AD/Director of Process Development (Cell Therapy)

AD/Director of Process Development (Cell Therapy)

Los Angeles, CA (West Hills/Canoga Park)

Direct Hire140-160k + benefits

Talentry is looking for an Associate Director or Director of Process Development for a Biotech company in the West Valley area of Los Angeles in the Cell Therapy field.

The right person will help optimize manufacturing process: including instruments, process flow, documentation, validation, characterization, testing methodology, etc. They will approve reports, protocols, SOPs, and batch records. They will also assist with CAPAs, deviations, and NCRs.

This professional will lead and train people, as well as be a technical hands-on leader to ensure CMC objectives, GMP and FDA requirements, and company policies are met.

Requirements

MS or PHD in Life Sciences, Chemistry, Chemical Engineering, Bioengineering, etc

8+ total years of experience (depending on degree).

5+ years of supervisory/management experience.

Experience authoring CMC sections of submissions, writing SOPs and reports, and documenting processes.

Demonstrated understanding of statistical analysis (including statistical tool usage Minitab, R, etc.)

Excellent communication skills.

Benefits