1. CHARLES M. HENDERSON
Mark.hendu@gmail.com • 843-591-5617
Results-oriented Manufacturing Technical Support Specialist with 10 years of experience in both hands-on
manufacturing operations and technical support experience in all aspects of API/Intermediate drug
manufacturing in a multi-purpose production facility. Extensive knowledge and expertise in technical
operations/manufacturing support, product quality and compliance, manufacturing, technology transfer,
qualification and validation.
• Thrive in both independent and cross-functional work environments.
• Goal-driven and self-motivated with a positive attitude.
• Recognized for being people-oriented and collaborating on multiple, large-scale projects simultaneously;
aggressively meeting project milestones with a high level of quality.
• Mentor and train staff on pharmaceutical processing techniques and electronic compliance system
applications.
• SOP Development • Quality Process Change Control • Discrepancy Management • Root Cause Analysis •
Product Impact Assessments • CAPA • Continuous Process Improvement • Documentation/Compliance •
Manufacturing • Product Tech Transfer • Qualification Lifecycle • Quality Risk Management • Project
Management • Process Training • Regulatory Audit Support • Process Hazard Analysis •
PROFESSIONAL EXPERIENCE
ROCHE CAROLINA INC. – Florence, SC 2006 – Present; produces small molecule Active Pharmaceutical
Ingredient
Produces API products including Xeloda, Tamiflu, Esbriet, and Pegasys; ~ 200 employees (Florence site)
MANUFACTURING TECHNICAL SUPPORT SPECIALIST - 2014
Team member in the Manufacturing Technical Support Group. Provide manufacturing technical support and
project execution for the large scale manufacturing department in order to drive the overall
quality/compliance and throughput of API manufacturing. Responsible for all facets of technical support
including the development and implementation of all Manufacturing Quality Risk Management activities
(FMEA), Leading Site qualification (IQ/OQ), Resolution of Product Incident Investigations, Implementation
of CAPAs, Technology Transfer of Products, evaluation of new equipment technologies, development of SOPs
and support of Regulatory audits. Responsible for implementing compliance projects and process
improvements in a cross functional environment between Manufacturing, Engineering, Quality, Maintenance,
and MSAT departments.
Key Achievements:
• Support the efforts to identify process fit for new technology transfer projects.
− Extended Team member for the Technology Transfer of Esbriet. Recognized for the successful
completion of the transfer of all three processing steps from an outside CMO to Roche Carolina.
− Completed Quality Risk Assessments, Process Hazard Analyses, Installation and Operational
Qualifications, development of process training and other related procedures.
− Draft/Revise and review User Requirement Specification documents, System Impact
Assessments, Traceability Matrices, Criticality Assessments and Extended Criticality
Assessments as required by Engineering/Validation.
Continued…

2. • Support continuous improvement and compliance effort within the manufacturing processes by
implementation of approved initiatives (including process updates and training), through appropriate
change control process.
Charles M. Henderson • Page 2
mark.hendu@gmail.com • 843-591-5617
• Completed and supported quality risk assessments for all legacy manufactured products (FMEAs).
• Provided end to end support for the installation of new equipment to support the completion of Capital
Projects:
− Supported the development of the Qualification Project Plan (QPP)
− Completed System Impact Assessments (SIAs) and Criticality Assessments (CAs)
− Supported completion of the Design Qualification (DQ)
− Orchestrated Installation and Operational Qualifications including the development of Batch
Recipes in Batch Studio to support Operational Qualifications
− Authored Qualification Summary Reports (QSRs)
• Author of Manufacturing Standard Operating Procedures (Updating and Revision) to align manufacturing
technique across all manufacturing processes..
Technical Support Computer System Proficiencies :
• TrackWise (Discrepancy, Change Control, CAPA)
• Batch Studio (Recipe Writing Software) for the manufacture of API/Intermediate products.
• DCS (Automated Process Control)
• Process Book (Process Trending)
• ConDor (GMP Document Management)
• ProjectWise (Engineering Documentation Management System)
• STATURE (Quality Risk Management System)
SENIOR MANUFACTURING TECHNICIAN 2006-2013
Perform all duties in the manufacturing of intermediate and API products in multiple MPU’s (multi-purpose
production unit). Responsible for the production of Xeloda intermediate and API product (meeting production
schedules and requirements). Make recommendations regarding improving process operations. Monitor all
operations of designated chemical process to ensure safe chemical procedures, quality standards and
compliance with regulatory requirements. Accurately record and analyze against standards all processing data
gathered from instruments, DCS, PLC’s, Pi, LIMS, BDR, etc. to ensure operating standards are met; Make
approved adjustments as appropriate to maintain process parameters within designated limits. Troubleshoot
DCS and solve problems in the field. Actively participate in problem-solving regarding process issues and
continuous improvement.
Key Achievements:
• Completed an apprenticeship for the occupation of Chemical Operator III through the United States
Department of Labor on June 15, 2011.
• Mentored and coached newer Process Technicians and assisted where applicable in skill
completion/assessments.

3. • Administered, documented and maintained the Roche Carolina Quality Systems conformance to
regulatory requirements and company policies through effective utilization of Trackwise and ConDor
Quality Systems tools.
• Supported the launch of the 3000 Multi-Purpose Production Unit (MPU) by coordinating and completing
start-up and commissioning activities. Start-up of this MPU increased the production capacity of the site
by ~50%.
• Manufactured Xeloda, Capecitabine API and Intermediate products in all four MPUs (300, 750, 2000 and
3000 gallon process units). Provided technical expert floor support and DCS management for driving
automated manufacturing unit operations including chemical reaction, filtration, distillation,
centrifugation, crystallization and drying/packaging processes.
• Provided feedback to Shift Leader in areas of improvement regarding safety (implementing step stools in
production bays).
• Worked on new, short-run, processes that required versatility in skill and knowledge of production
equipment. Products included Tigason, Cat-Nitrile, HCV-11, and MBG.
• Certified fork truck and aerial lift operator.
BENETEAU USA – Marion, SC 1999 – 2006; Manufactures high end sail boats
LAMINATION CREW LEADER
Responsible for the lamination of various size sailboats, up to 50 ft. in length. Lead a crew of four people
in proper lamination techniques following set patterns and procedures. Ensure safe handling of a wide
variety of chemicals including Acetone, MEKP, MEK, alcohols and several resins. Demonstrated a high
level of leadership to ensure boats were free from defect and the work area was clean and well
maintained.
• Completed a certification as a Certified Composites Technician.
• Certified crane and hydraulic mold operator.
Arvin Meritor – Marion, SC 1998 – 1999; Manufactures parts for all major car companies
MATERIAL HANDLER
Handled containers of various sizes to keep the production lines running smoothly and on time.
Maintained the labeling of parts bins to ensure proper shipping.
• Developed and implemented many suggestions that improved productivity and overall floor cleanliness.
• Participated in all activities to ensure the site became ISO 9001 certified.
UNITED STATES MARINE CORPS 1994-1998
SQUAD LEADER
Infantry rifleman with the 6th
Marine Regiment. Advanced to the rank of E-4 in two years. Supervised up
to 12 Marines in proper training techniques both in field operations and technical operations. Maintained
the moral and physical fitness of my squad.
• Marine Marksmanship Instructor
• Certified as an Assault Climber
• Stationed aboard a USN Vessel for a 6 month deployment to the Mediterranean including training
in Africa, Bulgaria, Spain, Italy, France, and Israel.