Technical Integrator Drug Product Development
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 ...
WO / MBA
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.
Who we're looking for
- 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.
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