Military Veterans are Encouraged to Apply.
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture.
Its products and services are designed to benefit people and improve their quality of life.
At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Production Specialist III Cell Culture Technology Center (CCTC) YOUR TASKS AND RESPONSIBILITIES The primary responsibilities of this role, Product Specialist III CCTC, are to: Be responsible for all aspects of clinical manufacturing in the following areas, Cell Expansion, Cell Culture, Purification, Solution Preparation and Weigh/Dispense; Work seamlessly across all areas and be a Subject Matter Expert (SME) for NLT one area; Participate in New Products Introductions (NPIs) into CCTC with support from Business Development (BD) and MSAT; Ensure all activities are performed to schedule; Act as delegate to Senior Production specialist; Collaborate with BD and MSAT to ensure cross functional alignment with platform process, equipment, raw materials and/or automation for NLT one area; Manufacture products in various phases of product life cycles from clinical thru launch; Understand clearly, communicate and manage differences in terms of documentation, sample handling, automation and Current Good Manufacturing Practice (cGMPs) etc., for different phases of product life cycle; Handle and troubleshoot single use technology (SUT) from end to end in manufacturing process; Monitor and control processes by using data trending and / or statistical process control; Work cross functionally to ensure process is controlled and issues are escalated and investigated; Review authors, redlines and controlled documents for various equipment/processes; Ensure alignment with platform philosophy for CCTC; Assess documentation impact of proposed changes in materials, equipment and provide decision making recommendations for changes; Employ effectively all methods of communication (oral, written, presentation) to ensure knowledge and information transfer across shifts, to management and cross functionally; Create, own and drive business processes of moderate complexity in CCTC; Own and drive to ensure operational readiness and manufacturing of products efficiently; Raise and support investigation of deviations; Partner cross functionally to determine product impact and root cause; Implement and execute manufacturing tasks in alignment with effective corrective actions to prevent re-occurrence; Participate in regulatory and internal audits; Lead internal audit walkthroughs; Perform commissioning and IOPQ of CCTC equipment and execute Commissioning and Qualification documentation.
Participate in safety investigations for CCTC and promote safe behaviors at all times; Partner cross functionally to identify and implement corrective actions; Support development of training curricula and generate training materials for CCTC team; Deliver training as SME; Ensure own training is always in compliance; Look actively for opportunities to improve, propose solutions and encourage same of others; Drive continuous improvements; Challenge 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 in science related field with at least four years of industry experience or Master’s degree or Ph.D.
in science related field with no prior industry experience; Transferable skills or an equivalent combination of education and experience; Demonstrate strong tendency towards independent thinking and decision making; Be able to make logical decisions independently for multiple process work streams with limited information or supervision available; Articulate clearly decision-making process; Work with highest level of flexibility; Respond easily to last minute changes to production schedule; Be able to change shift schedule based on business and process needs; Provide off-hour (night and weekend) coverage to meet business requirements on short notice; Understand functionality of multiple types of equipment such that can troubleshoot and resolve equipment and process related issues independently; Self-motivated; Drive own development, set goals, teach and encourage others; Provide formal and informal feedback; Experience with data integrity, regulatory and cGMP requirements for pharmaceutical manufacturing; Experience with Lean manufacturing principles; Experience with business IT systems; Experience with Microsoft Office; Excellent computer skills; Act as a change agent of equipment with moderate complexity and processes; Apply effective change management; Be able to lift 45 lb.
Preferred Qualifications: Experience in technology transfers or New Product Introduction.
YOUR APPLICATION Bayer offers a wide variety of competitive compensation and benefits programs.
If you meet the requirements of this unique opportunity, and you have the “Passion to Innovate” and the “Power to Change”, we encourage you to apply now.
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.
Location: United States : California : Berkeley Division: Pharmaceuticals Reference Code: 359421