Senior Analytical Chemist, Method Development & Compliance

Phlow; Richmond (VA); On-site; USD 90,000 - 115,000; Full time

Job summary

Phlow seeks an analytical chemist to provide analytical support for API development and manufacturing projects. You will develop and validate analytical methods under guidance, troubleshoot challenges, and ensure data quality across cGMP studies.

The role involves collaboration with cross-functional teams, handling instrument maintenance, and contributing to regulatory documentation. A strong background in HPLC, LC-MS, GC, NMR, and related techniques is preferred.

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 Projects, 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

• Independently conduct analytical method development, validation, and project support
• Identify technical challenges during analytical method development and perform analytical method troubleshooting.
• Manage CMO/CRO analytical project resources as required such as contractors and contract laboratories, as needed.
• Manage technical direction of analytical projects; identify key deliverables and next steps and communicate to the team.
• Responsible for data production, review, analysis, and interpretation from a variety of sources. Provide accurate summaries and make recommendations to stakeholders with scientific rigor.
• Author and review technical reports, regulatory submissions, SOPs, validation protocols, and other cGMP documents.
• Performs the assigned analytical tasks with minimum supervision in support of product development and clinical trial material.
• Performs activities within the assigned timelines and in compliance with cGXP's, regulatory requirements, and company practices and procedures.
• Responsible for the design and conduct of studies in accordance with company and regulatory standards to facilitate new product development.
• Manage day-to-day laboratory activities for analytical equipment, including sourcing consumables, troubleshooting, maintaining equipment and calibrations with various vendors.

Skills

Analytical chemistry

Data analysis

Scientific writing

Communication

Teamwork

Education

PhD in Chemistry

MS in Chemistry

BSc in Chemistry

Tools

HPLC

LC-MS

GC

NMR

KF

DSC

TGA

UV-Vis

LC-MS

Job description

Phlow seeks an analytical chemist to provide analytical support for API development and manufacturing projects. You will develop and validate analytical methods under guidance, troubleshoot challenges, and ensure data quality across cGMP studies.

The role involves collaboration with cross-functional teams, handling instrument maintenance, and contributing to regulatory documentation. A strong background in HPLC, LC-MS, GC, NMR, and related techniques is preferred.