Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Senior Production Specialist Cell Culture Technology Center
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Senior Production Specialist Cell Culture Technology Center, are to:
- Responsible for all aspects of clinical manufacturing in the following areas: Cell Expansion, Cell Culture, Purification, Solution Preparation and Weigh/Dispense. Employee will work seamlessly across all areas and will be an Subjet Matter Expert (SME) for multiple areas.
- Leads new product introductions (NPIs) into CCTC with support from biological development (BD) and tech transfer teams (MSAT). Ensures all activities are tracked and performed to schedule.
- Actively collaborates with BD and MSAT to ensure cross functional alignment with platform process, equipment, raw materials and/or automation.
- Manufactures products in various phases of product life cycles from clinical thru launch.
- Clearly understands, communicates, and manages complexity in terms of documentation, sample handling, automation and cGMPs etc. for different phases of product life cycle.
- Manages, handles and troubleshoots single use technology (SUT) from end to end in manufacturing process.
- Monitors and controls all aspects of manufacturing processes using data trending and /or statistical process control. Works cross functionally to ensure process is controlled and issues are escalated and investigated.
- Authors, reviews and approves controlled documents. Ensures alignment with platform philosophy for CCTC. Assesses documentation impact of proposed changes in materials, equipment and provides decision making recommendations forchanges.
- Effectively employs all methods of communication (oral, written, presentation) to ensure knowledge and information transfer across shifts, to management, and cross functionally.
- Creates, owns, and drives complex business processes for CCTC to ensure operational readiness and manufacturing of products efficiently.
- Raises and supports investigation of deviations. Partners cross functionally to determine product impact and root cause. Owns and Implements effective corrective actions to prevent re-occurrence.
- As SME, leads and participates in regulatory or internal audits including presentations to auditors.
- Performs commissioning and IOPQ of CCTC equipment. Review, approve, and execute C&Q documentation.
- Leads safety investigations for CCTC and promotes safe behaviors at all times. Partners cross functionally to identify and implement corrective actions.
- Develops training curricula and training materials for CCTC team. Delivers training as SME. Ensures own training is always in compliance.
- Actively tracks and looks for opportunities to improve, proposes solutions, and encourages same of others. Drives continuous improvement opportunities through to fruition. Challenges the status quo and embraces change.
WHO YOU ARE
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- Bachelor's Degree with 6+ Years of industry experience, or Master's Degree with 2+ Years of industry experience, or PhD with no prior industry experience
- Demonstrates strong tendency towards independent thinking and decision making. Makes logical decisions under pressure and 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 all equipment functionality 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. Excellent understanding of data integrity, regulatory, and cGMP requirements for pharmaceutical manufacturing
- Previous experience in technology transfers or New Product Introduction is beneficial
- Excellent understanding of Lean manufacturing principals
- Experienced with business IT systems
- Experienced with Microsoft Office. Excellent computer skills.
- Acts as a change agent of complex equipment and processes. Applies effective change management.
- Acts as delegate to CCTC Production manager if needed.
Ability to lift 45 lb.
Reference Code: 49560
Functional Area: Production&Manufacturing
Entry Level : Professional