Your tasks and responsibilities
The primary responsibilities of this role,Production Specialist III Cell Culture Technology Center, areto :
Responsible for all aspects of clinical manufacturing in thefollowing areas : Cell Expansion, Cell Culture, Purification,Solution Preparation and Weigh / Dispense.
Employee will workseamlessly across all areas and will be an SME for NLT onearea.
Participates in new products introductions (NPIs) into CCTCwith support from BD and MSAT. Ensures all activities are performedto schedule.
Acts as delegate to Sr. Production specialist.
Collaborates with BD and MSAT to ensure cross functionalalignment with platform process, equipment, raw materials and / orautomation for NLT one area.
Manufactures products in various phases of product life cyclesfrom clinical thru launch. Clearlyunderstands, communicates,and manages differences in terms of documentation, sample handling,automation and cGMPs etc.
for different phases of product lifecycle.
Handles and troubleshoots single use technology (SUT) from endto end in manufacturing process.
Monitors and controls processes using data trending and / orstatistical process control. Works cross functionally to ensureprocess is controlled and issues are escalated andinvestigated.
Authors, redlines and reviews controlled documents for variousequipment / processes. Ensures alignment with platform philosophy forCCTC.
Assesses documentation impact of proposed changes inmaterials, equipment and provides decision making recommendationsfor changes.
Effectively employs all methods of communication (oral,written, presentation) to ensure knowledge and information transferacross shifts, to management, and cross functionally.
Creates, owns, and drives business processes of moderatecomplexity in CCTC. Owns and drives to ensure operational readinessand manufacturing of products efficiently.
Raises and supports investigation of deviations. Partners crossfunctionally to determine product impact and root cause.
Implementsand executes manufacturing tasks in alignment with effectivecorrective actions to prevent re-occurrence.
Participates in regulatory and internal audits. Leads internalaudit walkthroughs.
Performs commissioningand IOPQ of CCTC equipment and executesC&Q documentation.
Participates in safety investigations for CCTC and promotessafe behaviors at all times. Partners cross functionally toidentify and implement corrective actions.
Supports development of training curricula and generatestraining materials for CCTC team. Delivers training as SME. Ensuresown training is always in compliance.
Actively looks for opportunities to improve, proposessolutions, and encouragessame of others. Drives continuousimprovements.
Challenges the status quo and embraces change.
Who you are
Your success will be driven by your demonstration of ourLIFE values. More specifically related to this position,Bayer seeks an incumbent who possesses the following :
Required Qualifications :
BS with 4+ Years of industry experience, or MS or PhD with noprior industry experience
Demonstrates strong tendency towards independent thinking anddecision making. Able to make logical decisions independently formultiple process work streams with limited information orsupervision available.
Clearly articulates decision makingprocess
Works with highest level of flexibility. Respondseasily to last minute changes to production schedule. Must be ableto change shift schedule based on business and process needs.
Mustprovide off-hour (night and weekend) coverage to meet businessrequirements on short notice
Understands functionality of multiple types ofequipment such that can troubleshoot and resolve equipment andprocess related issues independently
Self-motivated. Drives own development, sets goals,teaches and encourages others. Provides formal and informalfeedback
Experienced with data integrity, regulatory, andcGMP requirements for pharmaceuticalmanufacturing
Previous experience in technology transfers or NewProduct Introduction is beneficial
Experienced with Lean manufacturingprinciples
Experienced with business ITsystems
Experienced with Microsoft Office. Excellentcomputer skills
Acts as a change agent of equipment with moderatecomplexity and processes. Applies effective changemanagement