Senior Scientist, Analytical Chemistry

Phlow Corp•Richmond, VA

1d•$90,000 - $115,000

About The Position

The Senior Scientist, Analytical Chemistry provides analytical chemistry support to Phlow and its contract development and manufacturing services. The role develops and performs analytical experiments under the direction of the Senior Director, Analytical Chemistry or other team members, supporting internal API development and commercial projects to meet business objectives. The successful candidate is expected to uphold Phlow’s shared values and culture and work with high standards of safety, integrity, transparency, and ethics. The position supports product development and clinical trial material and requires work within assigned timelines and applicable cGXP, regulatory requirements, and company practices and procedures. The role includes independently developing and validating analytical methods, conducting project support, managing analytical project resources and technical direction, producing and interpreting data, and authoring or reviewing technical and regulatory documentation. It also involves designing and conducting studies and managing day-to-day analytical laboratory equipment activities, including consumables, troubleshooting, maintenance, and calibrations. The salary range is $90,000 to $115,000. The position is eligible for Phlow’s bonus and stock option programs. Benefits include medical, life, and disability insurance; retirement savings plans; paid time off and company holidays; and education-related benefits. Some programs are fully funded or significantly subsidized by the company. The position may require up to 5% travel, with occasional increases based on business needs.

Requirements

Advanced degree in chemistry, pharmaceutics, or a related field.
1–3 years of experience in analytical method development, validation, and 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 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, and UV.
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. degree 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 (CROs/CMOs/CDMOs).
Experience with technical and operational risk assessments, such as process robustness, mutagenic impurities, and nitrosamines.
Experience with the development and implementation of Process Analytical Technology (PAT).
Experience with Design of Experiments (DOE).

Responsibilities

Independently conduct analytical method development, validation, and project support.
Identify technical challenges during analytical method development and troubleshoot analytical methods.
Manage CMO/CRO analytical project resources, including contractors and contract laboratories, as needed.
Manage the technical direction of analytical projects, identify key deliverables and next steps, and communicate them to the team.
Produce, review, analyze, and interpret data from a variety of sources; provide accurate summaries and scientifically rigorous recommendations to stakeholders.
Author and review technical reports, regulatory submissions, SOPs, validation protocols, and other cGMP documents.
Perform assigned analytical tasks with minimum supervision in support of product development and clinical trial material.
Perform activities within assigned timelines and in compliance with cGXP requirements, regulatory requirements, and company practices and procedures.
Design and conduct 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 coordinating calibrations with vendors.