Product Specialist II Cell Therapy Drug Product

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

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 communicate work results during shift handovers.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Product Specialist II Cell Therapy Drug Product, 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.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• 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 (Work, Excel, PowerPoint, Access, etc.

• Ability to lift 45 lbs.

Preferred Qualifications:

• 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 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.

YOUR APPLICATION

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.

Equal Opportunity Employer Statement: Notice for U.S. Visitors: All information on this site is subject to compliance with local rule and regulations as they may vary from time to time and across different geographies, including, without limitation, U.S. Executive Orders.

Bayer is an E-Verify Employer.

Location: United States : California : Berkeley

Division: Pharmaceuticals

Reference Code: 866645

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