Drug Product Technical Integrator - Pharmaceuticals

DRUG PRODUCT TECHNICAL INTEGRATOR/LEIDEN, NETHERLANDS/6 MONTHS CONTRACT/45 TO 80 EUR (PER HOUR)

We are currently seeking a Full time Drug Product Technical Integrator.

The department is responsible for formulation development, fill/finish process development as well technical oversight of drug product manufacturing at contract manufacturing organizations (CMOs). In addition, the department conducts in-use stability (pharmacy manual) studies including verification of blinding procedures.

We are looking for a candidate with extensive experience in the area of drug product development from early development through commercialization.

AS DRUG PRODUCT TECHNICAL INTEGRATOR, YOU WILL:

* Lead DPD sub-teams for 1-3 projects, ensuring timely completion of the project deliverables in the DPD functional area (including supply of pre-clinical and clinical drug product batches)

* Represent DPD in the CMC team

- Signal resource or technical issues and ensure alignment within DPD and with the rest of the organization

* Contribute to the design of drug product development strategies with the functional groups in DPD

* Review and edit as responsible person the DPD-related sections in regulatory submissions.

QUALIFICATIONS

* PhD or MSc in pharmacy, engineering, chemistry or related discipline with experience within drug product development in the biopharmaceutical industry.

* Experience with projects in Phase 1-3 and beyond, as well as hands-on experience with formulation development, fill/finish processes and/or GMP manufacturing are strong advantages.

* Experience with vaccines is preferred.

THE COMPANY

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

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