R&D Chemist II

RXinsider LTD.; Columbia, Northern (SC, KY); Hybrid; USD 110,000 - 140,000; Full time

Job summary

RXinsider LTD. is seeking an experienced pharmaceutical analytics scientist to lead R&D projects across established and new products. You will validate and transfer analytical methods (LCMS/HPLC/UPLC, GC, FT-IR, UV/Vis) and generate GMP data in a fast-paced environment.

The role emphasizes method development, troubleshooting, and collaboration with QA and regulatory teams to ensure compliant documentation and timely submissions.

Qualifications

• Regionally accredited Master’s Degree in Chemistry with 8–10 years of cgmp experience.
• Experience with analytical methods including LCMS, HPLC/UPLC, GC, FT-IR, UV/Vis.
• Experience in method development, validation, transfer, and troubleshooting.
• Ability to draft and review protocols and reports; strong communication.

Responsibilities

• Perform research and development projects for established products and new products including analytical test method validation/transfer/verification, deformulation, procedures, investigations, and other non-specified projects or initiatives.
• Plans, organizes, and manages resources on projects to assure technical quality and schedule adherence.
• Oversee and ensure reports, submission documentation, and development summaries documenting the product development process for clients, partners, and health authorities (FDA).
• Participates in development and implementation of associated programs (e.g. cleaning validation, process validation, GMP compliance, equipment validation).

Skills

LCMS

HPLC

UPLC

GC

FT-IR

UV-Vis

Wet chemistry

Analytical method development

Troubleshooting

Communication skills

MS Office

Education

Master’s Degree in Chemistry

Tools

MS Office

Job description

Description

Job Purpose:

• Perform research and development projects for established products and new products including but not limited to analytical test method validation/transfer/verification, deformulation, procedures, investigations, and other non-specified projects or initiatives.
• Plans, organizes, and manages resources on projects to assure technical quality and schedule adherence.

Performs other duties as assigned or apparent

Essential Duties And Responsibilities

• Capable of working in a GMP environment and responsible for generating GMP data.
• Capable of working with different analytical techniques including but not limited to HPLC, UPLC, GC, Automatic Titrator, IR, DSC, ICP, and Mass Spectrometry.
• Responsible for performing different analytical tests for R&D and QC as needed.
• Responsible for executing research and development projects for established products and new product development with respect to formulation, laboratory investigations, and early process development.
• Responsible for evaluating new raw materials and components for quality and safety prior to implementation into exhibit batches and GMP production.
• Responsible for conducting the development and validation of analytical methods for pharmaceutical ingredients and dosage forms, including establishment of specifications.
• Assist in drafting R&D and QC protocols and report.
• Performs research and development stability testing as necessary.
• Participates in the development and implementation of associated programs (e.g. cleaning validation, process validation, GMP compliance, equipment validation, maintenance and use, etc.).
• Oversee and ensure reports, submission documentation, and development summaries documenting the product development process are available for clients, partners, and health authorities (i.e. FDA).

Supplemental Functions

• Performs job duties with minimal supervision.

Knowledge & Skills

• Highly skilled in conducting analysis by LCMS, HPLC, UPLC, GC, FT-IR, UV/Vis spectroscopy as well as wet chemistry techniques, needing little or no guidance.
• Strong interpersonal, verbal, and written communication skills. Effective organization, multitasking, and problem-solving skills
• Computer experience (Microsoft Word, Excel, Power Point, Project)
• Specific expertise, skills and knowledge within research, product development, analytical method development, and troubleshooting gained through education and/or experience
• The ability and willingness to change direction and focus to meet shifting organizational and business demands
• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals
• Possesses the initiative and follow through to implement, track and achieve on-time completion of projects, as assigned by management.
• Must strive for continuous improvement in all work activities.
• The ability to take strategic objectives and accept accountability, motivate and influence others thinks globally and leverages diversity

Education/Experience

• Regionally accredited Master’s Degree in Chemistry and/or a minimum of 8 - 10 years of previous experience in cGMP related environment

Working Conditions / Physical Requirements

• Position requires typing, climbing, lifting (up to 15lbs), reaching, vision (20/20), standing (10%), sitting (90%), walking, and hearing
• Additional Requirements: As needed