John Wrobleski Email & Phone Number

Frederick, MD, US

Bergisch Gladbach, North Rhine-Westphalia, DE

QC Supervisor for the Analytical QC Cell Gene Therapy group with Miltenyi Biotec in Gaithersburg Maryland.

Rockville, MD, US

Responsible for quality control analysis in the QC Potency group focusing on ELISA and Bioassay testing. Release, stability, qualification and validation testing performed.

Responsible for the review of analytical records generated during the testing of vaccines for compliance to current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs). Records included: lot release test records, stability test records, raw material test records.

• Primarily responsible for leading the Quality Control team, and for the development, implementation and execution of raw material and finished good QC testing. Canon BioMedical, Inc. focused on PCR genotyping assays.
• Managed QC personnel with direct report and delegation responsibility.
• Transferred over 700 products from R&D to Operations, which included: setting product specifications, creating documentation and training on new testing techniques.
• Wrote procedures, work instructions and forms in compliance with quality standards and cGMP, ISO 13485:2016, and 21 CFR Part 820 regulations.
• Completed 3 real time stability studies. Responsible for stability testing, tracking and reporting for all Canon BioMedical, Inc. reagent families.
• Established ongoing monthly stability testing program for Novallele™ products by creating procedures, selecting reagents, and tracking results.

Waltham, MA, US

Primarily responsible for raw material, intermediate, complaint, and final quality control testing of immunohistochemical (IHC) and chromogenic in situ hybridization (CISH) detection system reagents, many of which were IVD. Independently determined reagent disposition for all IHC/CISH reagents based on QC results. Performed qPCR, HPLC, Mass Spec and.

Waltham, MA, US

Primarily responsible for raw material, intermediate, complaint, and final quality control testing of IHC and CISH reagents. The primary employee responsible for transfer of IHC/CISH QC testing from Camarillo CA to Frederick MD, including extensive verification testing for the HER2 CISH kit, a Class 2 medical device. Played a key role in the FDA audit.

Glostrup, DK

Primarily responsible for the manufacture and in-process quality testing of immunohistochemical and in situ hybridization detection system reagents, prediluted antibodies and ancillary products. Many of the products manufactured and tested were IVD kits, including some PharmDx™ products which were diagnostic kits tied to treatment with specific.

Eatonton, Georgia, US

Primarily responsible for the purification of human enzymes for either direct sales or use in products, such as controls and calibrators for diagnostic instruments.