Stability Scientist (Analytical Development) (Yacht Life Sciences)
| Branche | Techniek en productie |
| Dienstverband | Uitzenden en detacheren |
| Uren | 32 - 40 uur |
| Locatie | Leiden |
| Opleidingsniveau | Universitair |
| Organisatie | Janssen Vaccines & Prevention |
| Contactpersoon |
Edwin Parlevliet |
Informatie
Janssen Vaccines & Prevention B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson and is passionate about the development, production and marketing of vaccines to prevent and combat infectious diseases. The Drug Substance Operations (DSO) department has a GMP manufacturing facility at the Bioscience Park in Leiden where we proudly produce groundbreaking medicines against diseases that have a global impact, such as vaccines against HIV, RSV and Ebola. This is also the place where we will be producing the COVID-19 vaccine material.
Functieomschrijving
Yacht Life Sciences has a vacancy for a Stability Scientist (Analytical Development) at Janssen Vaccines & Prevention in Leiden.
As a Stability Scientist you will be a key player in the management of various stability studies of novel vaccines during clinical development. Additionally, you will work in a multidisciplinary environment and have a focus on review and approval of various scientific protocol, reports, documentation for IND/CTA filing, and provide support during scientific investigations.
Since you are providing support to various CMC projects that are carried out in teams comprising members from different departments, teamwork and flexibility are two very important characteristics that are required attributes.
Department:
Analytical development quality team is part of the Analytical Development Department of Janssen Vaccines and focuses on the design, execution and evaluation of stability profiles and qualification of Reference Materials for novel vaccines. The group supports the clinical development stages of the vaccines platforms and generates data that is used in preparation for future commercialization.
You will be working in a team of 9 Scientists managing different stability studies in different phases. You will be working on a phase 3 project that will go commercial.
Functie-eisen
- Must have a PhD Degree in Biochemistry, Analytical Chemistry, Pharmacy, or equivalent life sciences degree
- > 2 years pharmaceutical industry experience working under GMP standards or QC environment at the level of Scientist
- Experience with stability study management
- Experience with analytical methods qualification and validation
- Knowledge of statistical analyses and data trending
- Knowledge of GMP quality systems, quality management
Arbeidsvoorwaarden
We offer a challenging position which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development. This concerns a full-time secondment contract for 1 year (extension is anticipated). Full time preferred, 32 hours discussable. Salary between 3200 and 4000 euro gross per 4 week period.
We will offer a competitive benefit package in line with the seniority of the position. 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 to become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers, you will be able to follow courses and training via our Yacht Academy in order to keep your knowledge and skills up-to-date, i.e. boosting your career through personal and scientific growth.
Omschrijving
Janssen Vaccines & Prevention B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson and is passionate about the development, production and marketing of vaccines to prevent and combat infectious diseases. The Drug Substance Operations (DSO) department has a GMP manufacturing facility at the Bioscience Park in Leiden where we proudly produce groundbreaking medicines against diseases that have a global impact, such as vaccines against HIV, RSV and Ebola. This is also the place where we will be producing the COVID-19 vaccine material.
Functieomschrijving
Yacht Life Sciences has a vacancy for a Stability Scientist (Analytical Development) at Janssen Vaccines & Prevention in Leiden.
As a Stability Scientist you will be a key player in the management of various stability studies of novel vaccines during clinical development. Additionally, you will work in a multidisciplinary environment and have a focus on review and approval of various scientific protocol, reports, documentation for IND/CTA filing, and provide support during scientific investigations.
Since you are providing support to various CMC projects that are carried out in teams comprising members from different departments, teamwork and flexibility are two very important characteristics that are required attributes.
Department:
Analytical development quality team is part of the Analytical Development Department of Janssen Vaccines and focuses on the design, execution and evaluation of stability profiles and qualification of Reference Materials for novel vaccines. The group supports the clinical development stages of the vaccines platforms and generates data that is used in preparation for future commercialization.
You will be working in a team of 9 Scientists managing different stability studies in different phases. You will be working on a phase 3 project that will go commercial.
Functie-eisen
- Must have a PhD Degree in Biochemistry, Analytical Chemistry, Pharmacy, or equivalent life sciences degree
- > 2 years pharmaceutical industry experience working under GMP standards or QC environment at the level of Scientist
- Experience with stability study management
- Experience with analytical methods qualification and validation
- Knowledge of statistical analyses and data trending
- Knowledge of GMP quality systems, quality management
Arbeidsvoorwaarden
We offer a challenging position which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development. This concerns a full-time secondment contract for 1 year (extension is anticipated). Full time preferred, 32 hours discussable. Salary between 3200 and 4000 euro gross per 4 week period.
We will offer a competitive benefit package in line with the seniority of the position. 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 to become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers, you will be able to follow courses and training via our Yacht Academy in order to keep your knowledge and skills up-to-date, i.e. boosting your career through personal and scientific growth.
