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Production Specialist II Cell Therapy Drug Product 

Production Specialist II - Cell Therapy Cell Culture- Berkeley, CA

PURPOSE

This Production Specialist III is 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. Works with single cell line from expansion, through differentiation and fill/finish process to manufacture unique product using single use technology.

YOUR TASKS AND RESPONSIBILITIES

• Manufactures products in various phases of product life cycles from clinical thru launch;
• Responsible for performing clinical manufacturing in the following areas:
• Solution Preparation, Cell Expansion, Cell Culture, and Final Fill and freezing;
• Will work seamlessly across all areas and be able to execute operations for all areas;
• Handles and troubleshoots single-use technology (SUT) from end to end in the manufacturing process;
• Participates in new products introductions (NPIs) into CT-MOD with support from BD and MSAT;
• Ensures all activities are performed to schedule;
• Acts as a 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;
• Clearly understands, communicates, and manages differences in terms of documentation, sample handling, automation, cGMPs, etc. for different phases of the product life cycle;
• 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;
• Monitors and controls process using data trending and/or statistical process control;
• Work cross-functionally to ensure the process is controlled and issues are escalated and investigated;
• 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;
• Participates in safety investigations for CT-MOD and promotes safe behaviors at all times;
• Partners cross-functionally to identify and implement corrective actions;
• Supports the development of training curricula and generates training materials for the CT-MOD team;
• Ensures own training is always in compliance;
• Actively looks for opportunities to improve, proposes solutions, and encourages 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 QUALIFICATIONS

• BS +4 years, or MS +2 years of related experience in pharmaceutical operations, preferably biotech, or an equivalent combination of education and experience;
• Strong understanding of data integrity, regulatory requirements (FDA, EMA, etc.), and cGMP requirements for pharmaceutical manufacturing;
• Understands all equipment functionality such that can troubleshoot and resolve equipment and process related issues independently;
• Experienced with Lean manufacturing principals;
• Experienced with business IT systems;
• Excellent computer skills; experienced with Microsoft Office Suite of tools (Work, Excel, PowerPoint, Access, etc);
• Acts as a change agent of complex equipment and processes. Applies effective change management;
• Self-motivated/accountable: Pursues everything with a sense of urgency and the commitment to finish. drives own development, sets goals, teaches, and encourages others;
• Highly committed, determined, and results-driven and persist in the face of challenges and setbacks;
• Ability to work on and communicate complex problems in which analysis of situations or data requires evaluation of multiple factors;
• Effective written and verbal communication, networking and presentation skills, to ensure knowledge and information transfer across shifts, to management, and cross functionally;
• Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions;
• Makes sense of and simplifies complex information providing clarity for others to get the job done;
• Able to lead teams and promote team approach;
• Comfortable providing formal and informal feedback;
• Proven ability to build sustainable partnerships to collaborate internally, externally, and cross-functionally to build relationships, influence, recommend, and implement strategies, processes, and procedures;
• Proven ability to act in a speedy and pragmatic manner, adapt quickly to changing environments, without sacrificing quality and long-term goals Must be able to change shift schedule based on business and process needs; provide off-hour (night/weekend) coverage to meet business needs on short notice;
• Demonstrated integrity and a firm commitment to company beliefs and values;
• Treats others with transparency, fairness, and respect;
• Ability to lift 45 lbs / Must meet Occupational Demands/Physical Requirement checklist.

PREFERRED QUALIFICATIONS

• Bachelor’s Degree, preferably in a science-related field;
• Previous experience in technology transfers or New Product Introduction.

Employees can expect to be paid a salary between $80,408.00 to $120,613.00.  Additional compensation may include a bonus or commission (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 11-14-24.