Experience

Frontera Therapeutics

• United States
• Biotechnology Research
• 1 - 100 Employee

• Laboratory Manager/Facility Manager/Interim Office Manager

  • Aug 2021 - Present



Resilience

• United States
• Biotechnology Research
• 700 & Above Employee

• Interim Laboratory Manager

  • May 2021 - Present



AbbVie

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• QA Specialist

  • Jul 2018 - Present

  Managed stability studies in LIMS for ABC. Modified the specification of the stability studies in LIMS as new version of governing documents are created. Resolved any issues that were flagged by the data reviewers in LIMS. Spearheaded the migration of data from earlier version of LIMS to current version meets the GMP data integrity. Executed the login ad hoc samples to LIMS. Coordinated requester with QCA & QCM personnel when issues arise with ad hoc samples. Generated SRI reports as needed. Compiled initial data for Six Sigma initiative. Led implementation of inventory management system from ELN to LIMS. Resolved issues arise on QA System with team members; Sought out colleagues from Global if necessary. Initiated & completed training on SAP for QA Administrator. Accomplished logistical duties with Incoming QA & Solution Record documents while a colleague was on leave. Executed logistic duties on Maximo once Work Orders are completed. Trained as Record Coordinator QCA & QCM archiving in Records Information Management System (RIMS). Adhered to GxP training courses in Isotrain



4 Squares Consulting

• Greater Boston Area

• Principal

  • Aug 2015 - Present

  Oversee project management and R&D as an independent DMPK and Bioanalytical consultant for QSC, Inc. Clinical Auditor (QSC, Inc.) · Verified clinical site source data was in alignment with the electric data. Enhanced quality assurance (Q&A) by manual inspection and tracked all deviations, ensuring that files complied with GCP and FDA regulation. · Examined MS clinical data for Phase 3 with facility surveillance conducted by the FDA. Slashed time used in computing numbers of days between visitations 50% by developing a MS Excel macro file. Confirmed all specifications and finalized approvals from the IRB and IEC. · Safeguarded pharmacovigilance for Q&A including negative events or drug reactions. Certified that consent forms were accurately signed and dated with authorized interpretation. Oversaw the signing of translated forms and the final verification of the person undergoing the clinical trial. Senior Quality Consultant (QSC, Inc.) · Supported DMPK projects sponsored by the client. Evaluated scientific data, supporting documentation, files, conclusions in conformity with regulative protocols, and enforced adherence to all procedures. Assisted the sponsoring firm in determining if the data deemed non-compliance was usable for submission to FDA, thus avoiding time delay slashing millions of costs and expenditures and avoiding repeating costly clinical trials such as in Phase 1, 2, and 3. · Led the groundwork of remediation paperwork like reports, amendments, response-only, note-to-files, deviations, and examining observations. Liaised with internal units regarding a plan to assist DMPK submission and development for GLP and Non-GLP clinical research. · Performed scientific observations internally (CAPAs). Remediated clinical and non-clinical Bioanalytical research and reported substantiations against SPO, direction, and GLP. Expedited regulatory data adjustments.



AstraZeneca

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Associate Scientist, Discovery Science-Center of Excellence in Enzymology

  • Apr 2011 - Sep 2013

• Treasurer of Social Activity Club

  • Aug 2002 - Sep 2013

• Core Committe Officer

  • Aug 2002 - Sep 2013

• Senior Associate Scientist - Drug Metabolism Pharmacokinetics (DMPK)

  • Sep 2006 - Mar 2011

• Associate Scientist - Drug Metabolism Pharmacokinetics (DMPK)

  • Jul 2002 - Sep 2006

• Safety Officer - Drug Metabolism Pharmacokinetics (DMPK)

  • Jul 2005 - Jul 2006



Neurogen Corporation

• Biotechnology Research
• 1 - 100 Employee

• Research Associate II

  • Jul 1998 - Jul 2002