Production Specialist II (CCTC)

Company: Bayer AG
Location: Berkeley
Posted on: March 22, 2025

Job Description:

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'. 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 II (CCTC)Responsible for clinical manufacturing of monoclonal antibodies (mAB) Drug substance within the Cell Culture Technology Center (CCTC). Collaborates closely with sending units and other Manufacturing Science and Technology (MSAT) support functions for new product introductions and ensure platform alignment.YOUR TASKS AND RESPONSIBILITIES

• Work across all areas and unit operations, dedicating efforts towards specific operations as needed. Act as a Subject Matter-Expert (SME) for specific unit operation(s) and/or focused areas.
• Manage all tasks related to New Product Introductions (NPIs) into CCTC that are relevant to their areas of focus, ensuring all activities are performed to schedule.
• Collaborate with the sending unit and MSAT support functions to ensure cross-functional alignment with platform process, equipment, raw materials, and/or automation for specific unit operation(s) and/or areas of focus.
• Manufacture products in various phases of product life cycles from clinical through launch.
• Ensure manufacturing is executed correctly regardless of product and/or life cycle phase.
• Operate the process using Single-Use Technology (SUT) from end to end and troubleshoot all respective SUT for their areas of focus.
• Retrieve, record, and analyze sample results to control processes.
• Monitor processes using data trending for their areas of focus and ensure that all concerns are fully resolved.
• Redline controlled documents for CCTC and incorporate stakeholders' feedback.
• Review documents for their areas of focus and provide feedback to ensure alignment with platform philosophy for CCTC.
• Effectively employ all methods of communication (oral, written, presentation) to ensure knowledge and information transfer across shifts, to management, and cross-functionally.
• Create business processes in CCTC for their areas of focus to ensure efficient manufacturing of products.
• Support investigation of deviations and partner cross-functionally to determine product impact and root cause.
• Participate in regulatory and/or internal audits/walkthroughs as an SME for their areas of focus.
• Perform commissioning of the Installation Operational Performance Qualification (IOPQ) standards of equipment and execute Commissioning and Qualification (C&Q) documentation in their areas of focus.
• Participate in safety investigations for CCTC and promote safe behaviors at all times.
• Support generation of training materials and deliver training as SME for their areas of focus.
• Actively look for opportunities to improve, propose solutions, and encourage the same of others.WHO YOU AREBayer seeks an incumbent who possesses the following:Required Qualifications:
• Bachelor's of science or related field with 2+ years of industry experience.
• Demonstrates strong independent thinking and decision-making.
• Ability to think critically and make logical decisions independently.
• Acts as a change agent of equipment and processes.
• Must work with flexibility to adjust schedules during Active and Non-Active Manufacturing Phases.
• Understands equipment functionality and troubleshoots to resolve equipment/process related issues.
• Self-motivated individual who drives their own development.
• Understands and applies data integrity, regulatory and cGMP requirements.
• Understands and implements Lean manufacturing principles.
• Experienced with business IT systems.
• Excellent computer literacy skills with experience with Microsoft Office Suite.
• Ability to lift 45 lb.Preferred Qualifications:
• Previous experience in technology transfers or New Product Introduction is beneficial.This role operates in a dynamic capacity, adapting to operate on rotating shift schedules for 24/7 coverage during active manufacturing production phases.Shift Days:Sunday - ThursdayTuesday - SaturdayShift Hours:Dayshift: 6am - 3pmSwingshift: 1pm - 10pmNightshift: 9:30am - 6:30amEmployees can expect to be paid a salary of approximately between $65,599 to $98,398. Additional compensation may include a bonus or commission. Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.This posting will be available for application until at least March 6th.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.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).Bayer is an E-Verify Employer.It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment.
  #J-18808-Ljbffr

Keywords: Bayer AG, Berkeley , Production Specialist II (CCTC), Professions , Berkeley, California