NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

TOUCAN chose Kirsten Heukelbach as QA Manager at Advent Bioservices.

Kirsten Heukelbach

QA Manager at Advent Bioservices
United Kingdom
•
Dates Employed Jan 2018 – Present
Employment Duration 5 mos

•
“”Highly organized and experienced Pharmacy Production Manager with an in-depth understanding of pharmaceutical quality challenges and Good Manufacturing Practice (GMP). Manages operations supplying industry-leading services to pharmaceutical companies for Phase I and Phase II clinical trials from trial design through to report. Highly experienced in preparation of a wide variety of dose forms, sterile and non-sterile products, radiopharmaceuticals, repack/randomise/label IMPs, QP releases, controlled drugs and products for parenteral administration. Strong organisational and business acumen gained in working closely with trial sponsors and stakeholders at executive level, and in a multidisciplinary team commanding respect of medical, nursing, technical and administrative staff.
A fluent speaker of English and German and Graduate Pharmacist registered with the Royal Pharmaceutical Society and General Pharmaceutical Council of the UK with Master in Radiopharmaceuticals and PET Radiochemistry near completion.”


Experience:

Head of Pharmacy Production
Company Name Hammersmith Medicines Research Ltd
Dates Employed Aug 2005 – Jan 2018
Employment Duration 12 yrs 6 mos
Location London, United Kingdom

Maintaining and developing pharmacy services to achieve and maintain MHRA-licensed status. Directing, training, supervising and appraising staff. Developing and maintaining immaculate systems for documenting pharmacy procedures, to ensure compliance with Good Manufacturing Practice, managing the maintenance and performance-checking of pharmacy equipment, and ensuring it is serviced and calibrated as required.
Preparing IMPs, including sterile dose forms and radiopharmaceuticals, repackaging and relabelling of clinical trial supplies. Advising company and study sponsors on pharmacy work, and participating in meetings with them as necessary. Advising on and overseeing the purchasing of pharmacy equipment and materials, auditing suppliers and other third parties, as required. Writing and updating pharmacy standard operating procedure.
Advising the Medical Directors on the handling and administration of medicines, to maximise the safety of study subjects and company staff, and to minimise the likelihood of mistakes.
Training nursing and technical staff in pharmaceutical procedures, production issues and GMP principles, as necessary and appropriate.
Advising the Health and Safety Committee, and ward teams, on safe handling of materials.
Assessing safety data and writing COSHH assessments when necessary.
Liaising with pharmaceutical companies, other research laboratories and hospital departments.

Languages:
• English
• German

https://www.linkedin.com/in/kirsten-heukelbach-a2180425/

About Hammersmith Medicines Research Ltd
Pharmaceuticals London:

Specialists in clinical pharmacology phase 1 and early phase 2 trials.
https://www.hmrlondon.com/