SCIENTIST, ANALYTICAL DEVELOPMENT
The Analytical Development Scientist will, under supervision, be responsible for development and execution of analytical test methods that facilitate drug substance and drug product development / manufacturing and regulatory submissions for clinical study introduction through phase 3 trials. Activities includes test method development, qualification/validation, transfer and execution. This position is also called on to support late stage troubleshooting and development of products, processes, and methods in support of product commercialization.
ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to:
- Develop and execute chemical and instrumental methods (e.g. HPLC, GC, TGA, DSC, MS, FTIR) of analyses for development compounds, drug substances, raw materials, intermediates, drug product, and packaging materials.
- Accurately follow established test methods, procedures, and pharmacopeia chapters (e.g. Dissolution) to generate data essential for strategic decision making.
- With supervision, plan and execute in-house stability studies for drug substance’s, intermediates, and prototype drug products.
- With supervision and as appropriate, assist/lead the development of analytical methods, investigations for out of specification, out of trend, and/or anomalous results.
- With supervision, collaboratively plan and execute cross functional studies for chemical development and formulation development.
- Recognize and respond to unexpected or anomalous observations in all activities.
- Maintain complete and accurate records of laboratory work in conformance with company SOPs and training.
- Provide detailed reviews of peer generated data as well as that generated from contracted service providers.
- Maintain the inventory of laboratory consumables and clean glassware.
- Coordinate vendors service calls for repair and maintenance of laboratory instruments, with training perform routine maintenance of laboratory instrumentation, maintain complete and accurate records of instrument service and repairs in conformance with company SOPs and policies.
BS in chemistry or closely related field; minimum 5 years relevant industrial experience in an R&D/QC setting (MS with 3 years)
Proficient using MS-Excel, MS-Word as well as data systems for computer controlled instrumentation.
Significant practical experience conducting HPLC analysis and troubleshooting.
Significant experience evaluating analytical data and drawing meaningful conclusions.
Knowledge of cGMP expectations for laboratory records and quality systems.
Strong attention to detail, excellent written and oral communication skills.
Ability to provide ideas for process improvements.
Ability to work with a team of individuals to meet goals.
Experience working in and accomplishing tasks a timeline driven setting.