Analytical Scientist - iPSC Based Therapies

Evotec

Goettingen, Germany

We are seeking a dynamic and collaborative Analytical Scientist to play a pivotal role in advancing our state-of-the-art iPSC-based cell therapy products. The ideal candidate will be responsible for establishing and refining a diverse range of analytical methods. In this role, the selected candidate will be a key contributor to process development, process characterization, and product characterization. A deep understanding of method suitability for Quality Control implementation is essential for success in this position. The responsibilities include collaborating within a cross-functional team to ensure that the developed analytical methods can be seamlessly transitioned to GMP manufacturing and meet the highest quality standards.

Your key responsibilities:

Independently design and develop complex molecular and cellular assays for characterization, in-process control (IPC), and release testing for cell therapy products
Lead method qualification and optimization activities to ensure accuracy and reliability
Independently and collaboratively design, execute, and troubleshoot experiments and proficiently analyze and present data
Maintain meticulous records and author/review technical and regulatory documents for completeness, accuracy, consistency, and clarity
Provide technical leadership and mentorship to less experienced team members.
Drive method transfer and implementation into the Quality Control process
Collaboratively drive projects to meet established timelines while upholding the highest quality and data integrity standards
Assist in tech transfer activities and serve as a subject matter expert for matters relating to analytical methods
Continually identify areas for improvement in project work and methods
Contribute to the execution of development studies and routine laboratory operations and maintenance tasks

Your ideal qualifications:

University degree in the biosciences, with several years of experience for candidates with a PhD, or at least 5 years of experience for candidates with a Master's degree, in analytical development within the pharmaceutical or biotechnology sector, particularly in the field of cell therapy
Preferred familiarity with Good Manufacturing Practices (GMP) for biological products or Advanced Therapy Medicinal Products (ATMPs) or experience working in a regulated environment, e.g. GLP is a plus
Strong expertise in several of the following methods: flow cytometry, dPCR/qPCR, ELISA, cell-based cytotoxicity/proliferation assays, and NGS. Expertise in method qualification/validation in a GMP environment would be highly desirable
Experience in applying quality by design principles and Design of Experiments (DOE) approaches for analytical method development
Working knowledge of statistical software tools, such as JMP or MODDE, is advantageous.
Demonstrated ability to work independently to accomplish tasks
High degree of initiative and flexibility, with the ability to work under challenging timelines
Excellent communication skills with ability to interact professionally with all levels of staff, collaborators, and customers
Fluency in written and spoken business English is necessary

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job