Production Specialist III CCTC

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 CCTC

Production Specialist III CCTC Berkeley, CA

PURPOSE

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 of this role are to :

• Responsible for all aspects of clinical manufacturing in the following areas : Cell Expansion, Cell Culture, Purification, Solution Preparation and Weigh / Dispense.
• Employee will work seamlessly across all areas and will be an SME for NLT one area;
• Participates in new products introductions (NPIs) into CCTC with support from BD and MSAT. Ensures all activities are performed to schedule.
• Acts as delegate to Sr. Production specialist;
• Collaborates with BD and MSAT to ensure cross functional alignment with platform process, equipment, raw materials and / or automation for NLT one area;
• Manufactures products in various phases of product life cycles from clinical thru launch;
• Clearly understands, communicates, and manages differences in terms of documentation, sample handling, automation and cGMPs etc.
• for different phases of product life cycle;
• Handles and troubleshoots single use technology (SUT) from end to end in manufacturing process;
• Monitors and controls processes using data trending and / or statistical process control. Works cross functionally to ensure process is controlled and issues are escalated and investigated;
• Authors, redlines and reviews controlled documents for various equipment / processes. Ensures alignment with platform philosophy for CCTC.
• Assesses documentation impact of proposed changes in materials, equipment and provides decision making recommendations for changes;
• Effectively employs all methods of communication (oral, written, presentation) to ensure knowledge and information transfer across shifts, to management, and cross functionally;
• Creates, owns, and drives business processes of moderate complexity in CCTC. 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. Leads internal audit walkthroughs;
• Performs commissioning and IOPQ of CCTC equipment and executes C&Q documentation;
• Participates in safety investigations for CCTC and promotes safe behaviors at all times. Partners cross functionally to identify and implement corrective actions;
• Supports development of training curricula and generates training materials for CCTC team. Delivers training as SME. 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

Bayer seeks an incumbent who possesses the following :

REQUIRED QUALIFICATIONS

• BS in science related field with 4+ Years of industry experience, or MS or PhD in science related field with no prior industry experience;
• Transferable skills will be considered; or an equivalent combination of education and experience;
• Demonstrates strong tendency towards independent thinking and decision making;
• Able to make logical decisions independently for multiple process work streams with limited information or supervision available;
• Clearly articulates decision making process;
• 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 functionality of multiple types of equipment such that can troubleshoot and resolve equipment and process related issues independently;
• Self-motivated. Drives own development, sets goals, teaches and encourages others;
• Provides formal and informal feedback;
• Experienced with data integrity, regulatory, and cGMP requirements for pharmaceutical manufacturing;
• Experienced with Lean manufacturing principles;
• Experienced with business IT systems;
• Experienced with Microsoft Office;
• Excellent computer skills;
• Acts as a change agent of equipment with moderate complexity and processes;
• Applies effective change management;
• Ability to lift 45 lb.

PREFERRED QUALIFICATIONS

• Previous experience in technology transfers or New Product Introduction is beneficial;
• Experience in downstream process (DSP) such as ProA, AEX, CEX, Viral Filtration, and TFF, Delta V, Single use.

Employees can expect to be paid a wage between $86,568.00 and $123,852.00. Additional compensation may include a bonus or commission (if relevant).

Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.. This wage 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 open for applications until at least 6-14-24