Sr Prod Spec Cell Therapy Cell Culture

At Bayer, we're visionaries driven to solve the world's toughest challenges and strive for a world where 'Health for all, Hunger for none' is a reality.

As a Sr. Product Specialist Cell Therapy Cell Culture, you will be a subject matter expert (SME) responsible for the clinical manufacturing of novel cell therapy drug substance and drug product within the Cell Therapy Module (CTMOD). You will collaborate closely with Biological Development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensure platform alignment.

Responsibilities

The primary responsibilities of this role are:

• Take responsibility for manufacturing activities in assigned areas, including Solution Preparation, Cell Expansion & Differentiation, Cell Suspension for Injection (CSI), Cell Banking, Drug Product Filling and Packaging.
• Manufacture products across various phases of the product life cycle, from clinical through launch, while ensuring adherence to cGMP and internal standards.
• Develop training curricula and training materials for the CTMOD team, deliver SME training, and ensure own training remains fully compliant.
• Adapt shift patterns and working hours to support CSI and surgical requirements, and participate in ad hoc project needs.
• Lead the manufacturing aspects of projects, including new product introductions (NPIs) into CCTC in close collaboration with BD and MSAT tech transfer teams.
• Build new technical and business processes and/or drive optimization of existing processes related to documentation, sample handling, automation, and cGMP.
• Manage, handle, and troubleshoot single-use technology (SUT) end-to-end in the manufacturing process.
• Perform commissioning and IOPQ of equipment, review, approve, and execute C&Q documentation.
• Make appropriate independent decisions with minimal supervision, identify and engage relevant stakeholders for input, raise and support deviation investigations.
• As SME, lead and participate in regulatory and internal audits, including preparing and delivering presentations to auditors.

Requirements

• Bachelor's degree in a relevant life science or engineering discipline (e.g., Biotechnology, Cell Biology, Biochemistry, Biomedical Engineering).
• 5–7 years of relevant experience in cell therapy, biologics, or advanced therapy medicinal product (ATMP) manufacturing.
• Demonstrated expertise in end-to-end cell culture operations.
• Strong understanding of cGMP regulations, quality systems, documentation practices, and compliance expectations.
• Proven experience supporting or leading new product introductions (NPIs) and/or technology transfers into manufacturing.
• Proficiency in using data analysis and statistical process control tools.
• Experience authoring, reviewing, and approving controlled documents.

Benefits

• Salary between $93,840.00 to $140,760.00.
• Additional compensation may include a bonus or commission.
• Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.