groups and troubleshoot complex projects.
• Lead documentation, peer-reviews of analytical data and reports, and senior technical guidance for PAT initiatives.

Education

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

Tools

HPLC

LC/MS

GC

GC/MS

KF

LOD

DSC

TGA

NMR

UV

LC-MS

Job description

Description

The Senior Scientist, PAT, 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.

• 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.

The salary range for this position is $90,000 to $115,000, with the final offer determined based on factors such as the candidate's experience, qualifications, skills, and education. In addition to a competitive base salary, this position is eligible to participate in Phlow's bonus and stock option programs. Phlow also offers a comprehensive benefits package that includes medical, life, and disability insurance; retirement savings plans; paid time off and company holidays; and education-related benefits. Many of these programs are fully funded or significantly subsidized by the company, reflecting our commitment to supporting the health, well-being, and professional development of our employees.

Requirements

Experience & 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

Preferred Qualifications

• Ph.D. with a minimum 2 years of experience, M.S with a minimum 5 years of experience, or B.S. degree with a minimum 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 (CROs/CMOs/CDMOs) is a plus.
• Experience with technical and operational risk assessments (e.g., process robustness, mutagenic impurities, nitrosamines, etc.) is a plus.
• Experience with the development and implementation of Process Analytical Technology (PAT) is a plus.
• Experience with Design of Experiments (DOE) is a plus.

Physical Requirements

• Constantly required to see to utilize computer screens and monitors to perform job duties including reading & writing, as well as when presenting information and communicating with others.
• Frequently required to talk or hear to communicate with employees, candidates, vendors, and others, including presenting information in front of groups.
• Frequently required to reach with arms and hands performing repetitive motions and using finger dexterity to work primarily at a computer keyboard and with a mouse.
• Frequently required to sit, and occasionally required to stand or walk to move around primarily in an office environment.
• Occasionally lift and/or move up to 10 pounds.
• This position may require up to 5% travel with occasional increase in travel demands based on business needs.