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Production Specialist III Cell Therapy Drug Product, Berkeley, CA

Bayer -
Berkeley, CA

Apply Now

Job Details

$77,760 - $116,640 a year

Benefits

Health insurance
Dental insurance
Paid time off
Vision insurance

Qualifications

Data integrity assurance
Engineering equipment malfunctions diagnostics
Microsoft Excel
Automation
Pharmaceutical regulatory compliance
GMP
Industrial equipment troubleshooting
Bachelor's degree
Automated systems
Leading team collaboration initiatives
Data-driven problem-solving
Productivity software
Sterile products production
Delegation
Cross-functional communication
FDA regulations

Full Job Description

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.

Production Specialist III Cell Therapy Drug Product, Berkeley, CA

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.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Production Specialist III Cell Therapy Drug Product, are to:

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.

WHO YOU ARE
Bayer seeks an incumbent who possesses the following:

Required Qualifications:

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.

Preferred Qualifications:

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.

Employees can expect to be paid a salary between $77,760.00 to $116,640.00. 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 5/9/26.

#LI-US
#LI-AMS

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:

867228

Contact Us

Email:

[email protected]

Apply Now

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