Scientific Stability Lead(Job Number: 00000SA6)
Description
Crucell is a global biotech company that focuses on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. Within Crucell talented, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Crucell.
For our department we are currently seeking for a fulltime Scientific Stability Lead (m/f)
Department:
The Drug Product Development department (DPD) consists of the Formulation Development and the Fill/Finish Process groups. The department is responsible for formulation development, fill/ finish process development as well as preparations for and technical oversight of drug product manufacturing at contract manufacturing organizations (CMOs).
The open position is in the Formulation Development group. This group is responsible for developing and optimizing bulk drug substance and drug product formulations, as well as conducting in-use stability studies. Furthermore, the group recently accepted the responsibility for bulk drug substance and drug product stability strategy covering ICH and non-ICH stability studies.
Job Description:
We are looking for a motivated scientist with stability expertise in a pharmaceutical environment who enjoys working in a multidisciplinary team. The responsibilities entail:
Accountable and responsible for the stability testing strategies for investigational products and documenting these strategies in stability master plans
Review of stability plans and reports, which are written by the Quality Control department based on the stability master plan).
Responsible for having an overview of available stability data per product (ICH and non-ICH stability data, formulation development data, etc.). Writing stability section in regulatory documents.
Leading stability OOS (out-of-specification) and OOT (out-of-trend) investigations
Point of contact for temperature excursions during storage & distribution of clinical materials; responsible for the impact assessments
We offer a challenging position which allows you to work on different types of interesting products in various stages of development (preclinical through late stage). Since Crucell is part of Johnson & Johnson, you will work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development.
Qualifications
Ph.D. in biochemistry, pharmaceutical sciences, analytical chemistry or a related discipline. Experience with designing and reporting stability studies for biopharmaceuticals. In depth knowledge of applicable regulatory guidelines and expectations as well as industry standards. Familiarity with analytical and statistical concepts.
Competences
The candidate fit for the job is pro-active and flexible. Business acumen, accuracy, a strong quality mindset, as well as excellent organizational and communication skills are key for this position.
What’s in it for you…? “Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously. As part of a global team in an innovative environment your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth. Our benefits make sure we care for you and your family now and in the future.
Will you be our new colleague? Please apply online.
Primary Location:Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Organization: Crucell Holland BV (8852)
Job Function: R&D
Description
Crucell is a global biotech company that focuses on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. Within Crucell talented, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Crucell.
For our department we are currently seeking for a fulltime Scientific Stability Lead (m/f)
Department:
The Drug Product Development department (DPD) consists of the Formulation Development and the Fill/Finish Process groups. The department is responsible for formulation development, fill/ finish process development as well as preparations for and technical oversight of drug product manufacturing at contract manufacturing organizations (CMOs).
The open position is in the Formulation Development group. This group is responsible for developing and optimizing bulk drug substance and drug product formulations, as well as conducting in-use stability studies. Furthermore, the group recently accepted the responsibility for bulk drug substance and drug product stability strategy covering ICH and non-ICH stability studies.
Job Description:
We are looking for a motivated scientist with stability expertise in a pharmaceutical environment who enjoys working in a multidisciplinary team. The responsibilities entail:
Accountable and responsible for the stability testing strategies for investigational products and documenting these strategies in stability master plans
Review of stability plans and reports, which are written by the Quality Control department based on the stability master plan).
Responsible for having an overview of available stability data per product (ICH and non-ICH stability data, formulation development data, etc.). Writing stability section in regulatory documents.
Leading stability OOS (out-of-specification) and OOT (out-of-trend) investigations
Point of contact for temperature excursions during storage & distribution of clinical materials; responsible for the impact assessments
We offer a challenging position which allows you to work on different types of interesting products in various stages of development (preclinical through late stage). Since Crucell is part of Johnson & Johnson, you will work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development.
Qualifications
Ph.D. in biochemistry, pharmaceutical sciences, analytical chemistry or a related discipline. Experience with designing and reporting stability studies for biopharmaceuticals. In depth knowledge of applicable regulatory guidelines and expectations as well as industry standards. Familiarity with analytical and statistical concepts.
Competences
The candidate fit for the job is pro-active and flexible. Business acumen, accuracy, a strong quality mindset, as well as excellent organizational and communication skills are key for this position.
What’s in it for you…? “Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously. As part of a global team in an innovative environment your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth. Our benefits make sure we care for you and your family now and in the future.
Will you be our new colleague? Please apply online.
Primary Location:Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Organization: Crucell Holland BV (8852)
Job Function: R&D