Stability Scientist (Yacht Life Sciences)
Yacht Life Sciences has a vacancy for a Stability Scientist at our client in Leiden.
As a Stability Scientist, you will:
- be completely responsible for Stability Studies from implementation of Study Plans, overseeing the process of obtaining samples from production area and labeling, documentation, studies initiation and running, overseeing performance, data review, to approval of final time-point Study Report
- ensure that stability studies are conducted in full compliance with GMP and in accordance with Pharmaceutical ICH Guidelines, and pharmacopoeia requirements (USP, Eu Ph, BP): samples are pulled within pull windows, tested using stability indication methods (validated/qualified), and results are assessed according to approved shelf-life specification
- build stability studies in LIMS
- review internal and external test results/raw data (on paper and in LIMS), approving of assay trending
- perform stability data interpretation and statistical trending for products under stability program
- handle aberrant, out-of-trend and out-of-specification results in stability program
- act as a members in TI sub-teams and providing technical input in development of stability indicative methods
- assign shelf-life periods to drug products and issuing shelf-life statements
- work closely with CROs in outsourcing of stability studies to third parties
- effectively contribute to process of improvements by successfully solving quality incidents (events/deviations/CAPAs/CC) related to stability program
- support preparation / updated of new procedures, test instructions, equipment instructions, if required
- Must have completed PhD degree in Bio- or Pharmaceutical Sciences
- Minimal 3 years of experience as a Scientist in design, management and reporting of stability studies, preferably in industrial/commercial environment working to GMP standards
- Experience with analytical methods qualification/validation
- Knowledge of statistical analyses and data trending
- Experience working with CROs advantageous
- Preferable, experience in stability study design, management and reporting of stability data for IND/IMPD/NDA
- Accurate, flexible, pro-active and capable to build good relations with all stakeholders
- Capable of keeping the overview and to optimize processes in a dynamic, strong growing environment
- Highly motivated, a good organizer, good sense for details, and enjoy working in a team
We will offer a competitive benefits package in line with the seniority of this Scientist position. This Scientist position can also be performed as a freelancer (ZZP).
You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.
A global biotech company that focuses on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases.
Voor meer informatie neem je contact op met Edwin Parlevliet via telefoonnummer +31 0612387998
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.