Lakishia S. James
Gaithersburg,MD
Summary
Effective leader with extensive knowledge of process optimization, and increase productivity. Assertive and enthusiastic with unsurpassed work ethic. Detailed- oriented team player with experience in coordinating projects, programs and improvements. Strong background in safety procedures, processes, and regulations. Experience working with teams to achieve short and long-term project goals.
Overview
25
25
years of professional experience
Work History
Scientist (Level II)
Biologics Laboratory, United States Pharmacopeia
08.2021 - Current
- Write and review project reports on biological studies of reference standards for drug products.
- Conduct studies and scientific experiments for large spectrum of assays in the laboratory which establish quality attributes for drugs, including microbiological assays, identification testing, such as SDS-PAGE, Compendia assays such as pH, Appearance, and Water Content, UV-Vis for protein content measurements (A280)
- Participate in international collaborative studies establishing WHO International Standards
Scientist
Biologics Laboratory, United States Pharmacopeia
04.2014 - 08.2021
- Conducted experiments in laboratory environment with a heavy focus on microbiological assays to establish quality attributes for antibiotics.
- Documented changes during experiments, noting unexpected issues arising during research activities.
- Evaluated and implemented new technologies and laboratory techniques to improve assay procedures.
- Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
Associate Scientist
Biologics Laboratory, United States Pharmacopeia
04.2008 - 04.2014
- Perform scientific assays and procedures for drug products
- prepare solutions and preparations and agar plates for testing.
- Prepared samples for analytical testing using sterile techniques in BSL-2 laboratory setting.
Scientific Assistant
Reference Standard Lab, United States Pharmacopeia
02.2007 - 04.2008
- Receive bulk reference standard material, verify all necessary documentation was received; and notify pertinent personnel of bulk status.
- Sample bulk reference standard material and distribute to internal and external testing facilities.
- Manage bulk reference standard material transactions using Oracle and other relevant databases.
- Liaised between departments to facilitate communication and keep appropriate parties updated on project developments and workflow.
Research Associate II
Sera Care Bio-Services
01.2005 - 01.2007
- Preparation of aliquots of Plasma, Serum, and Whole Blood with focus on accuracy and adherence to aseptic techniques. according to established Standard Operating Procedures (SOPs).
- Familiar with and assure compliance with Good Laboratory Procedures
- Maintenance of laboratory records concerning specimen receipt, Freezer Inventories, and experimental procedures
- Maintained ordering and stocking of laboratory.
- Complete all paperwork, Investigate, and resolve data discrepancies, and help with the prioritization of workload with other staff members.
- Performed duties in accordance with applicable standards, policies and regulatory guidelines to promote safe working environment.
Photo Lab Supervisor
Eckerd Pharmacy
01.2003 - 01.2005
- Ensures photo print quality is excellent, packages are complete, and orders are ready when promised
- Developed reputation for prompt, efficient service with high level of accuracy receiving top ratings from corporate office.
- Maintained customer satisfaction with forward-thinking strategies focused on addressing customer needs and resolving concerns.
- Supervised cashiers to boost customer service levels, check accurate balance for transactions, and promote smooth operations.
Substitute Teacher
Prince George County Public Schools,
01.2002 - 01.2005
- Followed classroom plans left by class teacher to continue student education and reinforce core concepts.
- Upheld classroom routines to support student environments and maintain consistent schedules.
- Kept students on-task with proactive behavior modification and positive reinforcement strategies.
Pharmacy Technician
Eckerd Pharmacy
01.2001 - 01.2003
- Solved customer problems in-person or over the telephone by providing assistance with placing orders, navigating systems and locating items.
- Communicated with prescribers to verify medication dosages, refill authorizations and patient information.
- Consulted with insurance company representatives to complete claims processing, resolve concerns and reconcile payments.
- Counted, measured, and compounded medications following standard procedures.
- Completed paperwork, entering prescription and insurance or billing information into patient profiles.
Administrative Assistant
Elizabeth City State University
01.1998 - 01.2000
- Performed a variety of clerical assignments that included, reviewing, logging, and distributing incoming correspondence
- Interacted with vendors, contractors and professional services personnel to receive orders, direct activities and communicate instructions.
- Filing, faxing, and coping.
- Answered multi-line phone system, routing calls, delivering messages to staff and greeting visitors.
Education
Masters in Business Administration -
University of Maryland Global Campus
2021
Bachelor of Science - Biology
Elizabeth City State University, II
2001
Skills
- Conduct studies of biological drug product reference standards for USP monographs and general chapters
- In depth knowledge of laboratory techniques, instrumentation, and analysis methods
- Project Collaboration
- Workflow Optimization
- Strong interpersonal skill
- Detail oriented
- Effective Communicator
- Knowledge of ISO 9001 and 17025 quality standards measurements
Affiliations
American Society for Microbiology (ASM)
Timeline
Scientist (Level II)
Biologics Laboratory, United States Pharmacopeia
08.2021 - Current
Scientist
Biologics Laboratory, United States Pharmacopeia
04.2014 - 08.2021
Associate Scientist
Biologics Laboratory, United States Pharmacopeia
04.2008 - 04.2014
Scientific Assistant
Reference Standard Lab, United States Pharmacopeia
02.2007 - 04.2008
Research Associate II
Sera Care Bio-Services
01.2005 - 01.2007
Photo Lab Supervisor
Eckerd Pharmacy
01.2003 - 01.2005
Substitute Teacher
Prince George County Public Schools,
01.2002 - 01.2005
Pharmacy Technician
Eckerd Pharmacy
01.2001 - 01.2003
Administrative Assistant
Elizabeth City State University
01.1998 - 01.2000
Masters in Business Administration -
University of Maryland Global Campus
Bachelor of Science - Biology
Elizabeth City State University, II
Similar Profiles
Sumesh SundaranSumesh Sundaran
Manager - Research Operations at United States PharmacopeiaManager - Research Operations at United States Pharmacopeia
C Vinod KumarC Vinod Kumar
Scientist IV at United States Pharmacopeia India Pvt. Ltd.Scientist IV at United States Pharmacopeia India Pvt. Ltd.
Jennifer CourseyJennifer Coursey
Chief, DNA Branch at United States Army Criminal Investigation Laboratory (USACIL)Chief, DNA Branch at United States Army Criminal Investigation Laboratory (USACIL)