Summary
Overview
Work History
Education
Skills
Timeline
Generic

Saida Hilario

Hudson,NH

Summary

Dedicated and Experienced bioprocess Engineer offering 8 years of experience in the pharmaceutical industries. Comfortable handling a wide range of complex challenges from numerous manufacturing laboratory practices. Knowledgeable in equipment and process validation, test development and data analyzing. Detail-oriented and effective problem solver who strives to improve production efficiency and support organizational change.

Overview

8
8
years of professional experience

Work History

Senior Bioprocess Engineer

Synlogic
Cambridge, MA
09.2022 - 02.2024
  • Responsible of leading date to date support Leading day-to-day support for bench and clinical production, including media/buffer prep, basic maintenance of single use fermentation systems, centrifugation, tangential flow filtration, lyophilization and various pieces of analytical equipment
  • Working directly with our partnered CMO for day-to-day cleanroom operations, raw material procurement and management, quality systems, and shipment of material to clinical sites
  • Problem solving to troubleshoot day to day challenges to meet aggressive manufacturing timelines
  • Innovating current processes where applicable to add efficiencies and reliability to process execution
  • Aiding in all aspects of process tech transfer from process development, downstream processing, and formulation to our manufacturing cleanroom
  • Developing and managing Standard Operating Procedures (SOPs) according to GxP regulations including batch records, and accurately complete documentation associated with preclinical or clinical manufacturing
  • Participating in deviation, CAPA, and change control write-ups facilitating the release and drug product destined for use in clinical studies.

Manufacturing Associate 3

Lonza
Portsmouth, NH
07.2020 - 09.2022
  • Responsible for Mrna/COVID-19 vaccine under Good Manufacturing Procedure (GMP) conditions
  • Trained new employees on all Lonza SOPs and GMP/GDP regulations
  • Set up and execute production recipes by following written Standard Operating Procedures (SOPs) and monitor equipment processes by utilizing Human Machine Interface (HMI) systems
  • Set-up and perform Tangential Flow Filtration (TFF)
  • Generate production reports following good documentation procedures (GDPs)
  • Independently perform laboratory tasks including; equipment maintenance troubleshooting, conductivity testing and product sampling
  • Perform materials movement and transfer of chemicals across the production areas
  • Maintain facility and manufacturing equipment through routine cleaning and sanitization as a part of the 6S program
  • Attending shift exchange communication meetings and providing required training to associates as needed
  • Participating in production yield improvement and product development projects.

Senior Process Development

Pfizer
Andover, MA
10.2018 - 02.2020
  • Responsible for working in a GMP/GDP clean room environment with a focus on downstream process and solution formulation
  • Support company goals and objectives, policies/procedures, and FDA regulations
  • Collect and document daily batch records, analyze finished product data and log results in production tracker
  • Exercise leadership, provide guidance and training to production associates
  • Maintain certifications for calibrated equipment, maintenance documentation, machine history, and all other appropriate documentation for production equipment
  • Assist with materials inventory counting and tracking.

Process Development Technician

E Ink Corporation
Billerica, MA
08.2016 - 10.2018
  • Responsibilities involved executing batch processes in a controlled lab environment
  • Handle specific chemical materials in accordance to current safety guidelines and requirements
  • Working closely with scientists and engineers in conducting various batch runs as required
  • Interface with various types of processing equipment to perform multiple operations within the lab requirements
  • Create daily detailed reports of all batches processed which includes chemicals used, formulas and mathematical calculations
  • Assist engineers for improvements in various manufacturing processes to achieve higher production output results
  • Performed procedures in a GMP regulated environment

Education

Associate Degree - Biotechnology -

Middlesex Community College
05.2018

Skills

  • Training & Mentoring
  • Process Validation
  • Chemicals Handling
  • Leadership Skills
  • Verbal and Writing Skills
  • Product Specs/Process Procedures
  • Equipment Calibration
  • Microsoft Office
  • Lean Manufacturing 6S
  • Process Improvement
  • Quality Control
  • System Troubleshooting
  • Manufacturing Processes development

Timeline

Senior Bioprocess Engineer

Synlogic
09.2022 - 02.2024

Manufacturing Associate 3

Lonza
07.2020 - 09.2022

Senior Process Development

Pfizer
10.2018 - 02.2020

Process Development Technician

E Ink Corporation
08.2016 - 10.2018

Associate Degree - Biotechnology -

Middlesex Community College

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Saida Hilario