Professional Summary

Highly motivated individual with a demonstrated history of working in laboratory and pharmaceutical manufacturing environments for the global leader in nuclear medicine. Experienced in the handling and production of radiopharmaceuticals. Successfully participated in the development of PET agent (Detectnet) from project development to market. Education

BS in Biological Sciences with an Emphasis in Cellular and Molecular Biology Lindenwood University, St. Charles, Missouri

2013 – 2017

Graduated Summa Cum Laude (3.96 GPA) in December 2017 Notable Skills

• Aseptic Laboratory Techniques

• Pharmaceutical Manufacturing

• General Lab Techniques (GLP)

• Microbiology Techniques: genus/species identification, subcultures, streaking, staining, and anaerobic incubation

• Quality Control (Notably the Development of Control Systems)

• Environmental Monitoring (EMPQ)

• Controlled Document Handling

• Training Colleagues in Production/Quality and Compliance Notable Experience

• Redline Reviews for SOPs, batch records, and training protocols

• Aseptic Filling of Pharmaceuticals

• Process Validation Runs (Media Fills): media reads following incubation, media fills from prep to dispense, PVR documentation

• Development of planned interventions and aseptic practices for media fills

• EMPQ's for a cGMP Room

• Pharmaceutical Grades A, B, C, and D

• Training colleagues in quality practices from testing to controlled document reviews

• Training colleagues in production activities including gowning, solution prep, formulation, dispensing, disinfection, and packaging

David Adams

St. Louis, Missouri

adh8yr@r.postjobfree.com

573-***-****

Notable Training

• LIMS

• MIMS/Siemens

• Environmental Investigations

• Root Cause Analysis

• Risk Assessment

• Change Controls

• TrackWise (QTS)

• Purchase Orders

• 5S Workplace Organization

• Teams

• Office 365

Work Experience

Manufacturing Eng Tech III

Curium Pharma

January 20 – Present

• One of original technicians responsible for transition of Detectnet™ from project to stable product

• Active participant for the EMPQ of lab

• Assist with updates to SOPs and batch records to ensure that they accurately depict the process as it develops

• Participate in RCA's and investigations

• Responsible for training new members of the team in gowning, VHP, material entry, EM, and dispense

• Strong contributing factor of 5S implementation in lab as well as creator of an up-to-date ordering system for components

• Adjusted storage conditions within the lab and warehouse to increase storage capacity for the department

Environmental Monitoring Quality Tech II

Curium Pharma

July 18 - January 20

• Responsible for monitoring environmental conditions of multiple production labs to ensure compliance with FDA/NRC guidelines

• Personal duties included sampling of each lab, data analysis of the acquired information, general lab upkeep, and analysis of current regulations to ensure adherence to cGMP regulations

• Notable projects include revising the metrics for contamination levels throughout each lab and updating documents for contamination control team

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