Key Responsibilities: Lead Product Hazard Assessment for Janssen Biologics, Lead workplace hazard communication/SDS process for Medical Device (MD), US Hazcom regulation Expert, Pharma and Medical Device TSCA Regulation Expert Leading workplace hazard communication and product safety assessment for Biologics, including mAbs, multi-specifics, conjugated proteins, cell therapy drugs, Bacteriophage, Conjugated Radiopharms, Protein Vaccines (including viral protein and bacterial protein)… Show more Key Responsibilities: Lead Product Hazard Assessment for Janssen Biologics, Lead workplace hazard communication/SDS process for Medical Device (MD), US Hazcom regulation Expert, Pharma and Medical Device TSCA Regulation Expert Leading workplace hazard communication and product safety assessment for Biologics, including mAbs, multi-specifics, conjugated proteins, cell therapy drugs, Bacteriophage, Conjugated Radiopharms, Protein Vaccines (including viral protein and bacterial protein), non-mAb recombinant Proteins, Plasmids, lipid Nanoparticle mRNA, Viral vaccines, and Bacterial vaccines; Partnering with scientific lead, Biosafety expert and IH to continuously deliver product safety classification and risk assessments for the whole Biotherapeutic portfolio by integrating toxicology, pharmacology, clinical and biosafety into the assessment process. Partnering with Biosafety and Radiation safety, developed cleaning and engineering controls for Biotherapeutics including mAbs, Cell and Gene Therapies (CGT), and Conjugated Radiopharms. Institutionalize (implement and train) product hazard communication processes (including both synthetics and biologiocs) into Janssen R&D, shipping, Trade Operation/Product Launch, DPDS, Global Clinical, Medical Information, and Customer Service Functioning as Biotherapeutic portfolio expert, introducing new product modalities to other product compliance experts.  Continuously Leverage Biotherapeutic product workplace safety knowledge across functions like OccTox, IH, REACH, Biosafety and R&D; First time brought biosafety assessment process into drug product Hazcom process for Janssen Biotherapeutics Major contributor in Biophorum (CGT) EHS platform, gave two presentations in the CGT conferences regarding hazard assessment for CGT compounds, and published a paper; Building a single access point for J&J product workplace safety; Show less

 Led Process and Product Investigations to ensure cardiovascular stent release at the Plant, and identified the root causes for the deviated QC results; Led multiple individual OTC drug customer complaint and counterfeit investigation projects, developed approaches to support marketing, and provided the technical reports for FDA filing; Established and maintained GMP quality compliance and Safety for the testing laboratories; Established and continuously introducing new… Show more  Led Process and Product Investigations to ensure cardiovascular stent release at the Plant, and identified the root causes for the deviated QC results; Led multiple individual OTC drug customer complaint and counterfeit investigation projects, developed approaches to support marketing, and provided the technical reports for FDA filing; Established and maintained GMP quality compliance and Safety for the testing laboratories; Established and continuously introducing new techniques or tools into the group to expand group capacities  Initiated, organized, and hosted a Corporate Analytical Symposium on Extractables and Leachables, which provided a unique collaboration opportunity for the company to determine a J&J benchmark for extractables and leachables; Member of the company Credo Action Team to identify improvement areas of the business management system, i.e. identification of additional collaboration, changes in the Strategy/Leadership and etc. Led process investigation projects for drug device cleaning process by providing insightful proposal and critical GLP validated analytical methods;  Led analytical projects for the Prosthesis Devices, developed various sample preparation and LC quantitation methods to allow quantitation of low level toxic drug components in a complex device coating matrix, and to address different impurity profiles for several different device subassemblies to support the device coating formulation development Show less