Production Specialist III Cell Culture Technology Center

Bayer • Berkeley, CA

410d • $86,568 - $123,852

About The Position

The Production Specialist III at Bayer's Cell Culture Technology Center is responsible for the clinical manufacturing of monoclonal antibodies (mAB) drug substances. This role involves collaboration with biological development and manufacturing science teams to ensure successful new product introductions and alignment with platform processes. The specialist will manage various aspects of manufacturing, including cell culture, purification, and documentation, while driving continuous improvements and ensuring compliance with regulatory standards.

Requirements

• Bachelor's Degree with industry experience or an equivalent combination of education and experience.
• Demonstrates strong independent thinking and decision-making skills.
• Ability to articulate decision-making processes clearly.
• Experience with data integrity, regulatory, and cGMP requirements for pharmaceutical manufacturing.
• Experience with Lean manufacturing principles and business IT systems.
• Excellent computer skills, including proficiency in Microsoft Office.

Nice To Haves

• BS in a science-related field with 4+ years of industry experience, or MS or PhD in a science-related field with no prior industry experience.
• Previous experience in technology transfers or New Product Introduction.
• Experience in upstream processes such as ProA, AEX, CEX, Viral Filtration, and TFF, Delta V, Single use.

Responsibilities

• Responsible for all aspects of clinical manufacturing in areas such as Cell Expansion, Cell Culture, Purification, Solution Preparation, and Weigh/Dispense.
• Participates in new product introductions (NPIs) into CCTC with support from BD and MSAT.
• Ensures all activities are performed to schedule and acts as a delegate to Sr. Production specialist.
• Collaborates with BD and MSAT to ensure cross-functional alignment with platform processes, equipment, raw materials, and automation.
• Manufactures products in various phases of product life cycles from clinical through launch.
• Handles and troubleshoots single-use technology (SUT) in the manufacturing process.
• Monitors and controls processes using data trending and statistical process control.
• Authors, redlines, and reviews controlled documents for various equipment/processes.
• Assesses documentation impact of proposed changes in materials and equipment, providing decision-making recommendations.
• Creates, owns, and drives business processes of moderate complexity in CCTC.
• Raises and supports investigation of deviations and partners cross-functionally to determine product impact and root cause.
• Participates in regulatory and internal audits, leading internal audit walkthroughs.
• Performs commissioning and IOPQ of CCTC equipment and executes C&Q documentation.
• Supports development of training curricula and generates training materials for CCTC team.

Benefits

• Health insurance
• Dental insurance
• Paid time off
• Vision insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree