Samir Padua
Poseida Therapeutics Inc.
Costa Mesa,CA
19
years of professional experience
1
Certification
Chemical Engineer with more than 18 years in GMP manufacturing operations, including drug substance of glycoproteins, human and humanized monoclonal antibody, drug product CAR T-Cell Therapy, and fill and finish. Successful experience from design phase, start up, and license approval of new facilities with proven performance in technical support, quality, and regulatory compliance.
Work History
Sr. Manager Validation
6 Years 7 Months- Authored and approved validation master plans for computer systems, laboratory instrumentation, facilities and utilities, and manufacturing equipment.
- Developed and implemented validation program for clinical and commercial operations, including validation policy, procedures, and plans.
- Implementation of validation program. Authored validation procedures for computer systems validation, manufacturing processing equipment, laboratory instrumentation, and facility and utilities.
- Implementation of QMS programs according to ICH guideline.
- Implemented of GAMP guidance practices in CSV program.
- Assess, review, and approve equipment design document requirements.
- Start up of new facility, including design, commissioning and qualification of facility, utilities, computer systems, manufacturing process equipment, and quality control laboratory instrumentation.
- Provided necessary technical expertise for troubleshooting and resolving exceptional conditions and deviations for processes and equipment.
- Authored, executed EMPQ of new facility.
- Implementation of Aseptic Process Validation according to Sterile Drug Products Produced by Aseptic Processing —Current Good Manufacturing Practice.
- Implemented Risk Management Program for Clinical Operations
- Implemented Periodic Review program for validated systems.
Senior Process Engineer I & II
2 Years 7 Months- Responsible to provide technical and scientific leadership as subject matter expert (SME) to manufacturing support, technology transfers, critical deviations, equipment troubleshooting, CAPA , change control, and equipment qualification.
- Implemented three capital projects as change owner, responsible to initiate, plan, control, and measure capital and departmental projects to increase process efficiency, compliance, and reliability.
- Start up of new facility to increase manufacturing capacity by qualifying two new manufacturing suites, including equipment and facility qualification, aseptic process validation, and BLA revision and submission support.
- Supported audits from regulatory agency (EMA, FDA, and TGA) as main presenter for process equipment and manufacturing deviations.
- Accountable for process and equipment risk assessments.
- Responsible and accountable for new technology introduction in commercial operations.
- Perform multi-shift work as well as on call duties if required.
- Author and lead investigator of major and critical deviations.
- Responsible to write and review technical documentation (batch records, SOPs, deviations investigation reports, technical reports, protocols & reports for equipment qualifications, process and cell therapy manufacturing process validation).
- Cell Therapy manufacturing operations SME.
Senior Validation Engineer
1 Year 7 Months- Start up of improved existing facility for monoclonal antibodies, leading and supporting operations change from clinical to commercial operations.
- Implemented process validation program from strategy definition, validation master plan, analytical testing, characterization requirements, protocols authoring, execution, and reports authoring.
- Lead and support internal and CMO process validation program, including but not limited to cell culture, harvest, downstream purification, LIVCA, and viral safety evaluation and qualification
- Lead and support qualification of laboratory and manufacturing equipment, facilities, utilities, computer related systems, and cleaning validation.
- Support Factory Acceptance Test, Site Acceptance Test, and commissioning activities.
- Responsible and accountable of remediation of manufacturing control system (Delta V) project.
- Support internal and external audits as process validation SME.
- Support quality systems non- conformance, CAPA, and change management as both owner and quality contact. Ensure manufacturing practices and process complies with internal policies and procedures, guidelines, and regulations.
- Support development of single use systems program.
Process Engineer
1 Year 3 Months- Commissioning and process equipment qualification, process validation for new or renovated construction projects.
- Development of qualification and validation documents, manufacturing procedures, non-conformance event reports,technical reports and design documents.
- Implementation of process optimization and process compliance to customer requirements and specifications.
- Ensure client manufacturing practices and process complies with internal policies, guidelines, and procedures.
- Development, review, and approval of process validation documents, but not limited to large scale studies, protocols, master plans, and reports.
Inspection and Packaging System Owner
4 Years 9 Months- Implemented two new automatic inspection machines from characterization, qualification, preventive and predictive maintenance to daily technical support.
- Completed more than 5 capital and departmental project to reduce false rejects, optimizing process yield performance.
- Supported internal audits and external inspections from FDA.
- Increased manual visual inspection process capacity about 52% by designing, qualifying, and implemented new equipment for manual inspection of vials. Including gauge repeatability and reproducibility studies and staff certification on manual inspection process.
- Reduced automatic inspection equipment downtime about 20% by improving equipment maintenance program.
- Reduced syringes glass breakage from about 18 ppm to 8 ppm. Outcome of facility performance and compliance gap analysis to reduce final product physical exposures in 2009.
- Supported more than 10 risk assessments for existing and introduction of new products.
- Generated and approved system user requirements and design documents for visual inspection equipment.
- Reduced false rejection rate of syringes and vials about 10% from design of experiments to implementation of improvements.
- Authored technical reports supporting deviations and corrective actions.
- Authored, reviewed, and approved more than 50 investigation reports.
- Responsible to initiate, plan, control, and measure capital and departmental projects to increase process efficiency, compliance, and reliability.
- Managed direct reports and interact with multidisciplinary groups for project concept design and implementation according to resources and budget constraints.
- Accountable for process and equipment validation life cycle.
- Responsible of facilities improvements. Designed, planned, and managed packaging rooms improvements during shut downs periods.
Manufacturing Specialist (Drug Substance)
5 Years 4 Months- Supported technology transfer of Neulasta from Amgen ATO to Amgen AML.
- Started up of purification area of new commercial facility from design phase, qualification, PPQ runs, inspection to licensed commercial operations.
- Increased process yield by implementing process improvement. Improvement of chromatography process step, including column bed volume and packing process, packing equipment design, computer control system re-design and improvement, and chromatography media quantification.
- Reviewed and approved purification area systems user requirements and design documents of equipment and process control system.
- Executed equipment factory acceptance test, site acceptance test, instrument check out, and automation check out.
- Reviewed, executed or approved qualification documents during facility start up of equipment and process control system.
- Responsible and accountable of area performance according to performance indicators.
- Technical lead and primary point of contact of purification systems and manufacturing equipment.
- Downstream process and equipment subject matter expert.
- Primary change owner. Leading technical projects into commercial operations.
- Generation and approval of standard operating procedures and manufacturing batch records.
- Support quality systems non- conformance, CAPA, and change management as owner. Generation, review, and approval of investigation reports.
- Responsible in designing and implementing corrective actions for tangential flow filtration system contamination event within multidisciplinary team environment.
Education
Bachelor of Science - Chemical Engineering
Bachelor of Arts - Industrial Chemistry
Skills
Aseptic Process Qualification
Cell Culture
Clean Room Qualification
Design of Experiments and Six Sigma methodology
Deviations and Corrective Actions
Equipment Design
Process Performance Optimization
Project Management
QMS
Risk Assessment
Small and Large Scale Chromatography
Tangential Flow Filtration
Technology Transfer
Validation (CSV
Equipment
PPQ)
Proficient on analytical test method development.
Proficient on large scale (Reactors
Chromatography and Filtration Skids) and small scale equipment (GC
HPLC
AKTA).
Certification
Project Management Professional, PMI
Timeline
Sr. Manager Validation
Poseida Therapeutics Inc.
03.2020 - CurrentRead More
Senior Process Engineer I & II
Kite Pharma
08.2017 - 03.2020Read More
Senior Validation Engineer
Gilead Sciences
12.2015 - 07.2017Read More
Process Engineer
ProPharma Group Inc.
08.2014 - 11.2015Read More
Inspection and Packaging System Owner
Amgen
07.2008 - 04.2013Read More
Manufacturing Specialist (Drug Substance)
Amgen
03.2003 - 07.2008Read More
Polytechnic University of Puerto Rico
Bachelor of Science from Chemical Engineering
Read More
University of Puerto Rico - Humacao
Bachelor of Arts from Industrial Chemistry
Read More