Production Specialist II Cell Therapy Cell Culture - Berkeley, CA

Bayer•Berkeley, CA

16h•$66,560 - $99,840•Onsite

About The Position

As a Prod Spec II Cell Therapy Cell Culture, you are responsible for clinical manufacturing of novel cell therapy drug substance within the Cell Therapy Module (CT‑MOD); You collaborate closely with Biological Development (BD) and Manufacturing Science and Technology (MSAT) to support new product introductions and ensure platform alignment.

Requirements

Bachelor’s degree in a science‑related field with 2+ years of relevant pharmaceutical/biotech manufacturing operations experience, or Master’s degree (or equivalent combination of education and experience)
Practical knowledge of aseptic techniques and cleanroom operations, and experience working within cGMP environments
Strong understanding of data integrity, regulatory expectations (FDA, EMA, etc.), and pharmaceutical manufacturing documentation requirements
Demonstrated ability to troubleshoot equipment and process issues independently and provide timely technical decisions during campaigns
Proficiency with business IT systems and Microsoft Office for data review, documentation and communication
Effective oral and written communication skills, ability to train others and work collaboratively across shifts and functions
Flexibility to support changing schedules and provide off‑hour coverage when needed, and ability to lift up to 45 lb

Nice To Haves

Direct experience in cell therapy manufacturing, single‑use technologies, or working with pluripotent stem cell expansion and differentiation
Experience with Lean manufacturing methods and continuous improvement projects

Responsibilities

Operate and execute clinical manufacturing across Solution Preparation, Cell Expansion, Cell Culture, and Final Fill & freezing, including product changeovers, cleanroom practices and routine analytics
Support new product introductions (NPIs) with BD and MSAT, ensuring activities meet schedule and platform alignment
Monitor and control processes using data trending and statistical process control, escalate and support investigations into deviations and product impact
Troubleshoot and maintain single‑use technology and equipment, coordinate maintenance and repairs with technical teams
Author, redline and review controlled documents, assess documentation impact of material or equipment changes and support change decisions
Perform commissioning, IOPQ/C&Q activities and execute related documentation under supervision
Deliver training as a subject‑matter expert, ensure effective shift handovers, and communicate operational status across teams
Drive continuous improvement and Lean initiatives, promote safety and respond flexibly to shift and off‑hour coverage needs