Sr Prod Spec Cell Therapy Cell Culture - Berkeley, CA

Bayer•Berkeley, CA

7d•Onsite

About The Position

As a Sr. Product Specialist Cell Therapy Cell Culture, you are 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 collaborate closely with Biological Development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensure platform alignment; In this role, you act as the technical SME for key aspects of the manufacturing process and help shape robust, scalable, and compliant operations that bring innovative cell therapies to patients;

Requirements

Bachelor’s degree in a relevant life science or engineering discipline (e.g., Biotechnology, Cell Biology, Biochemistry, Biomedical Engineering or related field);
5–7 years of relevant experience in cell therapy, biologics, or advanced therapy medicinal product (ATMP) manufacturing, including hands‑on experience with mammalian cell culture and aseptic processing in a cGMP environment;
Demonstrated expertise in end‑to-end cell culture operations such as solution preparation, cell expansion and differentiation, cell banking, and drug product filling and packaging, including experience with single‑use technologies (SUT);
Strong understanding of cGMP regulations, quality systems, documentation practices, and compliance expectations for clinical and launch‑stage products;
Proven experience supporting or leading new product introductions (NPIs) and/or technology transfers into manufacturing, working closely with development and MSAT or equivalent functions;
Proficiency in using data analysis and, where applicable, statistical process control tools to monitor, troubleshoot and optimize manufacturing processes;
Experience authoring, reviewing and approving controlled documents (e.g., SOPs, batch records, work instructions) and supporting equipment commissioning and qualification activities.

Nice To Haves

Advanced degree (e.g., Master’s or PhD) in a relevant scientific or engineering discipline;
More than 7 years of experience in clinical or commercial cell therapy manufacturing, including exposure to late‑stage and launch activities;
Experience designing and delivering technical training curricula and acting as SME trainer for manufacturing teams;
Demonstrated ability to lead cross‑functional initiatives, influence stakeholders outside of manufacturing, and represent manufacturing in audits, investigations and project forums;
Strong communication, collaboration and coaching skills, with the ability to work effectively in a fast‑paced, highly regulated, and multidisciplinary environment;
Experience with automation, electronic systems (e.g., MES, LIMS, electronic batch records) and continuous improvement methodologies to drive process robustness and efficiency;
Willingness and ability to work flexible hours, including modified shifts and occasional off‑hours or weekend work, to support time‑critical manufacturing and surgical schedules.

Responsibilities

Take responsibility for manufacturing activities in assigned areas, including but not limited to Solution Preparation, Cell Expansion & Differentiation, Cell Suspension for Injection (CSI), Cell Banking, Drug Product Filling and Packaging, and work seamlessly across areas as SME for multiple operations;
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 at all times;
Adapt shift patterns and working hours, sometimes at short notice, to support CSI and surgical requirements, and participate in ad hoc project needs such as continuous improvement and site priorities, including extended dedication to high‑priority projects when required;
Lead the manufacturing aspects of projects, including new product introductions (NPIs) into CCTC in close collaboration with BD and MSAT tech transfer teams, ensuring activities are tracked, coordinated with internal and external partners, and delivered to schedule;
Build new technical and business processes and/or drive optimization of existing processes related to documentation, sample handling, automation and cGMP, and train and coach the team on new or optimized processes, equipment and procedures;
Manage, handle and troubleshoot single‑use technology (SUT) end‑to-end in the manufacturing process, author, review and approve controlled documents, ensure alignment with platform philosophy, and assess documentation impact of proposed changes in materials and equipment to provide sound recommendations;
Perform commissioning and IOPQ of equipment, review, approve and execute C&Q documentation, and monitor and control aspects of manufacturing processes using data trending and/or statistical process control, escalating and investigating issues in a cross‑functional setting;
Make appropriate independent decisions with minimal supervision, identify and engage relevant stakeholders for input, raise and support deviation investigations, partner cross‑functionally to determine product impact and root cause, and own and implement effective corrective and preventive actions;
As SME, lead and participate in regulatory and internal audits, including preparing and delivering presentations to auditors, lead safety investigations for CTMOD, consistently promote safe behaviors, and partner cross‑functionally to identify and implement safety‑related corrective actions.