Ross Kopher, Ms, Phd Email & Phone Number

Greater Minneapolis-St. Paul Area

Greater Minneapolis-St. Paul Area

Greater Minneapolis-St. Paul Area

Celcuity, Inc., a cellular analysis company, discovers cancer sub-types and commercializes live-cell diagnostic tests to enhance the response rates of cancer patients treated with targeted therapies in the United States. Celcuity develops CELx tests designed to discover new cancer sub-types andcommercializes diagnostic tests designed to significantly improve the clinical outcomes of cancer patients treated with these targeted therapies. CELx technology uses a patient’s living tumor cells to identify the specific abnormal cellular activity driving their cancer and the targeted therapy that can best treat it.RESPONSIBILITIES:• Development of Standard Work around the characterization and transfer of live-cell cancer in vitro diagnostic assays.• Co-developed reagent manufacturing Quality Control Processes and Procedures.• Generated testing plans for the execution of guard banding and lot-to-lot variability analysis of critical assay materials and reagents.• Led the development and execution of IQ/OQ/PQ activities of critical assay bioanalyzers.• Contributed to regulatory and FDA submission activities.• Developed and verified in-house liquid handler dispense and cell counting verification procedures.• Responsible for verification and validation activities.

Chaska, Mn

Lead development scientist for the technical transfer of newly automated molecular diagnostic assays. Familiar with drafting and editing standard operating procedures. Experience in developing experimental and characterization plans for guard-banding manufacturing capability and specification design.Experience in designing and characterizing calibration and controls plans for internal and external customers.Hands-on experience in reagent operations building pre-prototype and prototype lots.Familiar with identifying gaps in current processes and designing standard work documents for technical transfer activities.Completed Danaher Business System training in "Problem Solving Process" and "Training and Facilitation Techniques for Instructors".Contributed to Kaizen events, Value Stream Mapping and Process Flow presentations.

Stillwater, Mn

Product development of chemiluminescent clinical immunodiagnostic assays for the identification of microbial- and viral-derived infectious diseases. ACCOMPLISHMENTS:• Knowledge and understanding of immunology and immunoassay technology• Project management skills• Ability to present technical information in formal settings• Experience in Design of Experiments (DOE) methodology• Ability to design and interpret experiments appropriate to timely product development• Maintain appropriate documentation in compliance with QSR/ISO requirements• Ability to simultaneously manage team resources for multiple project tasks• Understanding and Experience in GLP/cGMP

Stillwater, Mn

Product development of chemiluminescent clinical immunodiagnostic assays for the identification of microbial- and viral-derived infectious diseases. ACCOMPLISHMENTS:•Lead Scientist on the development of 2 immunoassays successfully launched into the EU market.•Led/Contributed in the Design, Qualification and Validation of Six Assays/Products, including Troubleshooting Issues with Assay Performance.•Experience in Authoring SOPs, Protocols and Design/Validation Reports.•Experience in Leading Project Phase Reviews and Contributing to Core Team Meetings.•Maintained Quality Inter-Departmental Relationships to Ensure Smooth Progression of Product Development.•Certificate of Completion: Project Management and Chaos Theory.

Stillwater, Mn

Product development of chemiluminescent clinical immunodiagnostic assays for the identification of microbial-derived infectious diseases. ACCOMPLISHMENTS:Led/Assisted in the launch of 4 immunoassays/products.Trained in...- Immunoassay Design/Design Control- GLP/cGMP- Design of Experiment - Certificate of Completion: Experimental Design Made Easy- Process Validation and Verification- Antibody Conjugation- Manufacturing Principles and Process of Batch Builds- Quality Control- Master Batch Record Keeping

Minneapolis, Mn

FOCUS: Derivation and osteogenic differentiation of embryonic stem and induced pluripotent stem cell-derived mesenchymal stem cells.ACCOMPLISHMENTS:•Coordinated day to day activities with Primary Investigator (PI); performed in vitro and in vivo research experiments.•Wrote detailed IRB and IACUC animal experimental protocols.•Mentored both graduate and undergraduate junior scientists.•Kept daily notations on experiments performed, summarized and interpreted data, organized and wrote manuscripts for peer review.•Training in Principles of GLP/cGMP: SOPs, QC/QA, IV&V, Documentation, Hygiene, Manufacturing Operations, Master/Batch Records via OnAssignment Training.•Peer-Reviewer.

Minneapolis, Mn

FOCUS: Derivation and osteogenic differentiation of embryonic stem and induced pluripotent stem cell-derived mesenchymal stem cells.ACCOMPLISHMENTS:•Coordinated day to day activities with Primary Investigator (PI); performed in vitro and in vivo research experiments.•Wrote detailed IACUC animal experimental protocols.•Mentored both graduate and undergraduate junior scientists.•Kept daily notations on experiments performed, summarized and interpreted data, organized and wrote manuscripts for peer review.•Wrote DOD and NIH R01 grants in conjunction with PI.•Successfully Wrote and Awarded NIH R01 grant for supervisor. •Published peer-reviewed articles based on research•Awarded an NIH NRSA T32 Training Grant from the Minnesota Craniofacial Research Training Program at the School of Dentistry, University of Minnesota.•Awarded an NIH NRSA F32 Individual Postdoctoral Fellowship.

Chicago, Il

FOCUS: Functional use of mesenchymal stem cells coordinated with homing tendencies of hematopoietic stem cells and leukemic cells.ACCOMPLISHMENTS:•Coordinated day to day activities with PI; performed in vitro and in vivo research experiments.•Wrote detailed IACUC animal experimental protocols. •Kept daily notations on experiments performed, summarized and interpreted data.•Wrote a NIH NRSA T32 Training Grant within the Cancer Center, University of Chicago.

Chicago, Il

FOCUS: Employing mesenchymal stem cells in therapeutic techniques to improve osteogenic differentiation and bone tissue regeneration.ACCOMPLISHMENTS:•Coordinated day to day activities with PI; performed in vitro and in vivo research experiments. •Kept daily notations on experiments performed, summarized and interpreted data, organized and wrote manuscripts for peer review. •Several peer-reviewed articles published based on research.•Awarded the Odontographic Society of Chicago Award for Research in 2001, and the Outstanding Graduate Award from the Biomedical Engineering Society – UIC Chapter in 2003. Awarded numerous Travel Awards for research.

Master Of Science (Mspm) - 15 Of 36 Credits Completed, Project Management

Courses taken: Fundamentals of Project Management Project Planning and Scheduling Technical Communication Project Leadership Team.

Doctor Of Philosophy (Ph.D.), Bioengineering

Master Of Science (M.S.), Bioengineering

Bachelor Of Arts (B.A.), Biology