Senior Principal Analytical Chemist

Phlow Corp; Petersburg (VA); On-site; USD 80,000 - 130,000; Full time

Job summary

An established industry player is seeking an experienced analytical chemist to provide critical support in method development and validation. This role involves conducting experiments, managing project resources, and ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in analytical chemistry and a strong ability to communicate findings effectively. Join a forward-thinking company that values safety, integrity, and innovation, and play a pivotal role in advancing pharmaceutical development. If you are passionate about making a difference in the healthcare sector, this opportunity is tailored for you.

Qualifications

• 15+ years of experience in analytical method development and validation.
• Expertise in various analytical techniques and instrumentation.
• Strong written and verbal communication skills.

Responsibilities

• Conduct analytical method development, validation, and project support.
• Manage CMO/CRO analytical project resources and ensure compliance.
• Review and analyze data, providing scientific recommendations.

Skills

Analytical Chemistry

Method Development

Validation

Spectral Analysis

Communication Skills

Interpersonal Skills

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 the internal Phlow 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 you accompanying your application with 1-3 professional references if you are able to provide.

Requirements

Essential Job Duties & Responsibilities

• Independently conduct analytical method development, validation, and project support
• Work closely with QC department
• Identify technical challenges during analytical method development and perform troubleshooting
• Manage CMO/CRO analytical project resources such as contractors and contract laboratories, as needed
• Manage technical direction of analytical projects; identify key deliverables and communicate to the team
• Review, analyze, and interpret data from various sources; provide accurate summaries and scientific recommendations
• Identify and implement new techniques and instrumentation to expand capabilities
• Author and review technical reports, regulatory submissions, SOPs, validation protocols, and other cGMP documents
• Perform analytical tasks supporting product development and clinical trial materials with minimal supervision
• Ensure activities are completed within timelines and in compliance with cGXP, regulatory requirements, and company procedures
• Design and conduct studies aligning with company and regulatory standards for new product development
• Manage daily laboratory activities for analytical equipment, including sourcing consumables, troubleshooting, and maintenance

Experience & Qualifications

• Advanced degree in chemistry, pharmaceutics, or related field
• 15+ years of experience in analytical method development, validation, and API or drug product development regulated by FDA
• Proficiency with standard Office tools (MS Office, MS Project, Excel, Visio, SharePoint)
• Ability to work independently and collaboratively
• 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 10 years of experience, M.S. with at least 15 years, or B.S. with at least 20 years in Analytical Chemistry, Pharmaceutical Sciences, or a related field
• Knowledge of ICH and cGMP requirements
• Experience working for CROs/CMOs/CDMOs is a plus
• Experience with risk assessments (e.g., process robustness, mutagenic impurities, nitrosamines)
• Experience with Process Analytical Technology (PAT)
• Experience with Design of Experiments (DOE)

Physical Requirements

• Constant visual requirement to utilize computer screens and monitors
• Frequent talking and hearing to communicate with others and present information
• Frequent repetitive motions with arms and hands, primarily at a computer
• Frequent sitting, occasional standing or walking
• Occasionally lift/move up to 10 pounds
• Up to 5% travel, with potential for increased travel based on business needs