Johnson & Johnson Careers

Scientist Product Characterization

Leiden, Netherlands
R&D


Job Description

Requisition ID: 1905722029W

Department/Project:

The Product Characterization group within the Analytical Development department is responsible for characterization of vaccine products from early to late clinical development phases. The group defines strategies for product characterization, coordinates characterization of virus seeds, drug substance, drug product, and reference materials, and plays a leading role in comparability studies and definition of critical quality attributes.

Job Description:

• Coordinate Product Characterization deliverables for one or more products under development at VPAD, for example, AdVAc© based vaccines

• Help define characterization strategies, write characterization plans and reports and coordinate the execution of characterization plans

• Lead the definition of product critical quality attributes, together with a cross functional team

• Write, together with the CMC team, comparability plans and reports

• Write or contribute to the applicable sections of regulatory dossiers

• Participate as a team member in cross functional project teams

• Participate in (internal and external) scientific meetings by giving advice or presenting characterization strategies and results


Qualifications

Qualifications:

Education: PhD or equivalent experience in a relevant discipline such as analytical or physical chemistry, biochemistry or bio-pharmaceutical sciences

Specific Knowledge:

• Industry experience in development of biopharmaceutical or vaccine products

• Experience in regulatory filing at different clinical development phases up to and including Phase III/registration

• Experience with qualification and characterization of reference materials

• Experience with analytical comparability assessments

• Broad interest and scientific knowledge of physical chemistry and/or biology of proteins and/or viruses

• Understanding of quality systems such as GMP

• Understanding of regulatory requirements and guidelines on biopharmaceutical and vaccine development (e.g., FDA, EMA, ICH, WHO)

Experience:

• For Master level, 5 years of experience or, for PhD level, 2 years of experience after the PhD

Competences:

• Demonstrated written and oral communication skills (in English)

• Demonstrated ability to work independently and also in a team

• Multidisciplinary mindset; ability to communicate effectively across different scientific disciplines

• Excellent analytical and organizational skills

• Problem solving and results oriented; able to see and leverage different perspectives

• Pragmatic attitude

• Flexible


Primary Location
Netherlands-South Holland-Leiden-
Organization
Janssen Vaccines & Prevention BV (8852)
Job Function
R&D
Requisition ID
1905722029W