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Sr. Specialist Resume Example

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SR. SPECIALIST
Professional Summary

Multi-talented Sr. Scientist and Certified Project Manager with a quality-driven and disciplined approach to completing Regulatory Submissions. Decisive leader, strategic planner and complex problem-solver with 15 years of Pharmaceutical experience. Pursuing new professional challenges with a growth-oriented company.

Skills
  • Collaborator
  • Cross-Functional Team Member
  • Facilitate Planning/Strategy Meetings
  • Process development
  • Detail-oriented
  • Planning and Coordination
  • Interpersonal Communication
  • Organization and Time management
  • Project Management
Work History
Sr. Specialist, 10/2016 to Current
Company Name – City, State
  • Experienced Certified Project Manager (CPM) with substantial experience in Submission planning, reporting and execution in pharmaceutical global regulatory affairs. Solid knowledge and understanding of the EU and US drug development and approval processes.
  • Regulatory Project Manager that collaborated with cross-functional contributors to collect and/or prepare submission information for IND, CTA, BLA, Orphan Drugs, Pediatric , supplements, post approval commitments, schedule compliance reports and responses to requests for information from regulatory agencies worldwide relating to both investigational and marketed products.
  • Current project therapeutic area resides in the Oncology portfolio including KEYTRUDA® (pembrolizumab).
  • Build and drive regulatory cross- functional teams focused on the identification, planning, and execution of Oncology regulatory submissions (including combinations), with an end-to-end mindset.
  • Facilitate meetings effectively and clearly communicate decisions and action items to team members and relevant parties outside of the team.
  • Identify, assess and actively resolve or escalate where necessary any risks or issues that could impact the successful completion of submissions.
  • Actively manage timelines including a clear understanding of dependencies and critical path.
  • Ensure project data (including information used to maintain compliance and aid with submissions planning) is accurately reported in databases andunderstood by stakeholders.
  • Proactively drive project teams, establish appropriate level of urgency, and maintain focus on deliverables.
Scientist, 04/2008 to 09/2016
Company Name – City, State
  • Experienced Scientist in cGMP and/or GLP laboratory environments. Lab analysis included both manual and automated Biochemical and ELISA assays for Vaccine product development.
  • Skilled with automated instrumentation which included the Tecan Liquid Handlers and the HP D300 liquid dispensers along with review of new technologies.
  • Supervise/coordinate laboratory activities to meet on-demand testing for process and formulation development to support current portfolio
  • Support MMD Production with in-line product testing as needed
  • Implement new assays/technologies from for routine process monitoring support.
  • CRM Capture ELISA: Supported adjuvant syringe stability to support TOR for PhI/b clinical study; adjuvant vial stability to support SA and FIH; characterization stability of PhI/b clinical lots; final timepoints of original vial stability study with Poloxamer188;
  • Completeness of Adsorption: Support adjuvanted syringe stability to support TOR for PhI/b clinical study [MSD]; adjuvanted vial stability to support SA for FIH [MSD]; characterization stability of PhI/b clinical lots [CRM Capture COA]; final timepoints of PhII characterization stability and original vial stability study with Poloxamer188 [MSD]; perform studies to cross-over COA from MSD assay to CRM Capture ELISA
  • MSD Completeness of Adsorption: Support PhI/II characterization stability and long-term stability studies for adjuvanted formulation development.
  • Provide assay support for process monitoring and characterization data for MRL and MMD using the Tecan Robotic Workstation.
  • Release and Stability Testing for V114 MSD CoA mass elisa assay and V114 CRM Capture Mass Elisa.
  • LAL, Picogreen, BCA, Polysorbate-80, Benzonase, IGEN, Host Cell Protein, IVRP and EC-50/IC-50.
  • Maintain full compliance with GMPs, and and ensure highest quality of data and documentation.
  • Contribute to assay optimization and troubleshooting and sample qualification.
Biologist, 11/2004 to 01/2008
Company Name – City, State
  • Manual 15 serotype Total Polysaccharide Elisa testing for formulation support and assay optimization.
  • Optimization of Total Poly Assay using new antibody pairs.
  • D300 Robustness and Accurracy Precision testing for current and next generation Elisa
  • Maintain Reagent/Assay Ab Inventory.
  • Lab equipment coordinator for repairs and PM's.
  • Optimize existing Tecan automated liquid handling scripts for 15 serotype Total Polysaccharide Elisa assay.
Professsional Medical Technologist, 05/1992 to 08/2004
Company Name – City, State

Worked in various manual and automated labs in Chemistry, Hematology, Blood Bank, Endocrinology and Toxicology Clinical Labs.

  • Trained and oriented new medical technologists to perform and interpret tests.
  • Managed routine laboratory operations and supervised employees.
  • Followed laboratory protocols for specimen processing, analysis and results reporting.
  • Prepared blood, plasma, and platelets for transfusions by conducting blood group, type and compatibility tests.
  • Evaluated quality control within laboratory using standard laboratory test and measurement controls.
  • Operated, calibrated and maintained sophisticated instruments and equipment to facilitate quality laboratory and patient care operations.
  • Completed specimen collection and analysis while complying with OSHA, Universal Precautions and quality assurance policies.
  • Employed microscopic techniques to collect and study blood samples to determine number of cells, morphology and blood group, assessing compatibility for transfusion purposes.
  • Operated Coulter's, Hitachi and Kodak laboratory equipment, and adhered to strict maintenance schedules.
Education
Bachelor of Science: Medical TechnologyThomas Jefferson University
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Resume Overview

School Attended

  • Thomas Jefferson University

Job Titles Held:

  • Sr. Specialist
  • Scientist
  • Biologist
  • Professsional Medical Technologist

Degrees

  • Bachelor of Science : Medical Technology

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