Sarah Thirkell
Summary
Hard-working Associate Director with strong organisational skills. Achieves company goals through exceptional planning and prioritisation.
Overview
14
14
years of professional experience
3
3
years of post-secondary education
1
1
Certification
Work History
Associate Director GMP Production
Achilles Therapeutics
London
01.2024 - Current
- Oversee GMP manufacturing activities: scheduling of patients/shipments of drug products, ensuring all production activities are carried out in compliance with SOPs, GMP and regulatory requirements.
- Manage and develop a team of production scientists
- Lead departmental strategies by collaborating with team members and effectively communicating goals.
- Working closely with cross-functional teams Quality, MSAT & Patient Supply Operations to facilitate seamless project execution.
- Ensure all products meet quality standards, working with QA team to address any non-conformances and implement corrective actions.
- Manufacturing Subject Matter Expert at company Quality meetings and primary user for eQMS. Author/approver of documentations including SOPs, BMRs, change controls and risk assessments.
- Owner of departmental risk register.
- Manufacturing Subject Matter Expert at all company cross-functional meetings.
Head of GMP Production
Achilles Therapeutics
London
01.2021 - 12.2023
- Managed a team of 12 GMP operators to ensure timely delivery of clinical batches, line managed senior Production Scientists (5).
- Scheduled cleanroom manufacturing slots, receipt and shipment of procurement kits and shipment/delivery of final drug products.
- Prepared and reviewed GMP documentation (Batch Manufacturing Records, Standard Operating Procedures, change control, risk assessment and deviations).
- Manufacturing subject matter expert at cross functional meetings including Patient Supply Operations, GMP Materials and Core senior leadership team meeting.
- Successfully delivered on tasks within tight deadlines.
- Trend and report on the monthly metrics (Excel, word, power point, google sheets).
- Demonstrated respect, friendliness and willingness to help wherever needed.
Principal GMP Production Scientist
Achilles Therapeutics
London
01.2019 - 12.2020
- Lead Manufacturing Scientist for two Phase I/II clinical trials.
- Supervising team of manufacturing scientists and training of new staff members.
- Leading the stability program/protocol for intermediate batches and drug products
- Successfully delivered on tasks within tight deadlines.
- Working closely with the Quality Manager for all GMP quality events (non-conformances, risk assessments and change controls).
- Reviewed and updated process documentation: Batch Manufacturing Records, Standard Operating Procedures and Work Instructions.
- Completed duties to deliver on company targets with accuracy and efficiency.
Senior GMP Production Scientist
Achilles Therapeutics
London
09.2017 - 12.2018
- Carried out process development work for upcoming clinical trials, writing validation and stability protocols
- Supervised a small team of process development scientists.
- Sourced raw materials and built good working relations/contracts with company representatives
- Material management for all process development work and upcoming trials.
- Author of new process documentation: Batch Manufacturing Records, Standard Operating Procedures and Work Instructions.
Senior GMP Production Scientist
King's College London
London
03.2014 - 09.2017
- Working in collaboration with University of Oxford, manufacturing drug products for ThRIL trial and ONE study.
- Supervising and training new starters.
- Sourcing raw materials and material management.
- Documentation updates (Batch Manufacturing Records, Standard Operating Procedures and Work Instructions).
- Public Engagement: NHS clinical trials day, Clinical research engagement with schools.
GMP Production Scientist
University of Oxford
London
06.2012 - 03.2014
- Working in collaboration with King's College London on two phase I clinical trials.
- Development of manufacturing protocol and process documentation including SOPs, BMR's and IMPD.
- Quickly learned and applied new skills to daily tasks, improving efficiency and productivity.
- Worked flexible hours, covering nights, weekends and bank holidays.
GMP Production Assistant
University of Oxford
Oxford, Oxfordshire
10.2010 - 05.2012
- Working at the Clinical BioManufacturing Facility, gaining an understanding of Good Manufacturing Practise including product culture, purification and final filling.
Education
Bachelor of Science - Biological sciences
University of Leicester
Leicester 09.2000 - 06.2003
Skills
- 15 years GMP manufacturing experience (8 years academia and 7 years industry)
- Work experience in Cell and Gene Therapy manufacturing management /leadership roles
- Experienced in the management of risks, quality events, incidents, deviations, investigations, change controls, and CAPA
- Good understanding of drug product development process and experience in technical transfer activities
- Analytical and problem-solving skills with the ability to provide clear direction
- Strong organizational and time management skills
- Experienced in generation, review, and approval of GMP documentation (SOPs, BMRs, protocols and reports)
Certification
Risk Management (short course) - City University, Dec 2022
Timeline
Associate Director GMP Production
Achilles Therapeutics
01.2024 - Current
Head of GMP Production
Achilles Therapeutics
01.2021 - 12.2023
Principal GMP Production Scientist
Achilles Therapeutics
01.2019 - 12.2020
Senior GMP Production Scientist
Achilles Therapeutics
09.2017 - 12.2018
Senior GMP Production Scientist
King's College London
03.2014 - 09.2017
GMP Production Scientist
University of Oxford
06.2012 - 03.2014
GMP Production Assistant
University of Oxford
10.2010 - 05.2012
Bachelor of Science - Biological sciences
University of Leicester
09.2000 - 06.2003
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