Summary
Overview
Work History
Education
Skills
Affiliations
Accomplishments
References
Timeline
Generic

Angelika Matynia

Summary

Dynamic bioprocess professional with extensive experience at MSD Biotech Dublin, excelling in Good Manufacturing Practices and quality assurance. Proven track record in leading production activities, mentoring teams, and driving continuous improvement initiatives. Adept at issue resolution and effective communication, ensuring compliance and operational excellence in biopharmaceutical manufacturing.

Overview

7
7
years of professional experience

Work History

Downstream Senior Bioprocess Associate

MSD Biotech Dublin
Swords
12.2024 - 07.2025
  • Facilitated and executed daily production activities within the Final Purification and Formulation suite, alongside existing responsibilities in the Initial Purification and Column Packing areas.
  • Mentor new colleagues on production systems and offline equipment.
  • Oversee production operations in Initial Purification suite as needed.
  • Handled troubleshooting and escalation of issues faced during production activities.
  • Conducting shift-to-shift handover.
  • Act as the Area Lead and Subject Matter Expert, guiding Column Packing activities for the shift team.
  • Contributed to Column Packing Work Instruction integration project, maintaining alignment with other shift teams and Technical Operations team while achieving document completion within project timeline.

Downstream Bioprocess Associate

MSD Biotech Dublin
Swords
01.2022 - 11.2024
  • Facilitating and executing daily production activities in the Initial Purification suite, as per Work Instructions and Standard Operating Procedures.
  • Execute the timely completion of Electronic Batch Records and protocols.
  • Operate and monitor automation system production recipes while in production, ensuring adherence to quality standards, and critical process parameters.
  • Escalate and aid in troubleshooting issues encountered during production.
  • Assisting with activities in other downstream suites, as required.
  • Executed column packing activities in alignment with relevant work instructions and standard operating procedures while leading the area for ongoing training.
  • Completed a Continuous Improvement project on area handover board to facilitate clear communication between shifts.

Document Controller

MSD Biotech Dublin
Swords
05.2021 - 11.2021
  • Facilitated the Manufacturing Science and Technology (MS&T) department in the development, review, and approval of various NPI documentation, such as production protocols for Formal Stability Studies (FSSs), and Process Performance Qualifications (PPQs).
  • Managed tracking of Quality Notifications (QNs) and Corrective and Preventative Actions (CAPAs) to ensure compliance for the team.
  • Updated Functional Requirement Specification (FRS) documents in collaboration with Automation and Process Engineering team.
  • Delivered updates regarding documentation timelines at cross-functional team meetings.

Medical and Promotional Compliance Administrator

Aspen Pharma Trading Limited
Citywest
12.2019 - 04.2021
  • Facilitated organisation and management of Promotional Compliance audits across global Aspen affiliate sites.
  • Oversaw tracking of various activities executed by Medical and Promotional Compliance function, ensuring all Key Performance Indicators met.
  • Administered training for newly appointed global medical approvers on the Learning Management System (LMS).
  • Coordinated delivery of annual Pharmacovigilance training to all Aspen affiliate teams and associated third-party providers.
  • Developed Work Instruction detailing relevant activities for conducting Promotional Compliance Audit.

Student Batch Release Administrator

Nypro Healthcare
Bray
02.2018 - 08.2018
  • Inspect completed manufacturing records to ensure alignment with product quality standards, and documentation guidelines.
  • Facilitate the release of required, satisfactory batches within the Quality Management System.
  • Prepared and updated Standard Operating Procedures, Work Instructions, and checklists for batch release activities.
  • Facilitated cross-training of colleagues on reviewing and releasing batch manufacturing records for various products.
  • Supported Incoming Inspection processes for vendor components used in manufacturing.

Education

Bachelor of Science - Pharmaceutical Sciences

Technological University Dublin
Tallaght, Dublin
07-2019

Skills

  • Good Manufacturing Practices (GMP)
  • Good Documentation Practice (GDocP)
  • Quality assurance
  • Continuous improvement
  • Collaborative teamwork
  • Issue resolution
  • Time management
  • Training coordination
  • Attention to detail
  • Effective communication
  • Batch record execution
  • Task prioritization
  • Production support
  • Cross-functional collaboration

Affiliations

  • Crochet
  • Knitting
  • Reading

Accomplishments

  • Presented final year project poster at SURE Conference 2019 on the topic 'Predicting whether a cancer is benign or malignant using the Wisconsin Breast Cancer Diagnostic Dataset'
  • Awarded the Nypro Recognition Award during college placement as a student batch release administrator for decreasing the certificate of analysis turnaround by 46%

References

References available upon request.

Timeline

Downstream Senior Bioprocess Associate

MSD Biotech Dublin
12.2024 - 07.2025

Downstream Bioprocess Associate

MSD Biotech Dublin
01.2022 - 11.2024

Document Controller

MSD Biotech Dublin
05.2021 - 11.2021

Medical and Promotional Compliance Administrator

Aspen Pharma Trading Limited
12.2019 - 04.2021

Student Batch Release Administrator

Nypro Healthcare
02.2018 - 08.2018

Bachelor of Science - Pharmaceutical Sciences

Technological University Dublin

Similar Profiles

CREATE PROFILE
Angelika Matynia