Analytical Technical Integrator (Project Manager Analytical Development)(Job Number: 00000TM9)
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 Analytical Technical Integrator (Project Manager Analytical Development)
Department
The Analytical Technical Integrator is part of the Analytical Development department (AD) of Crucell. AD is responsible for among other method development and validation, QC release and stability testing, outsourced testing, viral safety studies, and product characterization during the preclinical and clinical development phases until commercial launch of a vaccine.
Job description
The Analytical Technical Integrator leads the analytical team working on a project and is responsible for developing analytical development strategies aligned with the CMC strategy. He/she is representing the analytical department within the vaccine development organization and manages planning and execution of analytical deliverables and is coordinating project transfer between phases (early, late development and commercial launch). The Technical Integrator is accountable for the deliverables of the analytical department in the CMC project team. Within this role you work closely with team members in AD and other departments like CMC, QA, drug substance/drug product development, external vendors, and strategic suppliers. You are responsible for authoring documents/dossiers and support writing of regulatory submissions, amendments, annual reports, and agency responses.
Qualifications
Qualifications
• MS degree in chemistry, pharmacy or equivalent in life sciences. Advanced degree is preferred.
• A minimum of 6-8 years of experience within the pharmaceutical industry.
• In depth operating knowledge of functions involved in analytical within drug development/commercialization process.
• Experience with vaccines is preferred.
Competences
• Project management
• Influencing skills
• Writing and communication skills
• Working in a matrix environment
• Interpersonal skills
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: Product Development
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 Analytical Technical Integrator (Project Manager Analytical Development)
Department
The Analytical Technical Integrator is part of the Analytical Development department (AD) of Crucell. AD is responsible for among other method development and validation, QC release and stability testing, outsourced testing, viral safety studies, and product characterization during the preclinical and clinical development phases until commercial launch of a vaccine.
Job description
The Analytical Technical Integrator leads the analytical team working on a project and is responsible for developing analytical development strategies aligned with the CMC strategy. He/she is representing the analytical department within the vaccine development organization and manages planning and execution of analytical deliverables and is coordinating project transfer between phases (early, late development and commercial launch). The Technical Integrator is accountable for the deliverables of the analytical department in the CMC project team. Within this role you work closely with team members in AD and other departments like CMC, QA, drug substance/drug product development, external vendors, and strategic suppliers. You are responsible for authoring documents/dossiers and support writing of regulatory submissions, amendments, annual reports, and agency responses.
Qualifications
Qualifications
• MS degree in chemistry, pharmacy or equivalent in life sciences. Advanced degree is preferred.
• A minimum of 6-8 years of experience within the pharmaceutical industry.
• In depth operating knowledge of functions involved in analytical within drug development/commercialization process.
• Experience with vaccines is preferred.
Competences
• Project management
• Influencing skills
• Writing and communication skills
• Working in a matrix environment
• Interpersonal skills
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: Product Development