Alandis Whitley
Rosedale,MD
Summary
Well-organized and enthusiastic candidate with good communication, problem-solving skills, and dependability. Successful at managing multiple priorities with a positive attitude, highly skilled in aseptic techniques and ISO environments, and has shown a willingness to take on added responsibilities to meet team goals.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Biologist (full-time)
ATCC
07.2023 - 04.2024
- Performed cell expansion runs with adherent and suspension cell lines and handled clinical samples starting from repository release to freeze down
- Shadowed research and development production runs and startup of virology training
- Maintained and ensured new production batch records were in compliance with GLP, and accurate in documentation for future reference and analysis
- Revised and developed SOPs, work instructions and created new forms used in improving all bioprocessing
- Collected, analyzed, and reported data from production orders by use of tec transfer
- Implemented, monitored and organized 6s audits in research and development suites in pursuit of ISO environments
- Conducted equipment experimentation to determine relevancy, compatibility with current processes and reproducibility
- Adhered to strict documentation and gained familiarity in justification process
- Created change requests and implemented it's changes
- Familiar and experienced with cryopreservation, ordering equipment and warehouse duties
- Assisted in some QC activities such as environmental monitoring when needed
- Regularly attend biweekly/monthly team meetings to present current data of individualized and collaborative work in efforts to adhere to deadlines
Manufacturing Associate II (full-time)
Catalent Pharma Solutions
10.2022 - 03.2023
- Excellent documentation skills
- Cross trained in cell expansion, buffer prep, and some fill finish exposure
- Well versatile in GLIMS, QAD and familiar with JED
- Interacted and escorted clients on guided tours of manufacturing floor
- Profound knowledge and understanding of harvest, bioreactor, and passage operations
- Assisted in revisions of SOPs and review of batch records in accordance with GMP regulation
- Demonstrated thorough understanding and knowledge of multiple processes and order of operation
- Experienced in troubleshooting equipment and operational issues pertaining to cell culture processing
- Assisted in deviation investigations
- Used preemptive measures for verification and reported findings back to supporting personal
- Participated in regular team meetings to discuss progress, address challenges, and align on strategies for achieving production goals
- Observed production deadlines with timely delivery of production goals and objectives
- Met tight deadlines through effective time management skills prioritizing tasks based on their importance related overall success operation
- Maintained accurate production records for analysis purposes, ensuring traceability of products throughout entire manufacturing process
- Performed general equipment maintenance to reduce downtime
- Trained new production staff members on safe and efficient production procedures and proper machine operations
Manufacturing Associate I (full-time)
Catalent Pharma Solutions
05.2020 - 10.2022
- Exceptional in GDP, laboratory work and cGMP ventures regarding upstream production and operations
- Utilize basic knowledge and use of cGMP to proactively gain awareness on validations, deviations, and change controls
- Discipline in using single-use bioreactors (Sartorius, WAVE, Xcellerex) in relation to suspension and adherent cell cultures
- Proficient and knowledgeable in manufacturing purification process, equipment recognition, sample submission, batch record support, and safety procedures
- Proactively demonstrated effective communication skills and teamwork through assisting others, volunteering for processing, and gaining needed knowledge to help convey sensitive information to future trainees
- Made sure that products were produced on time and are of good quality
- Operated various types of machinery efficiently while adhering to all safety protocols at all times during shifts worked alongside other employees working together towards shared objectives
- Ensured workplace safety by following all company guidelines, participating in regular safety audits, and promptly addressing hazards as they arose
- Developed strong working relationships with colleagues, in order to foster positive team environment that facilitated open communication and collaboration on projects
Problem Solver (IT) (full-time)
Amazon
06.2019 - 05.2020
- Study and observe various computational tools and programs to locate materials in orders; Proficient in multitasking and group collaborations
- Initiated, investigated, and authored production dispatch and recovery
- Defined problem to identify, prioritize and select alternatives
- Employed various tools and equipment to find solutions to difficult or complex issues
- Collaborated with cross-functional teams to identify, analyze, and resolve complex issues impacting business performance
- Conducted root cause analysis on recurring problems and developed long-term solutions that prevented future occurrences
Education
Bachelor of Science in Biology -
Towson University
Towson, MD12.2018
Skills
- Data Analysis
- Critical Thinking
- Data Collection
- Cell Culture Techniques
- Bioreactor Operation
- Equipment Maintenance
- Project Coordination
- Teamwork
- Time Management
- Constructive Feedback
- Emotional Intelligence
- Active Listening
Certification
- Understanding ISO 9001:2015, Plexus International
- Lean Six Sigma White Belt, LinkedIn Learning
- Lean Six Sigma Yellow Belt, LinkedIn Learning
- cGMP: An Introduction to Good Manufacturing Practices, Biopharma Institute
- cGMP: Warehouse for Pharmaceuticals, Biopharma Institute
- cGMP: Microbiology in the Workplace, Biopharma Institute
- cGMP: Cleaning and Sanitation, Biopharma Institute
- cGMP: Contamination Control, Biopharma Institute
- cGMP: Production Controls, Biopharma Institute
- cGMP: Packaging Controls, Biopharma Institute
- cGMP: Documentation and Record Keeping, Biopharma Institute
- cGMP: Quality Assurance and Quality Control, Biopharma Institute
- cGMP: Data Integrity, Biopharma Institute
- cGMP: Pharmaceutical CAPAs, Biopharma Institute
- Current Good Manufacturing Practice (cGMP), Biopharma Institute
PROCEDURAL AND TECHNICAL SKILLS
• Experienced using molecular, microbiology, and organic chemistry techniques such as, but not limited to:
Polymerase Chain Reaction (PCR), Gel Electrophoresis, SDS-PAGE, Western; Northern and Southern Bolt, Microbial Staining, Plating, Streaking,Purification, Column Chromatography, TLC Plates, Reflux, and Distillation Method
• Knowledgeable of biosafety regulations regarding aseptic techniques, and work area safety
• Proficient in pharmaceutical development and manufacturing in both bioreactor and harvest processing and equipment use regarding:
Scales, Pipet, Pumps, Sample Submission, Wave, Bioreactor, Vicell, Biological Safety Cabinet (BSC), Water Bath,Microscope, Cell Adherence, Pod Filters, pH/ Conductivity, KTF, Single-Use Mixer, iCellis, Lauda Temperature Control Unit (TCU), Mixer and Magnetic Drive, Tube sealers, Biowelders, Terumo, Clipster and Nova
Timeline
Biologist (full-time)
ATCC
07.2023 - 04.2024
Manufacturing Associate II (full-time)
Catalent Pharma Solutions
10.2022 - 03.2023
Manufacturing Associate I (full-time)
Catalent Pharma Solutions
05.2020 - 10.2022
Problem Solver (IT) (full-time)
Amazon
06.2019 - 05.2020
Bachelor of Science in Biology -
Towson University
- Understanding ISO 9001:2015, Plexus International
- Lean Six Sigma White Belt, LinkedIn Learning
- Lean Six Sigma Yellow Belt, LinkedIn Learning
- cGMP: An Introduction to Good Manufacturing Practices, Biopharma Institute
- cGMP: Warehouse for Pharmaceuticals, Biopharma Institute
- cGMP: Microbiology in the Workplace, Biopharma Institute
- cGMP: Cleaning and Sanitation, Biopharma Institute
- cGMP: Contamination Control, Biopharma Institute
- cGMP: Production Controls, Biopharma Institute
- cGMP: Packaging Controls, Biopharma Institute
- cGMP: Documentation and Record Keeping, Biopharma Institute
- cGMP: Quality Assurance and Quality Control, Biopharma Institute
- cGMP: Data Integrity, Biopharma Institute
- cGMP: Pharmaceutical CAPAs, Biopharma Institute
- Current Good Manufacturing Practice (cGMP), Biopharma Institute
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