John Wrobleski Email & Phone Number

Frederick, Md, Us

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 using high resolution melt (HRM). Other notable responsibilities and accomplishments included:• 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.• Completed 4 shipping studies, including domestic and international shipments, allowing ambient shipping of all Novallele™ reagents.• Co-authored white paper about Novallele™ reagent ambient shipments, discussing shipping study results, and outlining the benefits to customers and the planet. • Designed and set-up new quality control lab spaces after new construction.• Completed secondary vendor qualification studies for raw materials.• Completed studies on Novallele™ Mastermix which supported new packaging and raw material testing to create a more stable product.• Completed 94 Out Of Specification (OOS) investigations.• Trained new personnel on company policies, QC testing, and procedures. • Nominated by manager to complete Management Essentials course at Canon USA headquarters.• Owned and executed testing schedule, providing quick turn-around times.

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 trained with the cell culture group. Primary backup to QC supervisor as representative for planning meetings and nonconformance reviews. Led QC team meetings.

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 after the Camarillo transfer, answering auditor questions, especially concerning the HER2 CISH kit. The site passed the audit with no problems or issues, allowing the Frederick site to continue manufacturing and testing as a highly regulated site.

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 pharmaceuticals.

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.