Abir B.

Independent Consultant — Project Management

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Berlin, Germany

Experience

Jan 2025 - Nov 2025
11 months
Berlin, Germany

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.
Jun 2024 - Dec 2024
7 months
Berlin, Germany

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.
Apr 2023 - Mar 2024
1 year
Dublin, Ireland

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.
Feb 2023 - Jul 2023
6 months
Dublin, Ireland

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.
Jun 2022 - Jan 2023
8 months
Dublin, Ireland

PM and Process Strategy Advisor

Guidepoint

Mar 2019 - May 2021
2 years 3 months
Mumbai, India

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.

Skills

Technical Skills:

  • Bioprocess Engineering Project Leadership (Equipment Procurement: Chromatography Skids, Bioreactors, Centrifuges; Clean Utilities: Wfi, Cip/sip; Automation: Scada, Dcs)
  • Capex Lifecycle Management (Conceptual Design, Urs, Fat/sat, Iq/oq/pq)
  • Validation Lifecycle Coordination Within Gxp Frameworks (Vmp, Protocol Review, Batch Record Audits, Deviation Investigation)
  • Upstream & Downstream Process Knowledge; Gmp Aseptic Manufacturing; Single-use Systems; Critical Parameter Monitoring
  • Lean, Six Sigma, And Risk-based Approaches (Fmea, Hazop) For Compliance With Fda, Ema, Ich Q7, Annex 1
  • Risk & Change Management (Impact Assessments, Decision Logs, Mitigation Strategies, Audit Readiness)
  • Vendor & Subcontractor Management (Technical Compliance, Quality Deliverables, Cost-effective Execution)

Soft Skills:

  • Strategic Planning & Prioritization Under Tight Timelines
  • Stakeholder Communication & Cross-functional Collaboration
  • Leadership In Multicultural, Regulated Environments
  • Conflict Resolution & Negotiation With Vendors/partners
  • Decision-making Under Uncertainty And Risk
  • Adaptability To Evolving Project Scope And Regulatory Changes
  • Team Motivation, Coaching, And Performance Management
  • Strong Documentation, Reporting, And Presentation Skills

Languages

German
Elementary
English
Elementary

Education

Oct 2021 - Jun 2022

Dublin City University

MSc in Business Management · Business Management · Dublin, Ireland

Oct 2017 - Jun 2019

KIIT University

MTech in Biotechnology · Biotechnology · Bhubaneswar, India

Oct 2013 - Jun 2017

KIIT University

BTech in Biotechnology · 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

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