Summary
Overview
Work History
Education
Skills
References
Timeline
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Robert Casado

Salem,NH

Summary

As a Manufacturing Technical Engineering Manager at GSK, with over 20 years of biotechnology experience and a WPI Advanced Downstream Certificate to one of the world's leading healthcare companies. Responsible for the technical engineering of the MAPS Process, a novel multiple antigen presenting system that enhances the immune response to vaccines and therapeutics. Ensure the quality and compliance of the buffer make-up, reaction steps, TFF, filtration steps, and BSC operations, using expertise in quality control, validation, quality system, SOPs, batch records, deviations, CAPAs, and change control. Also, lead and mentor a team of associates, technical writers, deviation writers, suite coordinators, and supervisors, fostering a culture of excellence and continuous improvement. Collaborate with key stakeholders in daily functional meetings, client meetings, senior staff meetings, and the global safety team, to deliver high-quality products that improve the lives of patients and advance the field of biotechnology. Passionate about innovation and communication, and hold a certification in Speaking Confidently and Effectively from LinkedIn, which helps convey ideas and insights effectively.

Overview

24
24
years of professional experience

Work History

Technical Engineering Manufacturing Manager

GSK
Cambridge MA
11.2022 - Current
  • Technical Engineering Manager of MAPS Process (Multiple Antigen Presenting Systems)
  • Oversee day to day MFG operations which include buffer make-up, reaction steps, TFF, filtration steps, BSC operations
  • Mentoring associates, technical writers, deviation writers, suite coordinators, supervisors
  • Write and approve CAPAs, Change Controls, Deviations, SOPs, batch records, forms
  • SAP implementation by creating BOMs for batch records.
  • Work with validation team with implementation of in house WFI system.
  • Wrote SOP, OJT, and updated batch records to include procedures for using WFI system.
  • Work with key stakeholders in daily functional meetings that include manufacturing schedule, manufacturing leadership team meetings, triage for deviations, CAPAs, Change Controls, SAP implementation.
  • Led 2023 MBR blitz to reduce backlog of MBRs and ensure MBRs are reviewed real time and closed out to be ready for batch disposition.
  • Work with Site EH&S to continue to ensure a safety culture is practiced and improved.
  • Collaborate with GSK global on projects.
  • Internal and external audit support.
  • Supervised production team, keeping production schedules on track to meet tight deadlines.

Sterile Fill Finish / RNA Manufacturing Manager

Pace Life Sciences
Salem NH
03.2022 - 10.2022
  • Oversee day to day manufacturing operations.
  • Attend client meetings to discuss schedule.
  • 6 Direct Reports
  • Create and edit manufacturing schedule.
  • Coordinate with Facilities to schedule PMs, calibrations.
  • Work with vendors to get quotes and schedule equipment services.
  • Create, revise, and review, and approve SOPs, batch records, forms.
  • Initiate, investigate, and approve deviations, CAPAs, Change Control
  • Attend weekly Senior Staff meetings to discuss site revenue and timelines.
  • Active member of Global Safety Team
  • Ordering of manufacturing equipment and consumables
  • Certificate of Analysis Approver working closely with Supply Chain
  • Revise and create Material Specifications for incoming consumables and raw materials.
  • Oversee fill/finish operations.
  • Host client visits and provide department tours.
  • Write direct report review and goals.
  • Mentor direct reports by giving advice and supporting them to help achieve their personal and business goals.
  • Managed budget planning and forecasting activities for the manufacturing department, ensuring alignment with corporate financial goals while maintaining operational excellence.

Clinical Manufacturing Supervisor

Translate Bio a Sanofi Company
Lexington MA
05.2021 - 04.2022
  • Manage manufacturing scheduling
  • Drug Product, Drug Substance
  • Manage External Clinical Manufacturing Operations using On Demand Cleanrooms, Validation effort point of contact and coordination
  • EMPQ and Dynamic Testing to qualify and prep GMP cleanroom operations
  • Initiate, write, participate with Deviation, Change Control, CAPA and non-conformances.
  • Key core member of cross functional team working collaboratively with QA, QC, Validation, Supply Chain, and CMO
  • Work closely with Supply Chain, Procurement for incoming materials/supplies with new and existing vendors.
  • Create, revise, review, and approve SOP, Master Batch Record, and logbooks.
  • Review and approve executed batch records.
  • Participated in departmental meetings to share insights from the manufacturing floor, contributing valuable input towards decision-making.

SR Research Associate

Ultragenyx
Woburn MA
06.2018 - 04.2021
  • Mentored Coops and onboarding Research Associates, with hands on training, overseeing processes and delegating tasks where deem fit
  • Including but not limited to interview panel for potential candidates ranging from Coops to Senior Staff level.
  • Subject Matter Expert for Downstream Pilot Process Development Team, direct involvement of Downstream Pilot Plant scales up process development.
  • Working with manufacturing operations team to support (Person In Plant) GMP production at CMO partners
  • Communicated research and analytical findings to research team
  • Developed logic models, performance measures and data collection programs
  • Verified meticulous recording of all data changes immediately upon alteration of project scope
  • Managed study site and used Arxspan ELN to safeguard high-quality data
  • Implemented resin tracking and usage to better understand resin cycling
  • Maintained detailed records of experimental protocols and data in laboratory notebooks
  • Conducted independent research to assimilate results for technical reports
  • Collaborated with peers and senior leadership to discuss research and data outcomes
  • Contributed to large-scale research project by ordering appropriate sized equipment
  • Achieved specific team goals, including scale-up from 250L to 500L Pilot run by collaborating with Tech Transfer to share and implement best practices
  • Represented company at external poster events.
  • Managed multiple projects simultaneously, ensuring timely completion and high-quality deliverables.

Downstream GMP Lead (6-month Contract)

New England BioLab
Rowley MA
06.2017 - 02.2018
  • Focus on manufacturing of Enzymes for Customers
  • Column Operation with various resins (Nickel Sepharose, Superdex75pg, Source30S, Source 30Q, Hydroxyapatite, Phenyl Sepharose)
  • AKTA Operations (Collecting Fractions)
  • Method Write-up on Unicorn
  • Cell Breakage
  • Working with Fermenters SIP/CIP/Media Makeup, and Buffer makeup using Inline Buffer Dilution Skid
  • TFF buffer exchange / Dialysis
  • Validation activities of equipment
  • Piping and Instrument Diagram reviews / Certification Reviews
  • Worked closely with team members to deliver project requirements, develop solutions and meet deadlines
  • Demonstrated self-reliance by meeting and exceeding workflow needs
  • Managed vendor relations and contracts through strategic partnerships which saved costs and delivered premium contract pricing.
  • Aided in commissioning of new equipment, collaborating closely with engineers to ensure smooth integration into existing systems.

SR Research Associate

Moderna
Cambridge MA
01.2016 - 04.2017
  • GLP /GMP Operations / Interview potential candidates for team
  • On floor batch record review, close out and revision
  • Deviation write up.
  • In Vitro Transcription
  • Endotoxin sampling and testing with Kinetic Tester
  • Run quantification to determine yield through Micro Plate reader
  • Run Fragment Analyzer to determine separation
  • Pack and unpack Axichrom columns with various resins (Reverse Phase Resin, dT Poros, Ceramic)
  • AKTA Pilot operations
  • Write methods on Unicorn software
  • Filter drug substance, TFF.
  • Assisted 4 scientists with in-depth data research in both lab and office environments.

Manufacturing Associate IV

Biogen Inc
Cambridge MA
01.2012 - 11.2015
  • Effectively facilitated daily shift hand over
  • Completed advanced downstream course at Worcester Polytechnic Institute
  • Completed Qualified Trainer course to help maximize downstream knowledge and processes.
  • Verified operation of all equipment by calling for repairs and evaluating new equipment
  • Created and revised SOPs and procedures by analyzing operating practices.
  • Maintained workflow by monitoring steps of processes and observed equipment.
  • Noted equipment problems and requested maintenance support to minimize downtime.
  • Managed all areas of manufacturing, safety, inventory control and process implementation.
  • Actively participated in safety meetings and checked team compliance with protective equipment and behavioral practices.
  • Provided employee coaching and employment decisions.
  • Followed safety protocols and utilized OSHA-approved PPE to foster safe working environment.

SR Technician II

Pfizer
Andover MA
09.2000 - 11.2011
  • Daily tasks delegation to team.
  • Assist Supervisor with yearly peer's review feedback.
  • Deviation Initiation, Investigation and CAPA workflow via TrackWise.
  • Real time On floor Batch Record Review, SOP Revisions / Interview potential candidates / Ensure safe work practices.
  • MES Recipe Author / SCADA / PI Trending and Inventory SAP ERP
  • Startup GMP operations to new facility
  • Buffer / Media make up
  • Column Ops
  • CIP / SIP / COP
  • Installation Qualification, Performance Qualification, Operational Qualification.
  • Inspected equipment to identify areas of wear or causes of malfunctions.

Education

Advanced Downstream Course Certification -

Worcester Polytechnic Institute
Worcester, MA
2014

Supervisor Leadership Certificate -

2 Day Course
Lowell, MA
2009

High School Diploma -

Greater Lawrence Vocational High School
Andover, MA
05.1996

Skills

  • Downstream SME
  • Documentation ability
  • Quality assurance standards
  • Proficient in chromatogram analysis
  • Research protocol development
  • Document preparation
  • Data collection and analysis
  • Proficiency in Unicorn, Arxspan, Sharepoint, Oracle Procurement, Delta V, SCADA, MES, Trackwise, LIMS, SAP, and Office 365
  • Training & Development
  • Troubleshooting
  • Communication
  • Manufacturing Technologies
  • Strategic thinker
  • Production procedures

References

Available upon request.

Timeline

Technical Engineering Manufacturing Manager

GSK
11.2022 - Current

Sterile Fill Finish / RNA Manufacturing Manager

Pace Life Sciences
03.2022 - 10.2022

Clinical Manufacturing Supervisor

Translate Bio a Sanofi Company
05.2021 - 04.2022

SR Research Associate

Ultragenyx
06.2018 - 04.2021

Downstream GMP Lead (6-month Contract)

New England BioLab
06.2017 - 02.2018

SR Research Associate

Moderna
01.2016 - 04.2017

Manufacturing Associate IV

Biogen Inc
01.2012 - 11.2015

SR Technician II

Pfizer
09.2000 - 11.2011

Advanced Downstream Course Certification -

Worcester Polytechnic Institute

Supervisor Leadership Certificate -

2 Day Course

High School Diploma -

Greater Lawrence Vocational High School

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CREATE PROFILE
Robert Casado