Melanie Schafer
Jim Thorpe,PA
Summary
Dedicated individual with skills and experience in Cell Culture, Microbiology, and qPCR. Motivated multitasker with excellent communication and problem-solving skills.
Overview
13
13
years of professional experience
Work History
Paraprofessional Aide
Jim Thorpe School District
Jim Thorpe, United States
01.2016 - Current
- Delivered personalized educational support to individual students to enable positive learning outcomes.
- Organized and oversaw Family Math and Reading Nights.
- Instructed small groups of students in basic concepts such as alphabet, shapes and color recognition.
- Implemented practice exercises and used repetition, enabling students to grasp new concepts quickly.
- Worked one on one with students on specific skills.
- Oversaw students in classroom, enforce rules and support lead teacher.
- Organized and guided skills practice, research and memorization tasks for students.
Research Technician II
Sanofi Pasteur
09.2005 - 01.2007
- Conducted serologic assays of human clinical trial sera including qPCR
- Extracted nucleic acids from cells and viruses
- Performed validation studies on equipment and procedures
- Recorded data in lab notebooks and/or data sheets
- Provided oral summaries to staff
- Performed scheduled maintenance on equipment
- In charge of scheduling personnel in labs
Associate Scientist I
Medarex inc
05.2005 - 09.2005
- All responsibilities listed for Assistant Scientist II in addition to:
- Prepare presentations, Technical, Development, and non-conformance reports
- Ensure GMP activities are in compliance with SOPs and Batch Records
- Generation and revision of SOP documents for use in preparation of Master Cell Banks and Manufacturer’s Working Cell Banks under cGMP conditions
- Responsible for reviewing outside characterization testing and communication with QA
- Prioritized project tasks after discussions with Cell Culture department team
- Trained newly hired employees on processes and procedures relevant to lab tasks at hand.
Assistant Scientist II
Medarex inc
05.2003 - 05.2005
- All responsibilities listed for Assistant Scientist II in addition to:
- Aid with all GMP activities pertaining to Master Cell Banks and Manufacturer’s Working Cell Banks
- Assist in scheduling calibration and validation of GMP equipment
- Evaluation of diverse animal component-free media on various cell lines
- Responsible for independently preparing Master Cell Banks and Working Manufacturing Cell Banks under cGMP conditions
- Amplification of DHFR/MTX cell line in 5L bioreactor
- Assist in thepreparation of audits and resolve any issues that arise.
Assistant Scientist I
Medarex inc
05.2001 - 05.2003
- Development of Hybridoma and Transfectoma cell lines genetically engineered to produce human monoclonal antibodies
- Extensive sub-cloning via limiting dilution of cells in both serum-free and protein-free media for isolation and selection of stable and high antibody expressing strains
- Characterization of isolated monoclonal cell lines for growth and antibody productivity, stability, and testing for adventitious agents
- Cell lines included AP20, Ag653, and CHO
- Cell culture vessels included T-flasks, shaker flasks, and spinner flasks
- Assist in preparation of Master Cell banks and Manufacturer’s Working Cell Banks under cGMP guidelines
- Perform DNA transfection
- Daily monitoring of GMP equipment including Liquid Nitrogen Cryofreezers, Incubators, Refrigerators/Freezers, Dewars, and Room Pressure
- Responsible for preparing, shipping, and tracking cell line development test samples
- Order supplies for the department using Workplace electronic purchasing system
- Training in cGMP, safety, and Qumas
- Perform ELISA and Neph assays for antibody quantitation
- Maintain laboratories for the group by stocking inventory, ordering new equipment, and assuring labs run in an orderly manner
- Maintenance and sampling of 5L batch, fed-batch, and perfusion bioreactors.
Microbiologist
Binney & Smith, Manpower
12.2000 - 05.2001
- Performed sterility and preservation testing on products
- Executed bacterial and fungal challenge testing to confirm preservative’s efficiency
- Identified bacterial and fungal colonies in samples using Enterotube and Oxiferm
- Responsible for maintenance of cultures
- Compiled data for reports.
Research Assistant
Aventis Pasteur, Manpower
05.2000 - 12.2000
- Led research project on Influenza virus in order to improve manufacturing process
- Performed Diafiltration, Column Chromatography, and TFF
- Assisted in MSTA project, inoculated chicken eggs, harvested embryonic fluid, ran ELISA, Hemagglutination, and CFU assays
- Executed sterility testing by bacterial plate counts
- Responsible for ordering raw materials ad reagents on SAP system.
Education
Bachelor of Arts - Biology
Cedar Crest College
Allentown, PA05.2000
Associate of Arts - Business Administration
Northampton Community College
Bethlehem, PA05.2000
Skills
- Trained in cGMP, experience in cGMP environment
- Experience in writing and editing detailed reports, SOPs
- Aseptic mammalian cell culture techniques include: passaging, subcloning, freezing/thawing, and preparing cell banks
- Proficient Microbiology techniques and procedures
- Trained in QC assays: qPCR, ELISA, RIA, Southern Blot Analysis
- Proven ability in analysis, scientific theories, and procedures
- Analytical skills, knowledge of scientific methods and research perspectives
- Competent in collecting and analyzing data
- Proficient in Excel, Word, PowerPoint, Google Docs and internet applications
- Excellent communication, assessment, and data presentation skills
Timeline
Paraprofessional Aide
Jim Thorpe School District
01.2016 - Current
Research Technician II
Sanofi Pasteur
09.2005 - 01.2007
Associate Scientist I
Medarex inc
05.2005 - 09.2005
Assistant Scientist II
Medarex inc
05.2003 - 05.2005
Assistant Scientist I
Medarex inc
05.2001 - 05.2003
Microbiologist
Binney & Smith, Manpower
12.2000 - 05.2001
Research Assistant
Aventis Pasteur, Manpower
05.2000 - 12.2000
Bachelor of Arts - Biology
Cedar Crest College
Associate of Arts - Business Administration
Northampton Community College
Similar Profiles
Ava TrineAva Trine
Junior High Head Cheerleading Coach at Jim Thorpe Area School DistrictJunior High Head Cheerleading Coach at Jim Thorpe Area School District
Amanda MontoyaAmanda Montoya
Student Teacher at Jim Thorpe Fundamental, Kindergarten And 1st GradeStudent Teacher at Jim Thorpe Fundamental, Kindergarten And 1st Grade
Mary E. CashMary E. Cash
Special Education Teacher at Jim Thorpe AcademySpecial Education Teacher at Jim Thorpe Academy