A leading biotech that has a mission to develop novel oncology therapies is seeking a scientific leader to head up their Upstream Process Development Team. Apart from their own platform they are partner with multiple top ten pharma companies.
- Able to facilitate, analyze and interpret the data from experiment results
- Ensure protocols follow company policies, such as cGMP, USP and FDA regulations
- Author, review and strategically impact CMC sections (IND and NDA submissions)
- Experience in process development, cell culture development, scaleup activities, extensive hands on with bioreactor experience.
- Will work and manage in-house and sharing in weekend sampling.
- Lead and overlook biologics programs.
- Management and development of junior staff
- Masters with 10+ years of industry experience.
- Ph.D with 3+ years of industry experience.
- Experience in mammalian cell culture.
- Experience with bioreactor harvest filtration principals.
- Experience with cGMP manufacturing and associated regulations.
- Expertise in bioengineering concepts (PID control, kLa, scaleup/scaledown)