Senior Production Specialist Cell Suspension for Injection - Bayer Corporation

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Senior Production Specialist Cell Suspension for Injection  

The Senior Production Specialist Cell Suspension for Injection is a subject matter expert (SME) responsible for clinical manufacturing of novel cell therapy drug substance and drug product within the Cell Therapy Module, CT-MOD. In this role you will Collaborate closely with biological development(BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensures platform alignment and will be a technical subject matter expert for aspects of the manufacturing process.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Senior Production Specialist 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 is expected to work seamlessly across other areas as needed and will be an SME for multiple areas. Manufactures products in various phases of product life cycle from clinical through launch. Develops training materials for the CT-MOD team. Delivers training as an SME. Ensures own training is always in compliance. Modifies shift patterns & working hours if needed and at short notice to support CSI and surgical requirements;
• Builds new technical & business processes and/or drives the optimization of existing processes to increase efficiencies and meet business needs. Understands and manages processes related to documentation, sample handling, automation, cGMPs, etc. Trains and coaches team on new or optimized processes, equipment, procedures, etc;
• Participates as needed in ad-hoc project needs (continuous improvement, site priorities, etc.). May be dedicated to high-priority projects for extended periods of time. Leads manufacturing aspects of projects, including new product introductions (NPIs) into CCTC with support from biological development (BD), and tech transfer teams (MSAT). Collaborates with external & internal partners. Ensures activities are tracked and performed according to schedule;
• Manages, handles, and troubleshoots single-use technology (SUT) from end to end in the manufacturing process;
• Authors, reviews, and approves controlled documents. Ensures alignment with platform philosophy when appropriate. Assesses documentation impact of proposed changes in materials, and equipment and Key Tasks: provides decision-making recommendations for changes. Performs commissioning and IOPQ of equipment. Review, approve, and execute C&Q documentation;
• Monitors and controls aspects of manufacturing 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. Ability to make decisions independently where appropriate and/or with minimal supervision. Understand who relevant stakeholders are and seek input when needed;
• Raises and supports investigation of deviations. Partners cross[1]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. • Leads 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;
• 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;
• Strong awareness and/or experience of aseptic techniques needed to appropriately operate in a cleanroom environment. Experienced in single use technology, biological safety cabinets, gowning procedures, etc;
• Thorough working knowledge and application of Good Manufacturing & Documentation Practices;
• Excellent understanding of data integrity, regulatory (FDA, EMA, etc.), and cGMP requirements for pharmaceutical manufacturing;
• 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;
• Technical Support: Offers technical advice and makes immediate decisions during escalated issues. Capable of influencing individuals Skills & Qualifications: outside the manufacturing department to achieve results
• 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;
• Self-motivated: Driven to achieve goals, mentors others, and provides feedback;
• Strong Communication Skills: Proficient in oral, written, and presentation communication;
• Change Agent: Acts as a change agent of complex equipment and processes. Applies effective change management. Capable of influencing individuals outside the manufacturing department to achieve results;
• 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 6  + yrs of relevant pharmaceutical/biotech manufacturing operations experience (transferable skills will be considered), or Master’s degree with 4+ 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;
• Cell therapy experience.

Employees can expect to be paid a salary of between $103,232.80 - $154,849.20.  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 10/28/2024.