Description:
We are looking for an analytical expert that will independently identify, develop use and transfer new analytical methods/ techniques to support the late-stage development of biological pipeline programs. The successful candidate will continuously seek to improve existing laboratory methods and processes while demonstrating expertise of a broad range of experimental techniques and methods of data analysis.
Responsibilities include:
- Independently design, execute and interpret experiments for the development, validation and transfer of analytical methods for biologics including neurotoxins. Analytical technologies include HPLC, ELISA, general physico-chemical and pharmacopeial methods.
- Perform analytical testing to support biologics process and product development.
- Understand the broad objectives of the project as well as their role in achieving those objectives, and modify experimental plan when required, to respond.
- Learn, understand and master new experimental techniques, and act as a resource or mentor for others.
- Demonstrate a high level of proficiency in his/her field.
- Set and meet project timelines.
- Effectively organize and present scientific plans and data.
- Liaise with local and global interfacing functions.
- Contribute to writing and conceptual framework of regulatory submissions.
- Contribute to local and global scientific and transformational initiatives.
- Impact projects mostly through lab and/or pilot plant-based activities where applicable.
Qualifications
- BSc Level 8 or equivalent education with typically 7 or more years of experience or MSc Level 9 or equivalent education with typically 5 or more years of experience.
- Demonstrated ability to independently design, execute and interpret critical experiments for the development, validation and transfer of analytical methods intended for release and stability testing under cGMP.
- Solid knowledge and experience with relevant regulatory and cGMP standards and operational and compliance requirements of Quality Control laboratories.
- Capability to perform basic statistical data analyses. Experience with statistical Design of Experiments (DoE) is a plus.
- Demonstrated ability to learn, understand and master new experimental techniques.
- Ability to multitask and work within timelines.
- Demonstrated scientific writing skills, strong verbal communication skills and ability to work in cross-functional local and global project teams.