Production Specialist III Cell Therapy Drug Product, Berkeley, CA

Bayer•Berkeley, CA

7d•$77,760 - $116,640•Onsite

About The Position

As a Production Specialist III Cell Therapy Drug Product, you are a key contributor within the Cell Therapy Module (CT‑MOD), responsible for clinical manufacturing of novel cell therapy drug substance from cell expansion through differentiation, fill/finish, and freezing using single‑use technologies. You 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. In this role, you 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.

Requirements

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.
Strong understanding of data integrity, regulatory requirements (e.g., FDA, EMA), and cGMP requirements for pharmaceutical manufacturing.
Ability to understand equipment functionality and independently troubleshoot and resolve equipment and process‑related issues.
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.

Nice To Haves

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.

Responsibilities

Execute 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.
Handle, operate, and troubleshoot single‑use technology (SUT) and associated equipment across the manufacturing process, ensuring reliable and compliant performance.
Participate in and help 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.
Collaborate 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.).
Author, redline, and review controlled documents for equipment and processes, assess the impact of changes in materials and equipment, and provide recommendations to support sound change control and platform alignment.
Monitor and control manufacturing processes using data trending and/or statistical process control, escalate and support investigation of issues and deviations, and implement effective corrective and preventive actions.
Perform commissioning and IOPQ of CT‑MOD equipment, execute C&Q documentation, and participate in regulatory and internal audits, safety investigations, and related compliance activities while promoting safe behaviors at all times.
Support and help develop CT‑MOD business processes and training curricula, generate training materials, maintain personal training compliance, and drive continuous improvement by challenging the status quo and proposing innovative solutions.