Senior Scientist, Analytical Chemistry

Phlow Corp; Richmond (VA); Vor Ort; USD 90.000 - 115.000; Vollzeit

Benefits dieser Stelle

Bonus program

Stock options

Medical insurance

Retirement plan

Paid time off

Company holidays

Zusammenfassung

Phlow Corp in Richmond, VA, seeks an analytical chemistry professional to support method development, validation, and project execution for API development and drug products.

The role involves independent experiments, data analysis, and regulatory documentation under senior leadership, with exposure to cGXP requirements and collaboration across sites and vendors.

Qualifikationen

• 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 Project, 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 HPLC, LC/MS, GC, GC/MS, KF, LOD, DSC, TGA, NMR, UV, LC-MS.
• Excellent written and verbal communication skills
• Strong interpersonal skills

Aufgaben

• Independently conduct analytical method development, validation, and project support.
• Identify technical challenges during analytical method development and perform troubleshooting.
• Manage CMO/CRO analytical project resources as required.
• Manage technical direction of analytical projects; identify key deliverables and next steps.
• Responsible for data production, review, analysis, and interpretation from various sources and provide summaries to stakeholders.
• Author and review technical reports, regulatory submissions, SOPs, validation protocols, and other cGMP documents.
• Perform analytical tasks with minimum supervision in support of product development and clinical material.
• Work within timelines and in compliance with cGXP and regulatory requirements.
• Design and conduct studies to facilitate new product development.
• Manage day-to-day lab activities for analytical equipment and vendors.

Kenntnisse

Analytical chemistry

HPLC

LC-MS

GC

NMR

UV

Spectral analysis

DOE

PAT

cGXP

Ausbildung

PhD in Analytical Chemistry

MS in Chemistry

BS in Chemistry

Tools

MS Office

MS Project

Excel

Visio

SharePoint

Jobbeschreibung

Description

The purpose of this role is to provide analytical chemistry support to Phlow. This is an exciting opportunity for graduates or individuals with analytical chemistry experience to develop and perform analytical experiments under the direction of the Senior 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 execution of the internal Phlow API development as well as commercial projects. The candidate will personify Phlow’s shared values and culture, both internally and externally. The candidate will work with the highest standards of safety, integrity, transparency, and ethics to create win-win scenarios for patients, customers, partners, and colleagues.

Requirements

• 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.

The salary range for this position is $90,000 to $115,000, with the final offer determined based on factors such as the candidate's experience, qualifications, skills, and education. In addition to a competitive base salary, this position is eligible to participate in Phlow's bonus and stock option programs. Phlow also offers a comprehensive benefits package that includes medical, life, and disability insurance; retirement savings plans; paid time off and company holidays; and education-related benefits. Many of these programs are fully funded or significantly subsidized by the company, reflecting our commitment to supporting the health, well-being, and professional development of our employees.

Experience & 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 Project, 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

Preferred Qualifications

• Ph.D. with a minimum 2 years of experience, M.S with a minimum 5 years of experience, or B.S. degree with a minimum 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) is a plus.
• Experience with technical and operational risk assessments (e.g., process robustness, mutagenic impurities, nitrosamines, etc.) is a plus.
• Experience with the development and implementation of Process Analytical Technology (PAT) is a plus.
• Experience with Design of Experiments (DOE) is a plus.

Physical Requirements

• Constantly required to see to utilize computer screens and monitors to perform job duties including reading & writing, as well as when presenting information and communicating with others.
• Frequently required to talk or hear to communicate with employees, candidates, vendors, and others, including presenting information in front of groups.
• Frequently required to reach with arms and hands performing repetitive motions and using finger dexterity to work primarily at a computer keyboard and with a mouse.
• Frequently required to sit, and occasionally required to stand or walk to move around primarily in an office environment.
• Occasionally lift and/or move up to 10 pounds.
• This position may require up to 5% travel with occasional increase in travel demands based on business needs.