Abir B.
Independent Consultant — Project Management
Experience
Independent Consultant — Project Management
Freelance
- Managed complex CAPEX and process enhancement projects for Guidepoint, AlphaSights, L.E.K. Consulting, and NanoHelix involving cleanroom expansions, automated bioprocess systems, and validation program rollouts.
- Established and maintained comprehensive project schedules integrating engineering, validation, quality assurance, and operations milestones ensuring GMP compliance and regulatory readiness.
- Oversaw FAT/SAT coordination with vendors for bioprocess skids, monitoring instrumentation calibration, and clean utility validation protocols.
Technical Project Management Consultant
GRI Pharma
- Led bioprocess equipment upgrade projects focusing on chromatography resin replacement and buffer prep system qualification within cGMP frameworks.
- Facilitated cross-functional risk assessment and mitigation planning applying FMEA and structured change control to minimize regulatory risk.
- Achieved 2-7% cost savings through supplier rationalization, value engineering, and optimized scheduling of CQV activities.
- Supported validation teams on protocol creation, execution review, and compliance reporting per Annex 1 and comparable standards.
PM and Process Advisor
Guidepoint
- Developed PM frameworks for CMC technology transfer projects ensuring integrated vendor qualification, process validation, and engineering handovers for new commercial biomanufacturing lines.
- Designed KPI dashboards and milestone tracking for manufacturing readiness levels (MRLs) improving decision-making transparency at operational and executive levels.
- Implemented risk and change control standardization facilitating compliance with EMA/FDA good manufacturing practices.
Project Manager
Cobetter Filtration
- Directed installation and qualification of single-use filtration and tubing assemblies in aseptic processing cleanrooms, ensuring full compliance with GMP and ISO standards.
- Controlled validation life cycle including FAT, IQ/OQ/PQ and cleaning validation maintaining synchronization of documentation and batch records.
- Managed vendor quality assurance and corrective action reporting to maintain supplier compliance standards and reduce 0.3-2% deviation incidents.
PM and Process Strategy Advisor
Guidepoint
PM/Sales Specialist
Cytiva (Formerly GE Healthcare Life Sciences)
- Delivered comprehensive CAPEX projects for upstream mammalian cell culture and downstream purification including bioreactors, tangential flow filtration (TFF), and chromatography systems.
- Led cross-functional teams through project execution applying Lean and Kaizen methods to improve schedule adherence and project cost efficiency.
- Ensured rigorous process validation and commissioning documentation aligned with cGMP guidelines and client quality standards.
- Coordinated cross-functional teams on a critical COVID vaccine manufacturing project, applying Lean and project management methodologies to maintain progress during time-sensitive, challenging conditions.
Summary
Project Manager & Biopharma Specialist with 5+ years of experience leading CAPEX, CMC, cleanroom, and validation projects in GMP-regulated environments across Europe and Asia. Proven track record of delivering complex bioprocess equipment installations, facility commissioning, and regulatory-ready documentation on time and within budget.
Combines technical mastery in aseptic processing, single-use technologies, and bioprocess scale-up with strategic leadership in risk management, vendor negotiation, and Lean/Six Sigma optimization. Skilled at aligning technical deliverables with business objectives, driving cost savings, and accelerating manufacturing readiness for CDMOs and global pharma.
Recognized for clear communication, stakeholder engagement, and team motivation in multicultural settings. Adept at bridging engineering execution with business strategy, ensuring compliance with FDA, EMA, and ICH standards while enabling organizational growth in competitive biopharma markets.
Languages
Education
Dublin City University
MSc in Business Management · Dublin, Ireland
KIIT University
MTech in Biotechnology · Bhubaneswar, India
KIIT University
BTech in Biotechnology · Bhubaneswar, India
Certifications & licenses
Agile Project Management Professional Certificate
Atlassian
Diploma In Bioreactor Design
Alison
Diploma In Certified Associate In Project Management, SAP Activate, Primavera P6, Planning And Estimation
Alison
ISO 13485:2016, 9001:2015, Cleanroom 6&7 And 14971:2019
Alison
AI For Business Leaders, Business Strategy And Project Management
Microsoft
Data And Business Analysis
Microsoft
Lean Six Sigma
Danaher Corporation, Linkedin, Alison
Six Sigma
Danaher Corporation, Linkedin, Alison
Six Sigma Green Belt
Danaher Corporation, Linkedin, Alison
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