Daniel Ropp Email & Phone Number

Irvine, California, Us

Irvine, California, Us

San Diego, Ca, Us

Lawrence Township, Nj, Us

Summit, New Jersey, Us

Design the qualification approach and provide the scientific rationale and acceptance criteria, generate validation protocols and assist other department members in conducting industry and regulatory research.Subject Matter Expert for Lyophilization process, Airflow Visualization (smoke) studies, and Room QualificationProject Manager for new dosage form that was transferred to the facility ($2 million budget)Operate instrumentation, execute protocols, and perform validation activities.Perform complex data analysis (including statistical probability) and prepare written reports/summaries from validation studies. Write/approve validation protocols.Prepare project schedules and update department management on timelines.Coordinate with applicable departments to ensure project activities are completed as scheduled.Calibrate or verify calibration of critical process instrumentation and equipment and prepare documentation of the calibrations related to validation requirements in protocols.Serve as a Validation representative for various project teams.Participate and defend validation approaches in regulatory audits.Process change controls and perform validation non-conformance investigations.Conduct training on protocols associated with newly validated equipment, systems, processes, and specifications when transferring them to responsible operating group.Write, review, and revise SOPs.Interact and collaborate with departments (on and offsite) as well as vendors, consultants, and other external service providers.

Los Angeles, Ca, Us

Developed and directed implementation of new scale up processes, new equipment and procedures, process validation, manufacture of stability and validation batches.Assisted in validation work required to start up a new manufacturing facility.Study Director for clinical and stability batch manufacturing protocols, product validation protocols and final reports.Project Manager for cross-functional team tasked with transferring a new product to the facility.Identified and implemented process improvements designed to enhance product quality; conducted product transfer scale-up evaluation and support.Coordinated plant documentation needed for CMC section of product submissions.Provided technical assessment of changes in manufacturing through appropriate review of documentation and testing/trial results.Lead groups of people that do not have reporting relationships.Evaluated and implement global manufacturing requirements.

Responsible for ensuring that the chemical integrity is not compromised during scale-up from lab scale to commercial productionWrote protocols and reports for process validations, process evaluations, stability production, clinical production, and formulation studiesEnsured that these protocols were executed properly by traveling to the plant and observing all phases of production, including testingResolved issues that arose during the productions in order to ensure that the product is produced correctlyLiason between the plants and R&D in order to answer questions and coordinate productionsDeveloped studies in order to maximize production efficiency and/or to resolve problems during scale-upAssisted in producing batches in the Pilot PlantAttended cross function team meetings, including with external customers, as the Pharmaceutical Technology representative to ensure all project timelines are metTrained new employeesGave technical presentations

In charge of stability for pharmacy admixture serviceAuthor of stability protocols and final reports to establish dating for all products offeredMember of the start-up team for the narcotics facility in Cleveland, MSExperienced with software, equipment, and facility validationsInteracted with various groups, including working with and coordinating testing with outside contract labsKnowledge of requirements of various regulatory agencies, including FDA and DEA

Non-Cephlasporin Chemistry Lab Supervisor responsible for all aspects of a three shift QM labResponsible for making sure that the lab is staffed and able to meet manufacturing needsResponsible for ensuring that all testing is completed and product and raw materials are released on timeGave multiple written and oral presentationsStudy director for all studies for the Non-Cephlasporin Chemistry LabLeader of the Formulation PMT and IQ OQ PQ QWT

QM Chemist responsible for testing of all IV drugs producedProficient in the use of HPLC systems, UV spectrophotometer, osmometer, autoturb, and various other equipment used in a chemistry labMember of TEI Committee, Purge Validation Team, and First Pass Yield Core TeamWorked on many projects, including assay transfers and new product validations

Technician II in FDA and OSHA regulated plasma screening labResponsible for viral marker testing for HB, HC, and HIVExperienced in the use of automated and manual pipettors, enzyme immunoassay automated test processor, incubator, and autoclaveTrained new employees in all proper lab procedures

at OSHA regulated toxic waste laboratoryResponsible for various tests in the inorganic sectionExperienced in dilution s, distillation, fractionation, and titration

B.S. Degree, Biology

Education record