R&D Chemist II

Nephron Pharmaceuticals Corporation; Columbia, Northern (SC, KY); Hybrid; USD 120,000 - 190,000; Full time

Job summary

Nephron Pharmaceuticals Corporation in the United States seeks a senior scientist to lead analytical method development for both established and new products. You will validate tests, transfer methods, and guide projects from concept to execution while ensuring GMP compliance.

Responsibilities include planning resources, generating GMP data, and collaborating with QA, manufacturing, and regulatory teams to support FDA submissions and product development timelines.

Qualifications

• Master’s degree in Chemistry or equivalent with cgMP exposure.
• 8–10 years of experience in a cGMP environment.
• Experience validating/ transferring analytical methods and troubleshooting.

Responsibilities

• Capable of working in a GMP environment and generating GMP data.
• Capable of applying analytical techniques (HPLC, UPLC, GC, FT-IR, UV/Vis) for R&D and QC.
• Execute R&D projects for product development, formulation, and process development.
• Evaluate new raw materials for quality and safety before use in GMP batches.
• Draft and review R&D and QC protocols and reports.
• Oversee reports, development summaries, and documentation for clients/health authorities.

Skills

LCMS

HPLC

UPLC

GC

FT-IR

UV/Vis spectroscopy

Interpersonal & writing

Education

Master’s Degree in Chemistry

Tools

Microsoft Word

Excel

PowerPoint

Project

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