Description
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 Production Specialist II Cell Therapy Cell Culture, you will be responsible for clinical manufacturing of novel cell therapy drug substance within the Cell Therapy Module (CT-MOD). You will collaborate closely with Biological Development (BD) and Manufacturing Science and Technology (MSAT) to support new product introductions and ensure platform alignment.
Your Tasks and Responsibilities:
- Operate and execute clinical manufacturing across Solution Preparation, Cell Expansion, Cell Culture, and Final Fill & Freezing, including product changeovers, cleanroom practices, and routine analytics.
- Support new product introductions (NPIs) with BD and MSAT, ensuring activities meet schedule and platform alignment.
- Monitor and control processes using data trending and statistical process control, escalate and support investigations into deviations and product impact.
- Troubleshoot and maintain single-use technology and equipment, coordinate maintenance and repairs with technical teams.
- Author, redline, and review controlled documents, assess documentation impact of material or equipment changes, and support change decisions.
- Perform commissioning, IOPQ/C&Q activities, and execute related documentation under supervision.
- Deliver training as a subject-matter expert, ensure effective shift handovers, and communicate operational status across teams.
- Drive continuous improvement and Lean initiatives, promote safety, and respond flexibly to shift and off-hour coverage needs.
Who You Are: Bayer seeks an incumbent who possesses the following:
Required Qualifications:
- Bachelor's degree in a science-related field with 2+ years of relevant pharmaceutical/biotech manufacturing operations experience, or Master's degree (or equivalent combination of education and experience).
- Practical knowledge of aseptic techniques and cleanroom operations, and experience working within cGMP environments.
- Strong understanding of data integrity, regulatory expectations (FDA, EMA, etc.), and pharmaceutical manufacturing documentation requirements.
- Demonstrated ability to troubleshoot equipment and process issues independently and provide timely technical decisions during campaigns.
- Proficiency with business IT systems and Microsoft Office for data review, documentation, and communication.
- Effective oral and written communication skills, ability to train others, and work collaboratively across shifts and functions.
- Flexibility to support changing schedules and provide off-hour coverage when needed, and ability to lift up to 45 lb.
Preferred Qualifications:
- Direct experience in cell therapy manufacturing, single-use technologies, or working with pluripotent stem cell expansion and differentiation.
- Experience with Lean manufacturing methods and continuous improvement projects.
Salary and Benefits: Employees can expect to be paid a salary between $66,560.00 - $99,840.00. Additional compensation may include a bonus or incentive compensation (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.