# Production Specialist III Cell Therapy Drug Product **Company**: Bayer **Location**: Berkeley **Work arrangement**: onsite **Experience**: senior **Job type**: full-time **Salary**: $77,760.00 - $116,640.00 **Category**: Manufacturing **Industry**: Healthcare **Wikidata**: https://www.wikidata.org/wiki/Q152051 **Apply**: https://talent.bayer.com/careers/job/562949976957606?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_b02f78a2-939 ## Description At Bayer, we're seeking a Production Specialist III Cell Therapy Drug Product to join our Cell Therapy Module (CT-MOD) team in Berkeley, CA. As a key contributor to our clinical manufacturing operations, you will be responsible for executing end-to-end clinical manufacturing of novel cell therapy drug substance, including solution preparation, cell expansion, cell culture, final fill, and freezing using single-use technology. In this role, you will collaborate closely with Biological Development (BD) and Manufacturing Science and Technology (MSAT) to introduce new products, ensure platform alignment, and support the development and implementation of CT-MOD's business strategy. You will work across multiple phases of the product life cycle, from clinical through launch, acting as a subject matter expert in at least one area while helping to shape robust, compliant, and innovative cell therapy manufacturing operations. Key responsibilities include: Executing end-to-end clinical manufacturing of novel cell therapy drug substance within CT-MOD, including solution preparation, cell expansion, cell culture, final fill, and freezing using single-use technology Handling, operating, and troubleshooting single-use technology (SUT) and associated equipment across the manufacturing process, ensuring reliable and compliant performance Participating in and helping lead new product introductions (NPIs) into CT-MOD in close collaboration with BD and MSAT, ensuring activities are executed on schedule and acting as delegate to the Sr. Production Specialist as needed Collaborating cross-functionally with BD, MSAT, and other partners to align platform processes, equipment, raw materials, and automation, and to manage differences across product life-cycle phases (documentation, sample handling, automation, cGMPs, etc.) Authoring, redlining, and reviewing controlled documents for equipment and processes, assessing the impact of changes in materials and equipment, and providing recommendations to support sound change control and platform alignment Monitoring and controlling manufacturing processes using data trending and/or statistical process control, escalating and supporting investigation of issues and deviations, and implementing effective corrective and preventive actions Performing commissioning and IOPQ of CT-MOD equipment, executing C&Q documentation, and participating in regulatory and internal audits, safety investigations, and related compliance activities while promoting safe behaviors at all times Supporting and helping develop CT-MOD business processes and training curricula, generating training materials, maintaining personal training compliance, and driving continuous improvement by challenging the status quo and proposing innovative solutions We seek an incumbent who possesses a Bachelor's degree in a science-related field, preferably biology, cell/cellular biology, biochemistry, biophysics, computer science, or a related discipline. Aseptic Processing Experience (ISO 5 or better) and cGMP experience are also required. The ideal candidate will have a strong understanding of data integrity, regulatory requirements (e.g., FDA, EMA), and cGMP requirements for pharmaceutical manufacturing. Additional qualifications include excellent computer skills, including proficiency with Microsoft Office (Word, Excel, PowerPoint, Access) and experience with automation systems; familiarity with filling and isolator equipment; ability to work on and communicate complex problems where analysis of situations or data requires evaluation of multiple factors, with effective written and verbal communication, networking, and presentation skills across shifts and functions; proven ability to lead and work in teams, build sustainable cross-functional partnerships, and influence, recommend, and help implement strategies, processes, and procedures; willingness and ability to change shift schedules based on business and process needs, including providing off-hour (night/weekend) coverage on short notice, and ability to lift up to 45 lbs in line with occupational/physical requirements. Preferred qualifications include a Bachelor's degree with 4+ years of relevant experience in pharmaceutical operations, preferably biotech, or a Master's degree with 2+ years of relevant experience; previous experience with technology transfers or new product introductions in a cGMP environment; knowledge of or interest in computer programming to support data, automation, or process-control activities; demonstrated experience acting as a change agent for complex equipment and processes, applying effective change management while maintaining quality and long-term objectives; track record of self-motivation, accountability, and resilience, with a strong drive for results, continuous learning, and development, and a commitment to integrity, transparency, fairness, and respect. ## Skills ### Required - Aseptic Processing Experience - cGMP experience - Data Integrity - Regulatory Requirements - Pharmaceutical Manufacturing - Microsoft Office - Automation Systems - Filling and Isolator Equipment - Complex Problem-Solving - Effective Communication - Team Leadership - Cross-Functional Partnerships - Strategic Implementation ### Nice to have - Bachelor's Degree in Science-Related Field - Biotechnology Experience - Computer Programming - Change Management - Self-Motivation - Accountability - Resilience - Continuous Learning - Development - Integrity - Transparency - Fairness - Respect --- Source: [Apply at talent.bayer.com](https://talent.bayer.com/careers/job/562949976957606?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)