R&D CHEMIST I

Description Job Purpose:

This role is to Perform research and development projects for established products and new products including but not limited to analytical test method validation/transfer/verification, reformulation, procedures, investigations, and other non-specified projects or initiatives.

Essential Duties and Responsibilities:

Plans, organizes, and manages resources on projects to assure technical quality and schedule adherence 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 other similar duties as required.

Job Specifications and Qualifications:

Knowledge & Skills:

• Strong interpersonal, verbal, and written communication skills. Effective organization, multi-tasking, and problem-solving skills
• Computer experience (Microsoft Word, Excel, Power Point, Project)
• Specific expertise, skills and knowledge within research, product development, 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 Highly skilled in conducting analysis by HPLC, UPLC, GC, FT-IR, UV/Vis spectroscopy as well as wet chemistry techniques, needing little or no guidance Working Conditions /

Physical Requirements:

• Position requires typing, climbing, lifting, reaching, standing, sitting, walking, and hearing.