Krupal Patel
Mason
Summary
Experienced leader in Supply Chain, Operations, Manufacturing Engineering, Validation, and Quality within Pharmaceutical and Biotech industries. Over 14 years of optimizing processes and ensuring compliance with industry standards. Focused on driving continuous improvement and innovation to enhance product quality and operational efficiency.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Sr. Project Manager (Facilities and Equipments)
Forge Biologics
Grove City, OH
03.2025 - Current
- Direct end-to-end execution of cell and gene therapy projects, ensuring alignment with scope, timeline, budget, and quality standards.
- Design and execute detailed project plans and schedules to effectively manage risks and optimize resource allocation.
- Identify potential project risks, implement mitigation plans, and resolve issues to ensure timely project delivery.
- Managed project to perform commissioning and qualification of critical laboratory equipment to support client production needs.
- Managed comprehensive commissioning and qualification of downstream suite, achieving 100% capacity increase.
- Facilitated collaboration among product development, regulatory affairs, quality assurance, quality control, manufacturing, and supply chain teams to improve project outcomes.
- Tracked project milestones, KPIs, budgets, and deliverables to ensure alignment with strategic objectives and communicated updates to senior leadership and stakeholders.
- Manage financial tracking of projects to ensure budget adherence and efficient resource utilization.
- Direct change control initiatives to uphold project documentation and governance in alignment with organizational standards.
- Prepared executive dashboards, project reports, and presentations for steering committee meetings to inform decision-making.
- Key Achievements:
Sr. Supply Chain Specialist
Alkermes PLC
Wilmington, OH
10.2022 - 03.2025
- Led and managed production planning of sterile (Microspheres and Polymer) and Oral solid dose (OSD) products by performing the following:
- Developed and published short and long-term production plans, enhancing scenario planning for better resource allocation.
- Managed capacity and resources to optimize production efficiency.
- Oversaw material management to ensure timely availability for production.
- Collaborated, coordinated, and led meeting with multiple teams to manage production schedules and material inventory levels.
- Identified and communicated risks and critical issues affecting product manufacturing and supply (S&OE) to facilitate proactive solutions.
- Created and tracked key supply chain metrics to monitor performance.
- Supported new product introduction, non-commercial demand, and clinical demand for the site.
- Led continuous improvement for the department.
- Analyzed data to streamline supply chain processes, contributing to operational cost reduction.
- Performed SIPOC, GEMBA and process mapping.
- Master Data Management (MDM) and Bill of Materials (BOM) management in SAP.
- Weekly/monthly alliance relationships meeting with internal and external clients.
- On Time In Full (OTIF)
- Key Performance Indicator (KPI)
- Backorder status
- Schedule adherence.
Lead Validation Engineer/Manufacturing Engineer
Alkermes PLC
Wilmington, OH
08.2018 - 10.2022
- Collaborated with cross-functional teams to ensure regulatory compliance for sterile and OSD products.
- Led the development of cleaning processes (Automated and Manual) for various manufacturing equipment.
- Integrated Quality into Manufacturing by utilizing Quality by Design (QBD) concepts during the initial process development phase.
- Executed media fill simulations to ensure sterility in aseptic processes.
- Process validation (PPQ/CPV)
- Performed cleaning validation to confirm efficacy of cleaning processes.
- Conducted sterilization processes using steam in place and autoclave methods.
- Managed cleaning and process requalification programs, ensuring compliance and effectiveness of manufacturing equipment.
- Performed statistical process analysis using JMP to identify trends and improve manufacturing processes.
- Authored technical documents (Protocols/Technical reports/SOP/Batch records/Change control) for various manufacturing areas (Aseptic\Sterile and Oral dose):
- Supported process and site improvement projects.
Project Engineer
Akorn Inc
Decatur, IL
10.2016 - 08.2018
- Project manager for multiple aseptic equipment projects such as Depyrogenation Tunnels, Autoclaves,SIP, and Incubators.
- Managed project initiation, planning, execution, monitoring, controlling, and closing.
- Collaborated with key stakeholders to align project goals and ensure timely achievement of milestones.
- Implemented GEMBA walks and Kanban board alongside Kaizen concepts to streamline departmental processes.
- Supervised contractors and consultants working on multiple projects.
- Reviewed project documents for accuracy and compliance. and approved technical documents, ensuring compliance with project standards and facilitating successful project execution.
- Performed gap and data analysis on existing processes and prepared remediation plans.
Validation/Manufacturing consultant
McNeil Healthcare
Fort Washington, PA
10.2013 - 12.2014
- Planned and managed multi-shift manufacturing activities, optimizing workflows for operational efficiency.
- Trained team members on various manufacturing processes, enhancing skill sets and ensuring adherence to standards.
- Mapped processes for consumer product manufacturing to improve efficiency.
- Conducted equipment operation and performance qualification (OQ/PQ) to ensure compliance with standards.
- Generated protocols and technical reports for various manufacturing processes.
- Consulted on consent decree remediation efforts, collaborating with external auditors to ensure compliance.
Validation consultant
CSL Behring Biotherapies
Bradley, IL
07.2013 - 10.2013
- Directed cleaning validation executions for plasma manufacturing equipment, including Girton Washers and Buffer Tanks, ensuring adherence to validation protocols.
- Executed process and cleaning validation activities by developing protocols and final reports, ensuring compliance and quality standards at a startup plasma manufacturing plant.
- Determined Maximum Allowable Carry Over (MACO) to mitigate cross-contamination risks between products.
Validation consultant
Sanofi-Pasteur
Swiftwater, PA
11.2012 - 07.2013
- Provided consultation on aseptic manufacturing equipment’s cleaning process development and validation.
- Utilized Design of Experiment (DOE) to identify the most effective detergent, concentration, and temperature of the detergent, and optimal time for cleaning to develop efficient cleaning processes for all the portfolio products.
- Identified worst-case product (protein/vaccine) for equipment cleaning from portfolio of 9 products using experimental studies and test data analysis.
- Conducted rinse and swab recovery studies to facilitate cleaning process development.
- Achieved resource cost reduction for the client by implementing efficient equipment cleaning processes.
- Assisted in quality investigations, root cause analysis, and implementation of CAPA (corrective and preventative action).
Quality and Validation contractor
Merck Pharmaceuticals
West Point, PA
05.2012 - 11.2012
- Authored and approved cleaning validation protocols and reports for aseptic/sterile injectables manufacturing equipment, ensuring compliance with cGMP requirements.
- Executed steam-in-place (SIP), clean-in-place (CIP), and clean-out-place (COP) studies on various equipment, contributing to validation of cleaning processes.
- Led cross-functional teams to optimize clinical trial operations and enhance project delivery timelines.
- Developed and implemented process improvements that streamlined data management workflows within regulatory submissions.
- Mentored junior staff on compliance protocols, ensuring adherence to industry standards and best practices.
Scientist
Amneal Pharmaceuticals
Brookhaven, NY
09.2010 - 10.2011
- Performed quality control testing of oral solid drug products (tablets and capsules) using HPLC, UPLC, and Karl Fischer instruments to ensure product integrity.
- Facilitated testing method transfer from research and development to quality control laboratories to streamline processes.
- Conducted statistical analyses on test data, enhancing accuracy and reliability of results.
Education
Master of Science - Pharmaceutical Manufacturing Engineering
Stevens Institute of Technology
Hoboken, New Jersey05-2010
Bachelor of Science - Pharmaceutical Sciences
Rajiv Gandhi University of Health Sciences
Karnataka, India05-2007
Skills
- Supply Chain Management, Production and Logistics Planning, Negotiation, Demand Planning, S&OE and S&OP, Collaboration, Client Relationship Management, Material Management, Cost Reduction, Data Analysis, Value Stream and Process Mapping, Risk Analysis, Change Control, Lean Practitioner, Validation, Engineering, Quality, 21 CFR Part 210, 21 CFR Part 211, cGMP (Good Manufacturing Practice), Process and Cleaning Development (CIP/COP) and Validation, Sterilization, Equipment Qualification, Data Integrity, Deviation Management, Root Cause Analysis, and Project Management
- Project planning
- Scope management
- Client relationship management
- Facility Planning
- Tools: MS Word/Excel/PowerPoint/Visio/Project, ERP/SAP, SmartSheet, PlanView Minitab, LIMS (Laboratory Information Management System), TrackWise, ValGenesis, JMP, and others based on the organization
Certification
- Certified Supply Chain Professional (APICS CSCP) from the Association for Supply Chain Management (ASCM). Certification ID: 173317. Expiration Date: 2027-05-31
- OpEx Green Belt.
Timeline
Sr. Project Manager (Facilities and Equipments)
Forge Biologics
03.2025 - Current
Sr. Supply Chain Specialist
Alkermes PLC
10.2022 - 03.2025
Lead Validation Engineer/Manufacturing Engineer
Alkermes PLC
08.2018 - 10.2022
Project Engineer
Akorn Inc
10.2016 - 08.2018
Validation/Manufacturing consultant
McNeil Healthcare
10.2013 - 12.2014
Validation consultant
CSL Behring Biotherapies
07.2013 - 10.2013
Validation consultant
Sanofi-Pasteur
11.2012 - 07.2013
Quality and Validation contractor
Merck Pharmaceuticals
05.2012 - 11.2012
Scientist
Amneal Pharmaceuticals
09.2010 - 10.2011
Bachelor of Science - Pharmaceutical Sciences
Rajiv Gandhi University of Health Sciences
Master of Science - Pharmaceutical Manufacturing Engineering
Stevens Institute of Technology