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Manufacturing Specialist III 

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 

The primary responsibilities of this role are to:   

Responsible for performing clinical manufacturing in the following areas: Solution Preparation, Cell Expansion, Cell Culture, and Final Fill and freezing. Employees will work seamlessly across all areas and be able to execute operations for all areas. 

Participates 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. 

Collaborates with BD and MSAT to ensure cross functional alignment with platform process, equipment, raw materials and/or automation for NLT one area. 

Manufacturing products in various phases of product life cycles from clinical through launch.  

Clearly understands, and communicates, differences in terms of documentation, sample handling, automation and GMPs etc. for different phases of product life cycle. 

Handles and troubleshoots 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 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 business processes of moderate complexity in CT-MOD. Owns and drives 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. Implements and executes manufacturing tasks in alignment with effective corrective actions to prevent re-occurrence. 

Participates in regulatory and internal audits.  

Performs commissioning and IOPQ of CT-MOD equipment and executes C&Q documentation under supervision. 

Participates in safety investigations for CT-MOD and promotes safe behaviors at all times. Partners cross functionally to identify and implement corrective actions.   

Supports development of training curricula and generates training materials for CT-MOD team. Delivers training as SME. Ensures own training is always in compliance. 

Actively looks for opportunities to improve, proposes solutions, and encourages the same of others. Drives continuous improvements. Challenges the status quo and embraces change. 

WHO YOU ARE 

Bayer seeks an incumbent who possesses the following: 

Required: 

Bachelors of Science in science related field with 4+ years of industry experience, or MS or PhD in science related field with no prior industry experience  

Transferable skills and equivalent combination of education and experience will be considered in lieu of the requirements listed above

Proven experience adhering to Good Manufacturing Practice (GMP), Good Documentation Practices (GDP) and Aseptic Techniques in a production environment 

Preferred: 

Takes ownership of responsibilities and is accountable for actions 

Flexible and adaptable to quickly adjust priorities for critical requirements 

Excels in collaboration and demonstrates strong interpersonal skills, fostering effective teamwork. 

Employees can expect to be paid a salary between $80,067 to $120,010. Additional compensation may include a bonus or commission (if relevant).  Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc..  This salary (or 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 March 3rd. 

YOUR APPLICATION

If your background and personal experience fit this profile, please send us your complete application at www.career.bayer.cn If you have any recommendations, please kindly send mail to cnreferral@bayer.com
 

Location:                   

United States : California : Berkeley 

Division:

Pharmaceuticals 

Reference Code:

838980