Senior Cell Therapy Manufacturing SME | Cell Culture & GMP

Bayer; Berkeley (CA); Presencial; USD 94.000 - 141.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health care

Vision insurance

Dental

Retirement plan

PTO

Sick leave

Descripción de la vacante

Bayer in Berkeley, CA seeks a Sr. Product Specialist Cell Therapy Cell Culture to lead clinical manufacturing and drive scalable, compliant operations for novel cell therapies. You will partner with BD and MSAT to introduce products and optimize processes.

Requires 5–7 years in cell therapy with mammalian culture, cGMP know‑how, data analysis skills and SMt documentation expertise. Role may involve flexible shifts to meet schedules and patient‑timing needs.

Formación

• Bachelor’s degree in life science or engineering required.
• 5–7 years in cell therapy manufacturing with mammalian culture experience.
• Experience with cGMP, QA, and documentation practices.

Responsabilidades

• Manufacture CTMOD areas including solution prep, cell expansion, differentiation, CSI, banking and packaging as SME.
• Ensure cGMP compliance and product quality from clinical to launch stages.
• Develop training materials and deliver SME training for CTMOD.
• Adapt shifts to support CSI and surgical requirements; engage in project work.
• Lead NPIs and tech transfers with BD/MSAT; coordinate with partners and schedules.
• Lead audits, safety investigations and corrective actions across teams.

Conocimientos

Cell culture operations

cGMP compliance

Data analysis

SUT

Documentation

Educación

Bachelor’s degree in life science or engineering

Advanced degree

Herramientas

MES

LIMS

Electronic batch records

Descripción del empleo

Bayer in Berkeley, CA seeks a Sr. Product Specialist Cell Therapy Cell Culture to lead clinical manufacturing and drive scalable, compliant operations for novel cell therapies. You will partner with BD and MSAT to introduce products and optimize processes.

Requires 5–7 years in cell therapy with mammalian culture, cGMP know‑how, data analysis skills and SMt documentation expertise. Role may involve flexible shifts to meet schedules and patient‑timing needs.