Director/Assoc Director, Analytical Development

WHO WE ARE:

Theradaptive is revolutionizing the field of therapeutic delivery with a pipeline of best-in-class products that address multiple global markets. Theradaptive is performing cutting edge science in the area of regenerative medicine, working at the interface of Biology and Orthopedic tissue repair.
Our lead therapeutics are in the following indications:

• • Spinal Fusion
  • Long Bone Repair
  • Osteochondral Repair
  • Dental and Facial Bone Repair
  • Immuno-Oncology

We are an innovative, fast-paced team that is advancing a diverse array of cutting-edge translational research projects.

POSITION SUMMARY:

We are seeking a talented Director/Associate Director, Analytical Development. The successful candidate will be responsible for building and leading the Analytical Development team by hiring members at different levels, equipment selection, advancing analytical method development, and qualification and transfer for Theradaptive’s pipeline programs. This individual will oversee a combined Analytical Development and Quality Control team. As a team leader, this individual will be responsible for the implementation of methods, including transfer and bridging, for use in Quality Control testing of GMP and in development testing of PD/R&D samples. This individual will be responsible for developing analytical testing strategies for Biologic Drug Substances and Drug Product/Medical Devices including justifying specifications based on data and statistical analysis, in-process and release assays, and stability testing.

 

This individual will demonstrate a thorough knowledge and understanding of technologies required to implement new analytical methods and define analytical control strategies by applying Quality by Design principles and Design Control strategies.  As the Analytical Development team lead, this individual will also help establish and lead through the initial establishment of Quality Control for qualification, bridging and routine testing activities. The selected individual will have working knowledge and application of US and EU regulatory requirements, regulatory expectations, and compliance.  As part of a dynamic fast paced and growing organization, the successful candidate will have the ability to adapt to the needs of an innovative and collaborative environment.

 

If you are driven to contribute in an exciting and dynamic environment, we encourage you to apply now!