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Production Specialist III CT-Mod Cell Therapy - Berkeley, CA 

Production Specialist III CT-Mod Cell Therapy – Berkeley, CA

PURPOSE

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 ensure platform alignment.

YOUR TASKS AND RESPONSIBILITIES

• Responsible for performing clinical manufacturing in the following areas: Solution Preparation, Cell Expansion, Cell Culture, and Final Fill and freezing. Employee will work seamlessly across all areas and be able to execute operations for all areas;
• Participate in new products introductions (NPIs) into CT-MOD with support from BD and MSAT. Ensures all activities are performed to schedule. Acts as delegate to Sr. Production specialist;
• Collaborate with BD and MSAT to ensure cross functional alignment with platform process, equipment, raw materials and/or automation for NLT one area;
• Manufacture products in various phases of product life cycles from clinical thru launch. · Clearly understands, and communicates, differences in terms of documentation, sample handling, automation and cGMPs etc. for different phases of product life cycle;
• Handle and troubleshoot single use technology (SUT);
• 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;
• Authors, redlines and reviews controlled documents for various equipment/processes. Ensures alignment with platform philosophy for cell therapy. Assesses documentation impact of proposed changes in materials, equipment and provides decision making recommendations for changes;
• Effectively employ all methods of communication (oral, written, presentation) to ensure knowledge and information transfer across shifts, to management, and cross functionally;
• Create, own, and drives business processes of moderate complexity in CT-MOD. Own and drives to ensure operational readiness and manufacturing of products efficiently;
• Raise and support investigation of deviations. Partner cross functionally to determine product impact and root cause. Implement and execute manufacturing tasks in alignment with effective corrective actions to prevent re-occurrence;
• Participate in regulatory and internal audits;
• Perform commissioning and IOPQ of CT-MOD equipment and executes C&Q documentation under supervision;
• Participate in safety investigations for CT-MOD and promote safe behaviors at all times. Partner cross functionally to identify and implement corrective actions;
• Support development of training curricula and generate training materials for CT-MOD team. Deliver training as SME. Ensure own training is always in compliance;
• Actively look for opportunities to improve, proposes solutions, and encourages same of others. Drive continuous improvements. Challenge the status quo and embrace change.

WHO YOU ARE

Bayer Seeks an incumbent who possesses the following:

REQUIRED QUALIFICATIONS

• Demonstrates strong tendency towards independent thinking and decision making. Able to make logical decisions independently for multiple process work streams with limited information or supervision available. Clearly articulates decision making process;
• Works with highest level of flexibility. Responds easily to last minute changes to production schedule;
• Must be able to change shift schedule based on business and process needs;
• Must provide off-hour (night and weekend) coverage to meet business requirements on short notice;
• Understands functionality of multiple types of equipment such that can troubleshoot and resolve equipment and process related issues independently;
• Self-motivated. Drives own development, sets goals, teaches and encourages others. Provides formal and informal feedback;
• Experienced with data integrity, regulatory, and cGMP requirements for pharmaceutical manufacturing;
• Previous experience in technology transfers or New Product Introduction is beneficial;
• Experienced with Lean manufacturing principles;
• Experienced with business IT systems;
• Experienced with Microsoft Office. Excellent computer skills;
• Acts as a change agent of equipment with moderate complexity and processes. Applies effective change management;
• Ability to lift 45 lb.

Employees can expect to be paid a salary between $77,760.00 to $116,640.00.  Additional compensation may include a bonus or incentive compensation (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 2-2-26.