Senior Principal Analytical Chemist

ZipRecruiter; Petersburg (VA); On-site; USD 90,000 - 130,000; Full time

Job summary

A leading company in pharmaceutical services is seeking an Analytical Chemist to provide analytical support for contract development and manufacturing. The role entails method development, collaborating with QC, and ensuring compliance with regulatory standards. This position requires extensive experience and a strong background in analytical chemistry techniques, offering an opportunity to influence product development within a values-driven organization.

Qualifications

• Ph.D. with at least 10 years, M.S. with 15 years, or B.S. with 20 years experience in analytical chemistry.
• Broad expertise in analytical chemistry and compound purification.
• Proficiency in techniques such as HPLC, LC-MS, and spectrometry.

Responsibilities

• Conduct analytical method development and validation independently.
• Collaborate with QC department and manage analytical project resources.
• Review, analyze, and interpret data to provide scientific recommendations.

Skills

Analytical Chemistry

Spectral Analysis

Communication

Problem Solving

Interpersonal Skills

Education

Ph.D. in Analytical Chemistry

M.S. in Pharmaceutical Sciences

B.S. in Chemistry

Tools

HPLC

LC-MS

GC-MS

UV Spectroscopy

FTIR

Job description

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 both internal API development and commercial projects. The candidate will embody Phlow’s shared values and culture, maintaining high standards of safety, integrity, transparency, and ethics to create win-win scenarios for patients, customers, partners, and colleagues. While not required, we appreciate your accompanying your application with 1-3 professional references if possible.

Requirements:

Essential Job Duties & Responsibilities:

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

Experience & Qualifications:

1. Advanced degree in chemistry, pharmaceutics, or related field.
2. 15+ years of experience in analytical method development, validation, and API/drug product development activities regulated by FDA.
3. Proficiency with standard Office tools (MS Office, MS Project, Excel, Visio, SharePoint).
4. Ability to work independently and collaboratively.
5. Broad expertise in analytical chemistry, compound purification, spectral analysis/interpretation.
6. Experience with techniques such as HPLC, LC/MS, GC, GC/MS, KF, LOD, DSC, TGA, NMR, UV, LC-MS, Raman, FTIR.
7. Excellent written and verbal communication skills.
8. Strong interpersonal skills.

Qualifications:

1. 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 related fields.
2. Knowledge of ICH and cGMP standards.
3. Experience with contract organizations (CROs/CMOs/CDMOs) is advantageous.
4. Experience with risk assessments like process robustness, mutagenic impurities, nitrosamines, etc., is a plus.
5. Experience with Process Analytical Technology (PAT) development and implementation is a plus.
6. Experience with Design of Experiments (DOE) is beneficial.

Physical Requirements:

• Constantly use computer screens and monitors for reading, writing, and communication.
• Frequently talk or hear for communication and presentations.
• Repetitive motions with arms and hands, primarily at a computer.
• Frequently sit; occasionally stand or walk within an office environment.
• Occasionally lift or move up to 10 pounds.
• Up to 5% travel required, with potential for increased travel based on business needs.