Analytical R&D Chemist Fenton, Missouri
Job Ref: 36427
Analytical Research and Development Chemist
Department: Analytical R&D
FLSA Status: Salaried
Function: Responsible for developing analytical methods to study the physical or chemical properties of drug substances and formulations, with a view to determining the quality and stability of drug products. A strong familiarity with FDA and ICH regulations is required.
Primary Responsibilities and Essential Functions of the Position:
- Analysis of R&D and its stability study sample.
- Provide analytical support to Formulation Development.
- Develop a new analytical methods for finish products (Assay, Related substances, Dissolution).
- Qualify, validate methods and transfer methods to QC as needed.
- Work with outside vendors to transfer established methods.
- Understand US FDA requirements for generic drug product development and awareness of cGMP practices, ICH guidelines to manufacture quality products.
- Work independently with minimum supervision and as a member of a multidisciplinary, international and culturally diverse research team.
- Interact with colleagues with in department and with other departments to solve problems.
- Sample organization as per internal procedure and per DEA requirements.
Skills and Abilities Required:
- Experience with HPLC, Dissolution, GC, spectrometers, AAS etc.
- Ability to develop assay, dissolution and impurity method to characterize critical quality attributes of potential development products.
- Knowledge and awareness of cGLP, cGMP, and FDA submission.
- Strong protocol, report writing skills
- Experience developing analytical methods for pharmaceutical drug products.
- Pharmaceutical analytical development/R&D experience.
Minimum Education and Experience Required:
- BA, BS or MS in Pharmaceutical Sciences, Physical Chemistry, and Organic Chemistry, or related field with 1 year of laboratory experience.
- Strong chromatography background preferred.
- While performing the duties of this job, the employee is regularly required to, stand, sit; use hands and fingers to operate a computer and telephone keyboard reach. Light to moderate lifting.