Principal Analytical Chemist

Phlow Corp; Petersburg (VA); On-site; USD 80,000 - 120,000; Full time

Job summary

An innovative company is seeking an experienced analytical chemist to provide critical support for contract development and manufacturing services. This role involves conducting method development, validation, and project support while ensuring compliance with regulatory standards. The ideal candidate will possess a strong background in analytical chemistry, with expertise in various techniques and instrumentation. This position offers a collaborative environment where your contributions can significantly impact product development and clinical trials. If you are passionate about advancing analytical methods and thrive in a dynamic setting, this opportunity is perfect for you.

Qualifications

• 10+ years of experience in analytical method development and FDA-regulated activities.
• Strong expertise in analytical chemistry and compound purification techniques.

Responsibilities

• Conduct analytical method development and validation independently.
• Manage analytical project resources and provide technical direction.

Skills

Analytical Chemistry

Method Development

Validation

Data Analysis

Communication Skills

Problem Solving

Education

Ph.D. in Chemistry or related field

M.S. in Chemistry or related field

B.S. in Chemistry or related field

Tools

HPLC

LC/MS

GC

GC/MS

MS Office

Job description

The purpose of this role is to provide analytical chemistry support to Phlow. This is an exciting opportunity for individuals with analytical chemistry experience to develop and perform analytical experiments under the direction of the Director, Analytical Chemistry or other team members. The candidate will support Phlow's contract development and manufacturing services to ensure business objectives are met for internal API development as well as commercial projects. The candidate will embody Phlow's shared values and culture, both internally and externally, working with high standards of safety, integrity, transparency, and ethics to create win-win scenarios for patients, customers, partners, and colleagues. While not required, we appreciate applicants accompanying their application with 1-3 professional references if available.

Requirements

Essential Job Duties & Responsibilities

1. Independently conduct analytical method development, validation, and project support.
2. Identify technical challenges during analytical method development and troubleshoot accordingly.
3. Manage CMO/CRO analytical project resources such as contractors and contract laboratories as needed.
4. Provide technical direction for analytical projects, including identifying key deliverables and next steps, and communicating effectively with the team.
5. Review, analyze, and interpret data from various sources, providing accurate summaries and scientific recommendations to stakeholders.
6. Identify and implement new techniques and instrumentation to expand internal capabilities.
7. Author and review technical reports, regulatory submissions, SOPs, validation protocols, and other cGMP documents.
8. Perform assigned analytical tasks with minimal supervision to support product development and clinical trial materials.
9. Ensure activities are completed within timelines and in compliance with cGXP, regulatory standards, and company procedures.
10. Design and conduct studies following company and regulatory standards to facilitate new product development.
11. Manage daily laboratory activities for analytical equipment, including sourcing consumables, troubleshooting, and maintaining equipment and calibrations with vendors.

Experience & Qualifications

• Advanced degree in chemistry, pharmaceutics, or a related field.
• 10+ years experience in analytical method development, validation, and API or drug product development activities regulated by the FDA.
• Proficiency with standard Office tools (MS Office, MS Project, Excel, Visio, SharePoint).
• Ability to work independently and collaboratively within a team.
• Broad expertise in analytical chemistry, compound purification, spectral analysis/interpretation.
• Experience with techniques such as HPLC, LC/MS, GC, GC/MS, KF, LOD, DSC, TGA, NMR, UV, LC-MS, Raman, FTIR.
• Excellent written and verbal communication skills.
• Strong interpersonal skills.

Preferred Qualifications

• Ph.D. with at least 5 years of experience, M.S. with at least 10 years, or B.S. with at least 15 years in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
• Knowledge of ICH and cGMP standards.
• Experience working with CROs, CMOs, or CDMOs is a plus.
• Experience with risk assessments like process robustness, mutagenic impurities, nitrosamines, etc., is a plus.
• Experience with Process Analytical Technology (PAT) development and implementation is a plus.
• Experience with Design of Experiments (DOE) is a plus.

Physical Requirements

• Constant visual focus on computer screens for reading, writing, and communication.
• Frequent talking and hearing for communication with colleagues, vendors, and presentations.
• Repetitive motions with hands and fingers for computer work.
• Frequent sitting, with occasional standing or walking in an office environment.
• Occasional lifting of up to 10 pounds.

This role may require up to 5% travel, with potential increases based on business needs.