Scientist, Analytical Development

Role Summary

Analytical Development Scientist responsible for analytical development using new and existing methodologies for small molecule pharmaceuticals. Performs analytical laboratory activities to support manufacturing of drug products for clinical studies (all phases). Develops, establishes, and validates testing methodologies to control final drug products and supports formulation development. Works in a cGMP environment with emphasis on safety and regulatory compliance.

Responsibilities

• Develops and executes instrumental methods (e.g., HPLC, dissolution) to support manufacturing of drug products intended for use in clinical studies
• Responsible for conducting in-house analytical development laboratory activities to support drug product knowledge and understanding (forced degradation, ASAP, developmental stability, etc.)
• Accurately follows established test methods, procedures, regulatory guidance (e.g., ICH), and pharmacopeia chapters (e.g., Dissolution) to generate data essential for strategic decision making
• With supervision and independently, plans and executes laboratory testing of in-house analytical method development activities, analytical method validation, stability studies for drug products, and formulation development support
• With supervision and independently, assists/leads the development of analytical methods, investigations for out of specification, out of trend, and/or anomalous results
• With supervision, collaboratively plans and executes cross functional studies for chemical development and formulation development
• Recognizes fundamental anomalies in data points, inconsistent results, and identifies issues in experiments / processes
• Able to interpret experimental outcomes and communicate results to broader team
• Create and review technical reports and oral presentations of various analytical activities (e.g., method development reports, investigations, results summary, etc.)
• Maintains complete and accurate records of laboratory work in conformance with company standard operating procedures (SOPs), GxP expectations, and training
• Provides detailed reviews of peer generated data as well as that generated from contracted service providers
• Performs other duties as assigned

Qualifications

• BS/BA degree in chemistry or closely related field and 2+ years of pharmaceutical industry experience in an R&D/QC setting, including conducting HPLC analysis and troubleshooting, evaluating analytical data and drawing meaningful conclusions
• MS/MA degree in chemistry or closely related field preferred and some similar industry experience noted above
• PhD in chemistry or closely related field and some industry experience a plus
• Effective report writing and oral presentations skills are required
• Excellent written and verbal communication skills are required
• Must be able to build excellent working relationships and maintain confidentiality regarding intellectual property and proprietary endeavors of the company
• Demonstration of cross-functional understanding related to drug development
• Practical working knowledge of conducting HPLC analysis and troubleshooting
• Capable of evaluating analytical data and drawing meaningful conclusions
• Knowledge of cGMP expectations for laboratory records and quality systems
• Ability to provide ideas for process improvements
• Begins to understand how to think outside of the technical process and consider the impact decisions will have on the broader scientific goals
• Good knowledge of scientific principles, methods and techniques
• Good knowledge and demonstrated ability working with a variety of laboratory equipment/tools, including: HPLC, dissolution apparatus per USP, Karl Fischer
• Ability to work as part of a team of individuals to meet goals, tasks in a timeline driven setting
• Strong computer skills
• Strong communication, problem-solving, and analytical thinking skills
• Detail oriented yet can see broader picture of scientific impact on team
• Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
• Strong project management skills

Skills

• Analytical thinking and problem-solving
• Proficiency with HPLC, dissolution testing, and related analytical instrumentation
• GxP awareness and cGMP compliance
• Data interpretation and technical reporting
• Cross-functional collaboration and communication
• Strong computer skills
• Attention to detail and scientific judgment

Education

• BS/BA in chemistry or closely related field; 2+ years of pharmaceutical industry experience in R&D/QC
• MS/MA in chemistry or closely related field preferred
• PhD in chemistry or closely related field considered an asset