R&D CHEMIST I

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
• Affixes to draft R&D and QC protocols and reports
• 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.