<p>Description</p> <p>Job Purpose:</p> <p>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.</p> <p>Essential Duties and Responsibilities:</p> <ul> <li>Plans, organizes, and manages resources on projects to assure technical quality and schedule adherence </li><li>Capable of working in a GMP environment and responsible for generating GMP data. </li><li>Capable of working with different analytical techniques including but not limited to HPLC, UPLC, GC, Automatic Titrator, IR, DSC, ICP, and Mass Spectrometry. </li><li>Responsible for performing different analytical tests for R&D and QC as needed. </li><li>Responsible for executing research and development projects for established products and new product development with respect to formulation, laboratory investigations, and early process development. </li><li>Responsible for evaluating new raw materials and components for quality and safety prior to implementation into exhibit batches and GMP production. </li><li>Responsible for conducting the development and validation of analytical methods for pharmaceutical ingredients and dosage forms, including establishment of specifications. </li><li>Assist in drafting R&D and QC protocols and report. </li><li>Performs research and development stability testing as necessary. </li><li>Participates in the development and implementation of associated programs (e.g. cleaning validation, process validation, GMP compliance, equipment validation, maintenance and use, etc.) </li><li>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) </li></ul> <p>Supplemental Functions:</p> <ul> <li>Performs other similar duties as required. </li></ul> <p>Job Specifications and Qualifications:</p> <p>Knowledge & Skills:</p> <ul> <li>Strong interpersonal, verbal, and written communication skills. Effective organization, multi-tasking, and problem-solving skills </li><li>Computer experience (Microsoft Word, Excel, Power Point, Project) </li><li>Specific expertise, skills and knowledge within research, product development, gained through education and/or experience </li><li>The ability and willingness to change direction and focus to meet shifting organizational and business demands </li><li>The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals </li><li>Possesses the initiative and follow through to implement, track and achieve on-time completion of projects, as assigned by management. </li><li>Must strive for continuous improvement in all work activities. </li><li>The ability to take strategic objectives and accept accountability, motivate and influence others thinks globally and leverages diversity </li></ul> <p>Education/Experience:</p> <ul> <li>Regionally accredited Master's Degree in Chemistry and/or a minimum of 8 - 10 years of previous experience in cGMP related environment </li><li>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 </li></ul> <p>Working Conditions / Physical Requirements:</p> <ul> <li>Position requires typing, climbing, lifting, reaching, standing, sitting, walking, and hearing. </li></ul>