St. Louis, MO
Our client, a rapidly growing pharmaceutical company is looking for an Analytical R&D Chemist. The Analytical R&D Chemist is 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:
- Develop new analytical methods for finish products of various formulations (Assay, Related substances, Dissolution, residual solvents, and others if any).
- Qualify, validate, and transfer analytical methods for API, raw materials, and finish products in QC, with appropriate documentation of these activities.
- Provide analytical support to Formulation Development on various formulations.
- Analysis of various R&D samples at initial and during stability.
- Work with outside vendors to transfer established methods.
- Understand US FDA requirements for generic drug product development, create API, Raw material, and finish product specifications.
- Aware 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 and coordinate with different departments for product filing and to solve problems.
- Maintain control substance inventory as needed basis.
- Procurements of the chemicals, reagents, and standards as needed.
- Provide support to close OOS, investigations as needed.
Skills and Abilities Required:
- Ability to develop in vitro assays to characterize critical quality attributes of potential development products
- Experience with HPLC, GC, spectrometers, AAS, Dissolution apparatus, wet chemistry techniques etc.
- Knowledge and awareness of cGLP, cGMP, and FDA submission.
- Strong verbal and 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, Organic Chemistry, analytical chemistry, or related field with 1 year of laboratory experience.
- Strong chromatography and wet chemistry background preferred.
- Experience in solid oral extended-release formulations is preferred.