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
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
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
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
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
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
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
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
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, MA2014
Supervisor Leadership Certificate -
2 Day Course
Lowell, MA2009
High School Diploma -
Greater Lawrence Vocational High School
Andover, MA05.1996
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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