Summary
Overview
Work History
Education
Certification
Languages
Affiliations
Interests
LinkedIn
References
Timeline
Generic

Wania Saif

Østerbro

Summary

Experienced GMP scientist with a strong background in downstream manufacturing, biotechnology, and engineering. Skilled in ensuring compliant and efficient production within regulated pharmaceutical environments, with expertise in process execution, optimization, and quality focus. Adaptable and driven, committed to supporting reliable manufacturing outcomes and continuous improvement across the pharmaceutical industry.

Overview

6
6
years of professional experience
1
1
Certification

Work History

Product Lead, Downstream Manufacturing

AGC Biologics
Søborg
03.2024 - Current
  • Project process lead in manufacturing product support (API and cGMP manufacturing)
  • Ensure successful manufacturing of Early Stage and Late Stage GMP Batches
  • Cross-functional collaboration and stakeholder management (Operations, Development, Process Transfer, QA and Clients)
  • Ensure GDP compliance throughout the manufacturing activities
  • Ensure readiness of the Master Production Record and preparation of documentation before the batch manufacturing activities
  • Participation in project team meetings, decision making and creation of milestones.
  • Process monitoring and data analysis of the manufacturing process
  • Process monitoring and data analysis of the manufacturing process.
  • Raising and handling DEVIATIONS, CHANGE REQUESTS and CAPAS.
  • Supporting audits and readiness compliance

Solution Scientist, Manufacturing Product Support

AGC Biologics
Søborg
10.2023 - 03.2024
  • Ensured GMP compliance through effective management of deviations, change requests, and CAPAs
  • Enabled smooth production start-up by supporting buffer preparation setup and documentation for a new facility
  • Improved batch record efficiency and accuracy by contributing to electronic Batch Record implementation and template optimization
  • Resolved on-floor process issues, maintaining operational continuity and reliability
  • Strengthened compliance and audit readiness through proactive collaboration with QA

Student Assistant, Downstream Mammalian Manufacturing

AGC Biologics
Søborg
03.2022 - 09.2023
  • Gained practical experience in a fast-paced, GMP-regulated manufacturing environment
  • Prepared downstream binders used for batch production activities to ensure efficient and compliant process execution

Student Assistant, Insulin Finished Products Manufacturing Development, Product Stability

Novo Nordisk
Bagsvaerd
06.2022 - 08.2023
  • Developed a system to organize and track product stability reports using Quality Management System and Quality Management Review

Junior Chemical Engineer

Eye-D Innovation
Valby
08.2019 - 08.2020
  • Developed an innovative alginate-based snack drink targeting diabetes and obesity
  • Applied Design of Experiments (DoE) to analyze rheological behavior and perform detailed viscosity profiling
  • Participated in stakeholder meetings to support product commercialization strategy and market alignment

Education

MSc Civil Engineering - Biotechnology

Technical University of Denmark (DTU)
Kongens Lyngby

BSc Civil Engineering - General Engineering, specilisation in life sciences

Technical University of Denmark (DTU)
Kongens Lyngby

Certification

  • Cambridge International Examinations in English via British Council
  • Certificate A1, Goethe-Institut e.V.
  • Innovative microbioreactor applications and bioprocess development, EUROMBR 2019, Technische Universität Braunschweig

Languages

  • English, Advanced
  • Urdu, Native
  • Danish, Intermediate
  • German, A1

Affiliations

  • Red Barnet, Save the Children: Fundraiser
  • WWF, Animal Welfare

Interests

  • Podcasts
  • Boxing
  • Dancing
  • Travelling

LinkedIn

www.linkedin.com/in/wania-s/

References

References available upon request.

Timeline

Product Lead, Downstream Manufacturing

AGC Biologics
03.2024 - Current

Solution Scientist, Manufacturing Product Support

AGC Biologics
10.2023 - 03.2024

Student Assistant, Insulin Finished Products Manufacturing Development, Product Stability

Novo Nordisk
06.2022 - 08.2023

Student Assistant, Downstream Mammalian Manufacturing

AGC Biologics
03.2022 - 09.2023

Junior Chemical Engineer

Eye-D Innovation
08.2019 - 08.2020

MSc Civil Engineering - Biotechnology

Technical University of Denmark (DTU)

BSc Civil Engineering - General Engineering, specilisation in life sciences

Technical University of Denmark (DTU)

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Wania Saif