As technical integrator, you will lead the DPD project team and represents the team in the CMC project team. You coordinate the departmental deliverables for 2-3 CMC projects in alignment with DPD line management as well as with other functional areas, like Analytical Development, Drug ...
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, <STRONG>Janssen Vaccines & Prevention</STRONG>, we are searching for a Technical Integrator Drug Product Development.
Janssen Vaccines & Prevention is dedicated to bringing meaningful innovation to global health. They focus on the discovery, development, manufacturing and marketing of vaccines and antibodies to protect people world-wide from infectious diseases.
The Drug Product Development (DPD) department consists of the Formulation Development (FD) and the Fill/Finish Process (FFP) teams. The DPD department develops the bulk drug substance and drug product formulations, the aseptic compounding and fill/finish processes, and oversees DP manufacturing at fill/finish sites within and outside Janssen. The department is embedded in the broader Vaccine Process & Analytical Development (VPAD) organization and collaborates for instance with the clinical (supply) teams to define the storage and distribution network, and to generate in-use stability data.
As technical integrator, you will lead the DPD project team and represents the team in the CMC project team. You coordinate the departmental deliverables for 2-3 CMC projects in alignment with DPD line management as well as with other functional areas, like Analytical Development, Drug Substance Development, Regulatory Affairs, Quality Assurance and Clinical Supply Chain.
- Represents the DPD department on the CMC project team, acting as a single point of contact for the CMC team leader;
- Lead a functional sub-team containing DPD representatives and Subject Matter Experts (SME) and is responsible for the planning and execution of DPD project deliverables;
- Develop the project strategy in consultation with the DPD department and CMC team in line with project targets;
- Drive partnership and collaboration between the functions and ensures that the customer (internal & external) requirements are well understood by their teams and are used as main drivers for development;
- Budget preparation and alignment within DPD;
- Generation of appropriate risk management scenarios;
- Ensure that adequate technical review of regulatory submissions has taken place by the appropriate SME and ensures consistency in content across submissions.
Who we're looking for
The ideal candidate has a PhD in pharmaceutical sciences, pharmacy, (bio)chemistry or other life sciences. You have at least 5 years pharmaceutical industry experience, preferably in a biopharmaceutical drug development environment. Experience with vaccines is preferred. We are looking for a candidate with proven technical expertise in at least one of the functional areas (DS, DP and Analytics), a broad knowledge of the pharmaceutical industry and knowledge of functions involved in drug development/commercialization process. GMP and regulatory process experience is required.
As a person you have the ability to lead and develop multidisciplinary teams. You are pro-active and have a supportive attitude.
Additional vacancy information
Contract: Temporary contract with CLS Services
Terms: Fixed-term assignment for 6 months. Full time preferred, 32 hours discussable.
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555
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