John Kronberg Email & Phone Number

Boston, Ma, Us

Framingham, Ma, Us

Cambridge, Massachusetts, Us

Cambridge, Massachusetts, Us

o Perform, and drive in-depth laboratory investigations to completion. Determine root cause and propose appropriate CAPAs. o As assigned, perform complex laboratory testing—reserved for senior level analysts-- to support raw material, in-process, finished product and stability sample release.o Provide SME support for electronic QC database systems and laboratory data integrity compliance (Empower, Nugenesis, SampTrak) to support the QC laboratories.o Lead administrator for training and Empower Chromatographic System, and back-up administrator for Nugenesis LMSo Provide support for instrument troubleshooting, instrument repair, and instrument calibrations for the QC laboratories.o Serve as a Qualified Scientist when needed by performing an in-depth technical review of all analytical and microbiological testing performed on finished products – in-process samples, stability samples, raw material samples, and environmental samples, ensuring compliance with GMPs.o Assist laboratory management as a mentor in the development of all levels of analysts in the laboratory. This mentorship includes technical guidance regarding GMP fundamentals, chromatographic/spectrographic systems, and general analytical testing.o Provide laboratory information and documentation requests to site management and CM customers required for regulatory filings and product import/export needs, when requiredo Review product trends and identify out-of-trend resultso Assess method reliability and trend data for inclusion in PQR/APRo Revise and improve analytical methods, protocols, and associated SOPso Participate in and adequately represent the QC laboratories in customer and regulatory audits of the facility.o Manage the transfer of RDM methods into the QC laboratory for early phase products. Work with QC and QA to ensure success of these transfers.o Participate in and lead projects for continuous improvements in methods or method execution.

o Supervision, training, and coaching of Analytical Laboratory staff • Have been responsible for the direct supervision upwards of ten analysts covering two shifts. This has required being on-call after routine hours to assist 2nd shift as needed.• Mentoring analysts to assist career/personal development and implementing strategic steps to achieve goals has been a priority.o Assure operations in the lab are in compliance with cGMPs and Company SOPs/policies.• Have taken part in multiple Government and client audits. No critical findings for QC Chemistry during my tenure.o Named Interim Manager for QC Chemistry on multiple occasions during tenure• Due to high turn-over rate of Manager role. Transition period during each instance was successful, with the lab continuing to have successful audits and deadlines routinely being met for sample delivery.o Responsible for the analytical testing and scheduling of finished product, raw material, stability, engineering, and in-process material samples. o Review and approval of analytical test data coming from QC Chemistry Laboratoryo EHS Emergency Coordinatoro Communication of analytical operational issues to affected departments across the facility.o Lead numerous high-profile non-conformance deviation and OOS investigations within the laboratory autonomously.o Streamlined and help implement multiple systems within the QC laboratory to improve efficiency and traceability. This includes the reference standard program, general usage of the Empower Chromatographic system, and the new NuGenesis Laboratory Notebook program.

Lancaster, Pa, Us

* HPLC Analysis* Dissolution (Apparatus I & II)* Gained experience with Automation Platforms, specifically dissolution and potency analysis* Training with Near Infrared analysis* Experience with method development and validations/qualifications* GMP documentation in both development and clinical supply mode laboratories* Performance reviews* Career development of direct reports* Lead Trainer for new hires in local building. Training administered includes HPLC, Dissolution, Verification, and electronic notebook usage.* Subject Matter Expert in electronic notebook software* Workload management--Communicating with project leads regarding incoming samples. Act as lead liason between Lancaster group and the client. Assign testing to lab analysts.* Document review and data integrity* LIMS entry* Named as Local IT representative. Designed workflow to allow employees to notify me regarding various software/hardware problems. Acted as "middle-man" before contacting Corporate IT directly.

Lancaster, Pa, Us

* Electronic Notebook Subject Matter Expert (SME)* Focus on cross-training lab personnel to grow individual skill sets and allow group to branch into other areas* Lead Dissolution and HPLC trainer* Lead verifier of completed data packets* Experience with LIMS entry* Workload management--Communicating with project leads regarding incoming samples. Act as lead liason between Lancaster group and the client. Assign testing to lab analysts.* Conduct Performance reviews of direct reports and assist in their desire to grow in specific fields of expertise.

Lancaster, Pa, Us

* Took part in Method Development and Optimization* Undertook role of developing implementation of electronic notebook documentation for GMP lab use* Analyzed stability samples following complex methods* Named lead trainer for HPLC, Dissolution, and electronic notebook software* Coordinated local reference standard use in laboratory* Undertook verification of completed data packets

Lancaster, Pa, Us

* Routine stability sample analysis in a GMP environment* Samples analyzed via HPLC.* Dissolution

West Lafayette, In, Us

GMP/GLP compliant laboratory