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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.
Prod SpecIII Cell Therapy Cell Culture
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role are to:
- 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 withplatform 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 commissioningand 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
Your success will be driven by your demonstration of our life values, more specifically related to this position, Bayer seeks an incumbent who possesses the following:
Required qualifications:
- Bachelor's Degree, preferably in a science-related field;
- Strong understanding of data integrity, regulatory requirements (FDA, EMA, etc.), and cGMP requirements for pharmaceutical manufacturing;
- Previous experience in technology transfers or New Product Introduction is beneficial;
- 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
Preferred Qualifications:
- BS +4 years, or MS +2 years of related experience in pharmaceutical operations, preferably biotech, or an equivalent combination of education and experience;
- Experience working in a clinical production environment;
- Multi -product facility experience;
- Tech transfer experience
Employees can expect to be paid a salary of approximately $80,700 to $121,000. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc. This salary (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.
#LI-AMSUS
YOUR APPLICATIONBayer 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.
