Shelli-Ann Waters
Frederick,MD
Summary
Collaborative leader with dedication to partnering with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings. Versatile Production Supervisor knowledgeable about equipment operation, quality standards and safety hazards. Versed in documentation, compliance and scheduling. Streamlines workflow to maintain productivity and proactively addresses challenges to minimize downtime. Highly skilled with over 20 years of industry experience and knowledge in SAP production for SCMO.
Overview
25
25
years of professional experience
Work History
Manager / Production Supervisor, Clinical Biologics
Astrazeneca / MedImmune, LLC
09.2010 - Current
- Provide immediate supervision for team of five to eight employees
- Responsible for daily operational schedule, overseeing accurate and timely completion of clinical manufacturing and associated cGMP documentation
- Participate in technical transfer, planning, implementation, and maintenance of manufacturing processes and procedures
- Author, edit, review and approve documents in current Enterprise Systems
- Participate in investigations & write up/closures of atypical events using current Enterprise Systems
- Reviews and approves manufacturing production records, standard operating procedures, and solution preparation records
- Create and revise production schedules
- Collaborate and coordinate activities with other groups to facilitate on-time delivery of department production schedule and operation
- Hire, develop, and oversee the performance development process for direct reports
- Work cross functionally across various teams to create, lead and implement process improvements
- Assist in design and execution of projects and new equipment
- Develop training modules and documentation to train staff. Ensures training records for subordinates are accurate and current
- Delegate various tasks as needed
Lead Pilot Production Technician
MedImmune, LLC
11.2007 - 09.2010
- Provide immediate supervision to other second shift technicians on daily basis to ensure compliance to SOP’s, SPR’s or other departmental procedures
- Review various process documents for accuracy and compliance to all GMP policies
- Prepare buffer and media solutions according to defined procedures
- Author/Update/revise various production documents such as SOP’s SPR’s, MPR’s as needed to accurately reflect process steps using validated systems
- Daily schedule assignments for junior personnel
- Assist in training of new junior personnel
- Prepare area production schedule to support department needs
- Complete daily consumption of raw materials and components
- Ensure training records are accurate and up to date
- Assist in trouble shooting and reports issues to relevant personnel for repair
- Orders various minor equipment and supplies as needed
- Coordinate activities with other supporting groups to facilitate area operation
- Other duties as assigned by direct supervisor.
Testing/Laboratory Technician
Merck & Co. Inc.
01.2004 - 07.2007
- Performed in vivo and in vitro potency, safety, toxicity and pyrogen testing using animal models as well as mammalian MRC-5 cell culture assays
- Aseptically prepared growth promoting media for testing
- Aseptically removed animal organs as required for testing and diagnostic purposes
- Performed routine observations for tests’ in progress
- Equipments used include but not limited to microscopes, BSC fume hoods, hemacytometer, centrifuges, tissue homogenizers, incubators, anesthetizing equipment, serological equipment, temperature and CO2 monitoring equipment, culture plates and flasks, general lab equipment
- Maintained complete records of all tests performed and prepared weekly/monthly reports as required
- Performed computer analysis and entered data into designated computer programs
- Assisted in training of new employees and participated in continuing training and education
- Maintained clean, safe and orderly work area in compliance with Good Laboratory Practices, Internal Housekeeping and clean room standards
- Performed routine quality assurance inspections in agreement with FDA regulations.
Biological Technician
Merck & Co. Inc.
05.2001 - 01.2004
- Aseptically removed and prepared stock seed for Fermentation procedures under BL2 environment, using approved Standard Operating Procedures (SOPs) and Manufacturing Process Documents (MPDs)
- Aseptically purified, chemically derivatized and conjugated Microbial fermentation broths, using variety of processes and equipment producing final vaccine product
- Decontaminated, CIP/SIP, prepared, operated and monitored fermentors, process and containment tanks and various other associated process equipment
- Equipment used include but not limited to 70-1000L tanks, high speed centrifuges, dialysis, distillation, ultra and micro filtration equipment, glucose, conductivity and pH meters
- Aseptically removed and tested in process samples as required as well as culture media and raw materials for release and special testing
- Inventoried and maintained supplies and equipment required for processing
- Assisted in development of improved operating methods or process investigations
- Assisted in periodic review and updated all process documents, including MPDs and SOPs
- Observed and performed all safety practices and maintained clean and orderly work area
- Assisted in training of new employees in process operation.
Manufacturing Associate
Merck & Co. Inc.
01.1999 - 05.2001
- Performed operations in production of biological products, culture media and buffer solutions using manual and automated systems
- Equipment used include but not limited to 250-1000L tanks (portable and in-line), homogenizers, centrifuges, ion based chromatography columns, centrifuges, spectrophotometers, filter systems, autoclaves, washers
- Performed various water sampling and environmental monitoring including particle air counting, three point rodac, SMA and compressed air testing
- Assisted in development and review of SOPs, MPDs, other in house documentations as required
- Worked in accordance with all internal and external regulatory requirements including maintaining good housekeeping and Good Manufacturing Practices (GMP)
- Participated in and coordinated training and use of equipment with development and training of new personnel.
Education
Graduate Certificate - Bio-Organic Principles of Pharmaceutical Science
Lehigh University
Bethlehem, PA01.2007
B.A. Biology -
Hood College
Frederick, MD 01.1996
Skills
- Assisted in development of SAP system launch during MINATP
- Created inventory system for team to ensure inventory is accurate and materials are available when needed
- Created and lead SAP Superuser Team for department, standardizing SAP activities across teams
- Inventory Control and Materials Management Manufacturing liaison/SME
- MS Office Suite
- Electronic Learning Systems (Cornerstone)
- Distributed Control System (DCS)
- Process Operations Management Systems (POMS)
- Development Laboratory Information Management Systems (DLIMS)
- Decision-Making
- Schedule Management
- Training and Development
- Project Planning
- Task Delegation
- Verbal and written communication
- Strategic Planning
- Time Management
- Team Development and Leadership
- Employee Coaching and Mentoring
- Hiring and Training
- Complex Problem-Solving and troubleshooting
- Teamwork and Collaboration
- Process Improvement
- Cross-Functional Teamwork
- Documentation And Reporting
- GMP production experience
- Lead Investigator
- Training Program Development
References
Available Upon Request
Timeline
Manager / Production Supervisor, Clinical Biologics
Astrazeneca / MedImmune, LLC
09.2010 - Current
Lead Pilot Production Technician
MedImmune, LLC
11.2007 - 09.2010
Testing/Laboratory Technician
Merck & Co. Inc.
01.2004 - 07.2007
Biological Technician
Merck & Co. Inc.
05.2001 - 01.2004
Manufacturing Associate
Merck & Co. Inc.
01.1999 - 05.2001
Graduate Certificate - Bio-Organic Principles of Pharmaceutical Science
Lehigh University
B.A. Biology -
Hood College
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