Job 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.