Production Specialist II Cell Therapy Cell Culture Berkeley, CA

At Bayer were visionaries driven to solve the worlds toughest challenges and striving for a world where Health for all Hunger for none is no longer a dream but a real possibility. Were doing it with energy curiosity and sheer dedication always learning from unique perspectives of those around us expanding our thinking growing our capabilities and redefining impossible. There are so many reasons to join us. If youre hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference theres only one choice.

Production Specialist II Cell Therapy Cell Culture - Berkeley CA

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 (CTMOD);
You collaborate closely with Biological Development (BD) and Manufacturing Science and Technology (MSAT) to support new product introductions and ensure platform alignment;

YOUR TASKS AND 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 singleuse 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 subjectmatter 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 offhour coverage needs.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Bachelors degree in a sciencerelated field with 2 years of relevant pharmaceutical/biotech manufacturing operations experience or Masters 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 offhour coverage when needed and ability to lift up to 45 lb.

Preferred Qualifications:

• Direct experience in cell therapy manufacturing singleuse technologies or working with pluripotent stem cell expansion and differentiation;
• Experience with Lean manufacturing methods and continuous improvement projects.