R&D Chemist II

RXinsider LTD.; Columbia, Northern (SC, KY); Hybrid; USD 110,000 - 150,000; Full time

Job summary

RXinsider LTD. seeks a senior chemist to drive analytical method development and validation in a GMP environment. You will plan, organize, and manage resources for R&D projects, ensuring quality and schedules while performing HPLC, GC, LC-MS, and related tests.

The role calls for a Master’s in Chemistry and 8–10 years of cGMP experience, with emphasis on method development, troubleshooting, and regulatory documentation. On-site work in Columbia, SC is expected.

Qualifications

• Must have a regionally accredited Master’s in Chemistry and 8–10 years in a cGMP environment.
• Experience in analytical method development and validation.

Responsibilities

• Plan, organize, and manage resources on R&D projects to ensure quality and schedule.
• Perform analytical tests (HPLC, UPLC, GC, LC-MS, FT-IR, UV/Vis) per GMP standards.
• Develop and validate analytical methods for pharmaceutical ingredients and dosage forms.
• Draft R&D and QC protocols and reports; maintain development summaries for clients and health authorities.

Skills

HPLC

LC-MS

GC

Method development

GMP compliance

Data analysis

Cross-functional

Education

Master’s in Chemistry

Tools

Microsoft Office

Project

Job description

Description

• 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