This leading Cell & Gene Therapy Biotech is looking for a scientific analytical development leader who has experience in a fast paced environment while managing a team and performing analytical tests to support the company's innovative cell & gene therapy products.
- Lead a team of analytical associate scientists, providing guidance on analytical testing to support the C> platform
- The role will require the ability to teach analytical techniques for cell and gene therapy products such as flow cytometry, cell-based assays/immunoassays, next generation sequencing, TCID-50, qPCR, ddPCR, HPLC, and capillary electrophoresis.
- Manage an in-house ELN/LIMS function for time sensitive tracking of samples/results and train all users.
- Execute administrative laboratory functions such as ample management, data reporting standards, instrument use and employee resource scheduling, laboratory chemical and critical reagent inventory.
- SOPs, development reports, test records,and protocols etc.
- Assist with CMC regulatory submissions.
- Method transfers from the internal QC department or CTOs.
- Minimum MS with +10 years of experience in analytical development
- Leadership and lab management experience. (Including strong written, verbal, interpersonal, and organizational skills)
- Experience with ELN/LIMS
- Modern analytical techniques such as (HPLC, Capillary Electrophoresis, ELISAs, ect.) is a must
- AAV Gene Therapy/ CAR-T Cell Therapy experience is highly desired