Product Specialist II Cell Therapy Drug Product

Product Specialist II Cell Therapy Drug Product

Focuses on setting up, operating, maintaining, and troubleshooting manufacturing production that includes isolators, aseptic filling equipment, mixers, pumps, biosafety cabinets, glove integrity testers, environmental monitoring equipment, etc. Cleans and decontaminates equipment. Maintains housekeeping of the workplace. Prepares media and solutions to support the cell therapy process. Performs visual inspection of drug product vials. Conducts routine analytics and takes samples. Coordinates equipment maintenance and repairs with the technical team.

Documents and communicates work results during shift handovers.

• Responsible for clinical manufacturing novel cell therapy drug substance within the Cell Therapy Module, CT-MOD. Collaborates closely with biological development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensures platform alignment.
• Works with a single‑cell line from expansion, through differentiation and fill/finish process to manufacture a unique product using single‑use technology. Manufactures products in various phases of product life cycles from clinical through launch. Responsible for all aspects of clinical manufacturing in the following areas:
  Solution Preparation, Cell Expansion, Cell Culture, and Final Fill and freezing.
• Ensure all activities are performed to schedule.
• Clearly understands, communicates, and manages differences in terms of documentation, sample handling, automation, cGMPs, etc. for different phases of the product life cycle.
• Authors, redlines, and reviews controlled documents for various equipment/processes.
• Monitors and controls processes using data trending and/or statistical process control. Works cross-functionally to ensure process is controlled and issues are escalated and investigated.
• Raises and supports investigation of deviations.
• Partners cross-functionally to determine product impact and root cause. Implements and executes manufacturing tasks in alignment with effective corrective actions to prevent re-occurrence. Participates in regulatory and internal audits. Supports commissioning and qualification of equipment.
• Participates in safety investigations for CT-MOD and always promotes safe behaviors. Partners cross-functionally to identify and implement corrective actions.

• Experience in pharmaceutical operations, preferably biotech or an equivalent combination of education and experience.
• Strong understanding of FDA, EMA, etc., and cGMP requirements for pharmaceutical manufacturing.
• Experience with Lean manufacturing principles.
• Experience with business IT systems.
• Excellent computer skills; experienced with Microsoft Office Suite of tools (Word, Excel, PowerPoint, Access, etc.).
• Ability to lift 45 lbs.

• Bachelor’s Degree in a science related field.
  
  Minimum Experience:
  
  BS +2 years, or MS +1 years of related experience in pharmaceutical operations, preferably biotech or an equivalent combination of education and experience.
• Computer programming or automation support.

Employees can expect to be paid a salary of between $64,000.00 – $97,000.00. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc. This salary range is an estimate and may vary based on location, market data, applicant’s skills, prior experience, degrees, certifications, and other factors. This posting will be available for application until at least April 30 2026.

Bayer is an Equal Opportunity Employer, including Disabled and Veterans. Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s).

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Location:

United States – California – Berkeley

Division:
Pharmaceuticals

Reference Code: 866645

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