**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.** **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, DrugProduct Filling, and Packaging. Primarily assigned to CSI activities,but expected to work across other areas including Da01. Will be an SMEfor an aspect of the manufacturing process including equipment. Handlesand troubleshoots single-use technology (SUT) from end to end in themanufacturing process; + Manufactures products in various phases of product life cyclesfrom clinical through launch. Develop training curricula and training materials for the CT-MOD team. Delivers training. Ensures own trainingis always in compliance. Modifies shift patterns & working hours whenneeded and at short notice to support CSI and surgical requirements; + Participates as needed in ad-hoc project needs (continuousimprovement, site priorities, etc.). May be dedicated to projects whenneeded. + Owns and drives manufacturing aspects of projects, including newproduct introductions (NPIs) into CCTC with support from biologicaldevelopment (BD), and tech transfer teams (MSAT). Collaborates withexternal & internal partners. Ensures activities are tracked andperformed according to schedule; + Supports the need to drive the optimization of existingprocesses to increase efficiencies and meet business needs. Activelylooks for opportunities to improve. Creates business processes ofmoderate complexity. Understand processes related to documentation,sample handling, automation, cGMPs, etc.Trains team on new oroptimized processes, equipment, procedures, etc; + Authors, reviews, and approves controlled documents. Ensuresalignment with platform philosophy when appropriate; Assesses owndocumentation for impact when changes in materials & equipment areproposed and provides decision-making recommendations for changes.Performs commissioning and IOPQ of equipment. Review, approve, andexecute C&Q documentation; + Monitors and controls processes using data trending and/orstatistical process control where relevant. Works cross-functionally toensure the process is controlled and issues are escalated andinvestigated; + Raises and supports investigation of deviations. Partnerscross-functionally to determine product impact and root cause. Owns andimplements effective corrective actions to prevent re-occurrence; + Participates in regulatory or internal audits includingpresentations to auditors; + Participates in safety investigations for CT-MOD and alwayspromotes safe behaviors. Partners cross-functionally to identify andimplement 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 ProductIntroduction is beneficial; + Strong understanding of data integrity, regulatory requirements(FDA, EMA, etc.), and cGMP requirements for pharmaceutical manufacturing; + Equipment Troubleshooting: Ability to independently troubleshoot andresolve 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 inovercoming 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 onbusiness 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 immediatedecisions during escalated issues; + Self-Motivated: Driven to achieve goals, mentors others, and providesfeedback; + Computer Proficiency: Experienced with Microsoft Office and businessIT systems; + Communication Skills: Proficient in oral, written, and presentation communication; + Continuous Learning: Works in 90-day cycles, applies learningsquickly, 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 operationsexperience (transferable skills will be considered), or Master’s degreewith 2+ yrs, or an equivalent combination of education and experience; + Awareness and/or experience of aseptic techniques needed toappropriately 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 \#LI-AMSUS **YOUR APPLICATION** Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer. To all recruitment agencies: Bayer does not accept unsolicited third party resumes. Bayer is an Equal Opportunity Employer/Disabled/Veterans Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. Bayer is an E-Verify Employer. **Location:** United States : California : Berkeley **Division:** Pharmaceuticals **Reference Code:** 831257 **Contact Us** **Email:** hrop_usa@bayer.com **Job Segment:** Pharmaceutical, Industrial, Compliance, Biology, Biotech, Science, Manufacturing, Legal