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

Bayer•Berkeley, CA

43d•Onsite

About The Position

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 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.

Requirements

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
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

Nice To Haves

Previous experience in technology transfers or New Product Introduction is beneficial
Experienced with Lean manufacturing principles

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