Job description:
The Analytical DevelopmentEarly Stage group within Biologics ARD is responsible for support of programs that are preparing for FIH clinical studies. The team leads Stage 1 method development optimization and validation. In collaboration with crossfunctional partners the team supports early phase formulation and process development studies. Key deliverables include product control strategies informed by analytical data and method understanding; robust analytical methods suitable for commercial QC labs; comprehensive data packages that drive product and process understanding; clinical supplies release testing and stability studies to establish clinical product dating; substantial clinical trial application submission content.
Responsibilities:
- Laboratory operational support for the groups experimental development and testing activities.
- Complex solution preparation in a GxP environment.
- Laboratory balance checks and pH meter standardizations.
- Inventory/resource management (e.g. ordering supplies stockkeeping etc..
- Laboratory hygiene including waste disposal management and safety checks.
- Document experimental data appropriately in an electronic laboratory notebook.
- Problem solving either independently or with assistance pertaining to experiment and/or instrumentation issues.
- Identify areas for improvement in laboratory operations to improve efficiency and resource usage and assist in continuous improvement activities.
- Understand and adhere to client corporate standards regarding code of conduct safety policies and procedures and GxP compliance.
Requirements:
- BS 02 years) in scientific discipline (e.g. Chemistry Biochemistry or Biology) with previous laboratory experience.
- Experience in Microsoft Office (Excel Power Point and Word) required.
- Experience with bioanalytical techniques is preferred.
- Connect with peers internally and crossfunctionally to facilitate communication discuss ideas and nurture innovation.
- Be open and receptive to others ideas and suggestions for personal improvement.
- Learn quickly be adaptable and agile and raise the bar for performance.