R&D Chemist II

Nephron Pharmaceuticals; West Columbia (SC); On-site; USD 120,000 - 150,000; Full time

Job summary

Nephron Pharmaceuticals is seeking an experienced R&D scientist to lead and execute research projects for established and new products. You will apply analytical method development and validation, perform stability studies, and support GMP compliance across regulatory submissions.

Responsibilities include drafting R&D and QC protocols, evaluating raw materials, and coordinating with QA to ensure on-time delivery of development summaries for clients and the FDA. Strong communication is essential.

Qualifications

• Master’s Degree in Chemistry; 8–10 years of experience in a cGMP environment.
• Experience in analytical method development and validation.
• Proven ability to manage multiple R&D projects with timelines.

Responsibilities

• Perform R&D projects including analytical method validation/transfer/verification, deformulation, and investigations.
• Plan, organize, and manage resources on projects to ensure quality and schedule adherence.
• Draft R&D and QC protocols and reports; develop methods for pharmaceutical ingredients.
• Support GMP data generation and ensure compliance with FDA and clients.
• Oversee development summaries documenting product development for clients and authorities.

Skills

LCMS analysis

HPLC/UPLC

GC

Mass Spectrometry

FT-IR

UV/Vis spectroscopy

Wet chemistry

Analytical testing

Project management

Scientific writing

Education

Master’s Degree in Chemistry

Tools

HPLC systems

Mass spectrometers

FT-IR spectrometers

Analytical instrumentation

Job 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
  

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