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
