Sr. Production Specialist Cell Therapy Cell Culture - Berkeley, CA

Bayer•Berkeley, CA

2d•Onsite

About The Position

This Sr. Production Specialist III is responsible for clinical manufacturing novel cell therapy drug substance within the Cell Therapy Module, CT-MOD. Collaborates closely with biological development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensure platform alignment. Works with single cell line from expansion, through differentiation and fill/finish process to manufacture unique product using single use technology.

Requirements

BS +4 years, or MS +2 years of related experience in pharmaceutical operations, preferably biotech, or an equivalent combination of education and experience
Strong understanding of data integrity, regulatory requirements (FDA, EMA, etc.), and cGMP requirements for pharmaceutical manufacturing
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
Able to lead teams and promote team approach
Comfortable providing formal and informal feedback
Proven ability to build sustainable partnerships to collaborate internally, externally, and cross-functionally to build relationships, influence, recommend, and implement strategies, processes, and procedures
Proven ability to act in a speedy and pragmatic manner, adapt quickly to changing environments, without sacrificing quality and long-term goals Must be able to change shift schedule based on business and process needs; provide off-hour (night/weekend) coverage to meet business needs on short notice
Demonstrated integrity and a firm commitment to company beliefs and values
Treats others with transparency, fairness, and respect
Ability to lift 45 lbs / Must meet Occupational Demands/Physical Requirement checklist

Nice To Haves

Bachelor’s Degree, preferably in a science-related field
Previous experience in technology transfers or New Product Introduction

Responsibilities

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 with platform 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 commissioning and 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