Product Specialist II Cell Therapy Drug Product · Bayer

Fri, 24 Apr 2026 14:10:21 GMT
Manufacturing

Bayer · Berkeley · $64,000.00 – $97,000.00 · onsite

At Bayer, we're seeking a Product Specialist II Cell Therapy Drug Product to join our team. As a key member of our production and manufacturing department, you will be responsible for setting up, operating, maintaining, and troubleshooting manufacturing production that includes isolators, aseptic filling equipment, mixers, pumps, biosafety cabinets, glove integrity testers, environmental monitoring equipment, etc.

Your primary responsibilities will include:

Responsible for clinical manufacturing novel cell therapy drug substance within the Cell Therapy Module, CT-MOD.

Collaborates closely with biological development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensures platform alignment.

Works with a single-cell line from expansion, through differentiation and fill/finish process to manufacture a unique product using single-use technology.

Manufactures products in various phases of product life cycles from clinical through launch.

Responsible for all aspects of clinical manufacturing in the following areas: Solution Preparation, Cell Expansion, Cell Culture, and Final Fill and freezing.

In addition, you will:

Ensure all activities are performed to schedule.

Clearly understand, communicate, and manage differences in terms of documentation, sample handling, automation, cGMPs, etc. for different phases of the product life cycle.

Author, redline, and review-controlled documents for various equipment/processes.

Monitor and control processes using data trending and/or statistical process control.

Work cross-functionally to ensure process is controlled and issues are escalated and investigated.

Raise and support investigation of deviations.

Partner cross-functionally to determine product impact and root cause.

Implement and execute manufacturing tasks in alignment with effective corrective actions to prevent re-occurrence.

Participate in regulatory and internal audits.

Support commissioning and qualification of equipment.

Participate in safety investigations for CT-MOD and always promote safe behaviors.

Partner cross-functionally to identify and implement corrective actions.

If you have experience in pharmaceutical operations, preferably biotech or an equivalent combination of education and experience, and possess a strong understanding of FDA, EMA, etc., and cGMP requirements for pharmaceutical manufacturing, we encourage you to apply for this exciting opportunity.

We offer a competitive salary range of $64,000.00 – $97,000.00, additional compensation may include a bonus or commission (if relevant), and a comprehensive benefits package, including health care, vision, dental, retirement, PTO, sick leave, etc.