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Production Specialist II Cell Culture Technology Center
As the Production Specialist II Cell Culture Technology Center you will be responsible for clinical manufacturing of monoclonal antibodies (mAB) Drug substance within the Cell Culture Technology Center (CCTC). Collaborates closely with biological development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensure platform alignment.
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities for this role Production Specialist II Cell Culture Technology Center are to:
Responsible for working across all areas and unit operations but maybe dedicated to specific operations as needed. Employee will be an SME for specific unit operation(s) and/or focused areas; Responsible for all tasks related to NPIs into CCTC that are relevant to their areas of focus. Ensures all activities are performed to schedule. Acts as delegate to Production specialist II;Collaborates with BD and MSAT to ensure cross functional alignment with platform process, equipment, raw materials and/or automation for specific unit operation(s) and/or areas of focus;Manufactures products in various phases of product life cycles from clinical thru launch;Manages differences between multiple products. Ensures manufacturing is executed correctly regardless of product and/or life cycle phase;Operates the process using SUT from end to end. Troubleshoots single use technology (SUT) for their areas of focus;Retrieve, record, and analyze sample results to control processes;Monitors process using data trending for their areas of focus. Works cross functionally to ensure process is in control. Follows through to ensure all concerns are fully resolved;Redlines controlled documents for CCTC and incorporates stake-holders feedback. Reviews documents for their areas of focus and provides feedback to ensure alignment with platform philosophy for CCTC;Effectively employs all methods of communication (oral, written, presentation) to ensure knowledge and information transfer across shifts, to management, and cross functionally;Creates business processes in CCTC for their areas of focus to ensure manufacturing of products efficiently. Challenge status quo and provides continuous feedback for improvements;Supports investigation of deviations. Partners cross functionally to determine product impact and root cause. Executes manufacturing tasks in alignment with effective corrective actions to prevent re-occurrence. Participates in regulatory and/or internal audits/walkthroughs. Acts as SME for their areas of focus;Performs commissioning and IOPQ of equipment and executes C&Q documentation in their areas of focus;Participates in safety investigations for CCTC and always promotes safe behaviors. Partners cross functionally to identify and implement corrective actions;Supports generation of training materials and delivers training as SME for their areas of focus. Ensures own training is always in compliance;Actively looks for opportunities to improve, proposes solutions, and encourages same of others. Drives continuous improvements their areas of focus. Challenges the status quo and embraces change.
WHO YOU ARE
Required Qualifications:
Bachelors Degree; Demonstrates strong tendency towards independent thinking and decision making. Able to make logical decisions independently for their areas of focus utilizing established procedures, own experience, and education; Works with highest level of flexibility. Responds easily to last minute changes to production schedule. Must be able to change shift schedule based on business and process needs. Must provide off-hour (night and weekend) coverage to meet business requirements on short notice;Understands equipment functionality and troubleshoots to resolve equipment/process related issues independently within their areas of focus;Self-motivated. Drives own development, sets goals, teaches and encourages others. Provides formal and informal feedback;Understands and applies data integrity, regulatory and cGMP requirements for pharmaceutical manufacturing; Previous experience in technology transfers or New Product Introduction is beneficial; Understands and implements Lean manufacturing principles; Experienced with business IT systems;Experienced with Microsoft Office. Excellent computer skills;Acts as a change agent of equipment and processes within their areas of focus. Applies effective change management;Ability to lift 45 lb.
Preferred Qualifications:
BS in science related field with 2+ Years of industry experience.
Employees can expect to be paid a salary between $65,599.20 - $98,398.80. Additional compensation may include a bonus or commission (if relevant). Other benefits include health care, vision, dental, retirement, PTO, sick leave, etc. If selected for this role, the offer may vary based on 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 11-21-2024
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.
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:833138 Contact Us Email:hrop_usa@bayer.com