Lead Biotech Production Specialist III Resume Profile

RELEVANT WORK EXPERIENCE

cGMP Skills

SIP Steam-in-Place optimization
CIP Clean-in-Place optimization
SAT Site Acceptance Test test plan writing
FAT Factory Acceptance Test test plan writing
IOPQ test plan execution
VFD Variable Frequency Drive coding
RSLogix500 programmer
Ladder logic programmer
PID Proportional, Integral, Derivative Control tuning

Laboratory Skills

In vivo microdialysis and microinjection
Stereotaxic Surgery
Rodent behavioral testing
Immunohistocytochemistry
Histology
Western Blotting/ gel electrophoresis
NMR spectroscopy

Confidential

Lead Biotech Production Specialist III

Involved with a specialized team responsible for bringing a biopharmaceutical manufacturing plant up and running
Worked extensively on FAT, SAT test protocol execution to ensure all systems met compliance
Involved closely with Automation Engineers to ensure PLC Programmable Logic Controller worked according to specifications
Coordinated schedules with Process Engineers to ensure daily tasks were satisfied
Managed an elite team to ensure manufacturing plant was running according to an eight month schedule
Implemented BI's Biological Indicators and temperature mapping to optimize Steam Sterilization
Mapped out Process Flow diagrams for optimization of CIP procedures
Assisted in the coding of VFD's for vessel pumps, and agitators
Tuned PID control loops for pumps, agitators, temperature regulators, and process gases
Executed IOPQ test plan for bioreactors and various other pieces of equipment
Involved in the electrical wiring of Class1, Div1/ Class1, Div2 rooms
Reviews, edits, and revises completed batch records, logbooks, and SOP's in accordance with cGMP standards and compliant with written procedure
Performs in process sampling, quality control chemistry and quality control microbiology
Assists with training of new employees
Gathers, trends, and analyzes process generated data
Responsible for all aspects of biotech production activities related to cell culture
Ensures system operational readiness
Ensures availability of production batch records for upcoming lots
Assist with troubleshooting in case of equipment failure

Confidential

Research Assistant

Worked extensively on various projects under the Alzheimer's Association Research Grant and NIH grant
Worked with a mentor in order to complete research goals
Proficient in many lab techniques and can use various machinery located in a lab setting e.g. centrifuge, magnetic stirrer
Coordinated with other labs using NMR Spectroscopy
Managed research teams
Second author on several papers currently being reviewed
Oversaw and completed projects independently
Responsible for the maintenance and upkeep of the laboratory's website
Ran statistical diagnostics using Microsoft Excel and SPSS on ongoing projects

Confidential

Teacher

Developed and implemented curriculums
Assured the security and protection of children ranging from the ages of 6 months- 5 years
Met with parents regularly regarding children's needs and progress
Participated in extracurricular activities such as sports, arts, and crafts

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