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