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 include isolators, aseptic filling equipment, mixers, pumps, biosafety cabinets, glove integrity testers, environmental monitoring equipment, etc. Cleans and decontaminate equipment. Maintains housekeeping of the workplace. Prepare 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.

The primary responsibilities of this role are:

• 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. Work 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. Participate 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.

Bayer seeks an incumbent who possesses the following:

• 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.
• Experienced with Lean manufacturing principles.
• Experienced 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 year 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 merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

This posting will be available for application until at least: 4/30/2026.

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Health for all, Hunger for none, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.

To all recruitment agencies:
Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/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) using the contact information below.

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