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Production Specialist III Cell Suspension for Injection 

Responsible for clinical manufacturing of novel cell therapy drug substance and drug product within the Cell Therapy Module, CT-MOD. Collaborates closely with biological development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensures platform alignment. Works with various aspects of the CSI and/or Da01 process from expansion through differentiation and fill/finish.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Production Specialist III- Cell Suspension for Injection, are to:

• Responsible for manufacturing in the assigned area which may include, but is not limited to, Solution Preparation, Cell Expansion & Differentiation, Cell Suspension for Injection (CSI), Cell Banking, Drug Product Filling, and Packaging. Primarily assigned to CSI activities,but expected to work across other areas including Da01. Will be an SME for an aspect of the manufacturing process including equipment. Handles and troubleshoots single-use technology (SUT) from end to end in the manufacturing process;
• Manufactures products in various phases of product life cycles from clinical through launch. Develop training curricula and training materials for the CT-MOD team. Delivers training. Ensures own training is always in compliance. Modifies shift patterns & working hours when needed and at short notice to support CSI and surgical requirements;
• Participates as needed in ad-hoc project needs (continuous improvement, site priorities, etc.). May be dedicated to projects when needed.
• Owns and drives manufacturing aspects of projects, including new product introductions (NPIs) into CCTC with support from biologicaldevelopment (BD), and tech transfer teams (MSAT). Collaborates with external & internal partners. Ensures activities are tracked and performed according to schedule; 
• Supports the need to drive the optimization of existing processes to increase efficiencies and meet business needs. Actively looks for opportunities to improve. Creates business processes of moderate complexity. Understand processes related to documentation, sample handling, automation, cGMPs, etc. Trains team on new or optimized processes, equipment, procedures, etc;
• Authors, reviews, and approves controlled documents. Ensures alignment with platform philosophy when appropriate; Assesses owndocumentation for impact when changes in materials & equipment are proposed and provides decision-making recommendations for changes. Performs commissioning and IOPQ of equipment. Review, approve, and execute C&Q documentation;
• Monitors and controls processes using data trending and/or statistical process control where relevant. Works cross-functionally to ensure the process is controlled and issues are escalated and investigated;
• 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;
• Participates in regulatory or internal audits including presentations to auditors;
• Participates in safety investigations for CT-MOD and always promotes safe behaviors. Partners cross-functionally to identify and implement corrective actions.

WHO YOU ARE                                        

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Bachelor’s degree, preferably in a science-related field with relevant pharmaceutical/biotech manufacturing operations experience (transferable skills will be considered);
• Knowledge and expertise in one of the following manufacturing areas is beneficial: weigh & dispense, solution preparation, cell expansion, mammalian cell culture, expansion and differentiation of pluripotent stem cells (allogenic & autologous) in adherent and suspension cultures, formulation of cell therapeutics, sterile drug product filling, packaging & inspection. Cell therapy experience is preferred;
• Experienced with Lean manufacturing principles;
• Previous experience in technology transfers or New Product Introduction is beneficial;
• Strong understanding of data integrity, regulatory requirements (FDA, EMA, etc.), and cGMP requirements for pharmaceutical manufacturing;
• Equipment Troubleshooting: Ability to independently troubleshoot and resolve equipment and process issues;
• Decision-Making: Strong independent thinker who communicates decisions clearly and effectively at all levels;
• Action-Oriented: Demonstrates urgency and commitment, persistent in overcoming challenges;
• Adaptability: Embraces change, seeks improvement opportunities, and adapts to business needs;
• Flexibility: Able to adjust to last-minute changes and provide off[1]hour coverage as needed. Must be able to change shift schedules based on business and process needs. Must provide off-hour (night and weekend) coverage to meet business requirements on short notice;
• Technical Support: Offers technical advice and makes immediate decisions during escalated issues;
• Self-Motivated: Driven to achieve goals, mentors others, and provides feedback;
• Computer Proficiency: Experienced with Microsoft Office and business IT systems;
• Communication Skills: Proficient in oral, written, and presentation communication;
• Continuous Learning: Works in 90-day cycles, applies learnings quickly, and actively seeks feedback;
• Integrity: Upholds company values, treating others with respect and fairness;
• Must meet Occupational Demands/Physical Requirements.

Preferred Experience:

• Bachelor’s degree, preferably in a science-related field with 4 + yrs of relevant pharmaceutical/biotech manufacturing operations experience (transferable skills will be considered), or Master’s degree with 2+ yrs, or an equivalent combination of education and experience;
• Awareness and/or experience of aseptic techniques needed to appropriately operate in a clean room environment.

Employees can expect to be paid a salary of between $77,000 - $105,000.  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 10/18/2024

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