R&D Chemist II

NEPHRON SC, LLC•West Columbia, SC

1d•Onsite

About The Position

This role involves performing research and development projects for both established and new products. Key responsibilities include analytical test method validation, transfer, and verification, deformulation, procedure development, investigations, and other related initiatives. The position requires planning, organizing, and managing project resources to ensure technical quality and adherence to schedules. The chemist will also be responsible for generating GMP data in a GMP environment and executing various analytical tests for R&D and QC. This includes research and development for new product development, formulation, laboratory investigations, and early process development. Evaluating new raw materials and components for quality and safety, developing and validating analytical methods for pharmaceutical ingredients and dosage forms, and drafting R&D and QC protocols and reports are also crucial aspects of this role. Additionally, the position involves conducting research and development stability testing, participating in the development and implementation of associated programs like cleaning and process validation, and overseeing documentation for product development processes for clients and health authorities.

Requirements

Regionally accredited Master’s Degree in Chemistry
A minimum of 8 - 10 years of previous experience in cGMP related environment
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.
Typing
Climbing
Lifting (up to 15lbs)
Reaching
Vision (20/20)
Standing (10%)
Sitting (90%)
Walking
Hearing

Responsibilities

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.
Plan, organize, and manage resources on projects to assure technical quality and schedule adherence.
Generate GMP data in a GMP environment.
Work with different analytical techniques including but not limited to HPLC, UPLC, GC, Automatic Titrator, IR, DSC, ICP, and Mass Spectrometry.
Perform different analytical tests for R&D and QC as needed.
Execute research and development projects for established products and new product development with respect to formulation, laboratory investigations, and early process development.
Evaluate new raw materials and components for quality and safety prior to implementation into exhibit batches and GMP production.
Conduct 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 reports.
Perform research and development stability testing as necessary.
Participate 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).