CHRISTOPHER NEWELL
Whitsett,NC
Summary
Highly motivated and diligent cell culture technician with over a decade of extensive experience working under strict GMP regulations and following SOP guidelines. Interested in microbiology and Cell Culture Purification, excels in producing requirements by operating and monitoring equipment, observing varying conditions, adjusting equipment controls, and calculating concentrations, dilutions, and yields while adhering to aseptic procedures. Expertise also includes preparing equipment through cleaning-in-place (CIP), steaming-in-place (SIP), and manual cleaning. Proven leader with strong project management and development abilities, drive to achieve success and increase productivity through process improvements. Strong work ethic and commitment to compliance with professional codes, regulations, and company policies, dedicated to delivering exceptional results in the field of cell culture technology.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Downstream Cell Culture Technician III
Fujifilm Diosynth Biotechnolgies Inc.
05.2021 - Current
- Maintained a safe work environment by strictly adhering to established safety protocols and guidelines.
- Performs basic Downstream purification and mRNA production activities, such as in-vitro transcription (IVT) reactions, chromatography, tangential flow filtration (TFF), viral filtration, and column packing and qualification
- Trained new technicians on standard operating procedures, ensuring consistency across the team.
- Accurately follows manufacturing Batch Production Records (BPRs) and Standard Operating Procedures (SOPs) in accordance with current Good Manufacturing Practices (cGMPs)
- Documents all activities in accordance with Good Documentation Practices (GDPs) in BPRs, Forms, and other quality documentation
- Maintained a safe and clean work environment by following cGMP and complying with legal regulations
Material Control Coordinator II
Fujifilm Diosynth Biotechnologies Inc.
02.2019 - 10.2021
- Execute shipping and receiving procedures for all GMP and Non-GMP materials and/or finished products
- Conduct Raw Material and Gas sampling and receive verification and staging of Raw Materials, Acids, Caustic and Consumables
- In charge of properly labeling and staging of dispensed materials for manufacturing purposes
- Clean equipment and perform formulation or Batch record materials issuance calculations
- Supported transitions from legacy ERP systems to SAP including data and process conversion
- Transport raw materials and consumables and perform other duties as assigned.
- Reduced waste in the supply chain by identifying areas of excess and optimizing resources usage.
- Effectively resolved any discrepancies or issues related to material supply in a timely manner ensuring minimal disruption to production processes.
Aseptic Filling Core Technician II
GRIFOLS Therapeutics
06.2016 - 01.2019
- Responsible for line set-up, cleaning and changeover of equipment within all manufacturing areas
- Examined supplies meticulously to ensure that they are properly cleaned and sanitized
- Perform inventory cycle counts and transactions for specified periods of time
- Performed facility cleaning of critical aseptic environment to maintain a cGMP environment and in accordance with SOPs
- Provided support to manufacturing runs including material handling, inventory management, and equipment/ cleanroom cleaning
- Provided feedback to engineering and scientific staff on process performance and ideas for process improvement
- Followed safety and environmental procedures and used all precautions necessary to have an injury free workplace.
Equipment Prep Technician
Mallinckrodt Imaging
03.2010 - 08.2015
- Exhibited time management skills in prioritizing tasks effectively under tight deadlines without sacrificing attention to detail or quality of work output.
- Implemented shipping and receiving procedures for all GMP and non-GMP materials and products
- Performed inventory cycle counts and transactions within a specified time period
- Maintained a safe and clean work environment by following cGMP and complying with legal regulations
- Responsible for completing paperwork for each task, cleaning procedures, aseptic processing techniques, Good Manufacturing Practices (GMP) and laboratory safety practices and procedures.
- Continuously expanded professional expertise through attending relevant training courses, webinars, conferences, or workshops related to the field.
Education
BFA Graphic Design -
The Art Institute of Charlotte
Charlotte, NC05.2010
High School Diploma -
Ben L. Smith
Greensboro, NC06.2006
Skills
- Exceptional knowledge of microbiology techniques for micro culture growth, research and data interpretation
- ERP/Purchasing Receipts and ordering
- Maintaining safe and clean work environment by following current good manufacturing practices
- Exceptional organization skills with ability to prioritize and manage multiple tasks simultaneously
- Skilled in counseling, problem-solving and conflict management to ensure smooth workflow
- Solid time management with high precision in delivery in a deadline-oriented environment
- Strong written and verbal communication skills for documentation and correspondence
- Outstanding interpersonal skills with strong team spirit and great respect for diversity
- Maintain accurate and accessible records on incoming and outgoing product
- Proficient in Computer systems: PAS-X, SAP and MS Office suite (Word, Excel, PowerPoint)
- Customer Service
- Works Well Under Pressure
Certification
- Wake Tech. Community College, Aseptic Processing 1, 06/01/14
- Wake Tech. Community College, Aseptic Processing 11, 06/01/14
Skillshighlights
- GMP Documentation & Record Keeping
- Equipment Operation & Monitoring
- CGMP & Standard Operating Procedures
- Safety Protocols
- Problem Solving
- Critical Thinking
- Laboratory Management
- Highly Detail Oriented
- Coordination & Collaboration
- Training & Development
- Operations Management
- Team Leadership
- Flexible & Dedicated
- Supervision & Follow-up
- Regulatory Compliance
Timeline
Downstream Cell Culture Technician III
Fujifilm Diosynth Biotechnolgies Inc.
05.2021 - Current
Material Control Coordinator II
Fujifilm Diosynth Biotechnologies Inc.
02.2019 - 10.2021
Aseptic Filling Core Technician II
GRIFOLS Therapeutics
06.2016 - 01.2019
Equipment Prep Technician
Mallinckrodt Imaging
03.2010 - 08.2015
BFA Graphic Design -
The Art Institute of Charlotte
High School Diploma -
Ben L. Smith
- Wake Tech. Community College, Aseptic Processing 1, 06/01/14
- Wake Tech. Community College, Aseptic Processing 11, 06/01/14
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