Summary
Overview
Work History
Education
Skills
Certification
LinkedIn
Technology
Timeline
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ALVIN BREWSTER

ALVIN BREWSTER

Lynn,MA

Summary

In my current position I have various roles within Pre-Clinical, Clinical, and Manufacturing. I manage a variety of regulated (GxP) projects ranging from implementation of commercial off-the-shelf technologies, to supporting, upgrading, and enhancing various systems. In partnership with various business stakeholders, I develop, design, implement and support technology solutions. Additionally, I partner with business leadership to build and deliver capabilities and execute on roadmaps that align to support Vertex's business strategy.

A grit-based, emotionally intelligent professional offering 13 years of experience in Biotech.

10 years of experience in project management, business analysis, and process optimization in a cross functional and regulated environment.

Overview

13
13
years of professional experience
1
1
Certification

Work History

Business Engagement & Technology Principal Analyst

Vertex Pharmaceuticals
Boston, MA
07.2021 - Current

I serve as the IT focal point for Pre-Clinical, Clinical, and Manufacturing as IT Business Analyst/IT Project Manager, Validation Lead, and Product Owner to various systems.

Notable Achievements

  • Optimized Vertex’s validation processes and procedures by spearheading the implementation of CSV (Computer Systems Validation). As a result, reduced the time and effort required for validation activities by a significant amount.
  • Communicated with varying organizational levels to build consensus on the implementation of a paperless validation system; greatly increasing Vertex’s system validation capabilities and efficiency.
  • Spearheaded initiative to optimize standard operating procedures to include a process for the electronic signing of validation documentation.

Business Engagement & Technology Senior Analyst II

Vertex Pharmaceuticals
Boston, MA
12.2018 - 07.2021

I serve as the IT focal point for Pre-Clinical, Clinical, and Manufacturing as IT Business Analyst/IT Project Manager, and Validation Lead

Notable Achievements

  • Significantly increased the company’s ability to optimize manufacturing efficiency and future revenue earning potential; as a result of spearheading the implementation of an archiving and reporting system for the Development Launch Rig (DLR) and Process Analytical Technology (PAT) lab data generated using the Synchronized Total Quality (SynTQ) application – received Gold VOCAP award for accomplishment.
  • Improved the efficiency of performing statistical analysis and data sharing on study data within Analytical Development by devising the validation strategy for updating the Stability Laboratory Information Management (SLIM) system, which translates to an increase in future revenue potential – earned Gold VOCAP award for accomplishment.
  • Promoted to Business Engagement & Technology Principal Analyst.

IT Business Analyst

Biogen
Cambridge, MA
01.2014 - 02.2018

I served as the IT focal point for Human Resources, Finance, Marketing, and Pre-Clinical as IT Business Analyst/IT Project Manager and supporting daily system activities.

Notable Achievements

  • Revived and spearheaded the company’s previously failed attempt to merge two on-prem learning management systems into the SuccessFactors Learning Management System and saved the company upwards of $2,000,000 in licensing and contract costs, in addition to $800,000 in enhancement costs – earned a Biogen Great (BIG) award for achievement.
  • Enhanced the process of retrieving GxP training records from SuccessFactors Learning Management System by implementing Salesforce Shield and DocuSign 21 CFR Part 11 to close several compliance gaps in the procedure, potentially saving the company money in fines ranging between $50,000 to $1,000,000 – received Biogen Great (BIG) award for achievement.
  • Aided in the implementation of integration between HubSpot for marketing automation and Salesforce (CRM) increasing potential company revenue – received Biogen Great (BIG) award for achievement.

Security Officer / Security Systems Coordinator / Site Supervisor

Biogen, Securitas Security Services
Cambridge, MA
10.2010 - 01.2014

I Functioned as a supervisor of Security Officers, Lead Officers, and other company personnel assigned to one or more posts at client site(s). Additionally, I functioned as the System Coordinator; responsible for access controls and management of all security systems.

Notable Achievements

  • Promoted to System Coordinator
  • Promoted to Site Supervisor

Education

Master of Business Administration - Information Technology Business Administration

Curry College
Milton, MA
09.2016

Master of Computer Information Systems - Information Technology Project Management

Boston University
Boston, MA
05.2020

Skills

  • GxP Systems Validation
  • GxP Change Control Management
  • GxP Software Development Lifecycle (SDLC)
  • Standard Operating Procedure (SOP) Management
  • Process Optimization
  • People Development
  • Project and Program Management
  • Technical Writing
  • Regulatory Requirements (21 CFR Part 11, Annex 11)
  • Enterprise Resource Planning Software
  • Enterprise Architecture
  • Resource Management
  • Vendor Management
  • Cloud Services (AWS, Azure, Oracle)

Certification

  • Scrum Alliance Certified Scrum Product Owner (CSPO)
  • Scrum Alliance Certified Scrum Master (CSM)

LinkedIn

  • www.linkedin.com/in/alvin-brewster

Technology

  • Workday
  • ServiceNow IT Service Management, Change Management, IT Operations Management, Governance, Risk, and Compliance
  • Qumas Quality Management System
  • Veeva GxP Document Control and SOP Management
  • Oracle E-Business Suites/Oracle NetSuite
  • SAP ERP
  • Intuit Quickbooks ERP
  • Salesforce Service Process Management
  • Salesforce Service Operations
  • IDBS Electronic Lab Notebook
  • Dotmatics Electronic Lab Notebook
  • Empower Chromatography Data System
  • H&A Scientific Stability Lab Management Software
  • Nugenesis Lab Management System
  • Vaisala Veriteq Continuous Monitoring System
  • Hewlett Packard Application Life Cycle Management
  • Tulip Manufacturing Application Platform
  • JIRA
  • Asana

Timeline

Business Engagement & Technology Principal Analyst

Vertex Pharmaceuticals
07.2021 - Current

Business Engagement & Technology Senior Analyst II

Vertex Pharmaceuticals
12.2018 - 07.2021

IT Business Analyst

Biogen
01.2014 - 02.2018

Security Officer / Security Systems Coordinator / Site Supervisor

Biogen, Securitas Security Services
10.2010 - 01.2014

Master of Business Administration - Information Technology Business Administration

Curry College

Master of Computer Information Systems - Information Technology Project Management

Boston University
ALVIN BREWSTER