Technical Integrator Drug Substance Development

TECHNICAL INTEGRATOR DRUG SUBSTANCE DEVELOPMENT - LEIDEN, NETHERLANDS - 6 MONTHS CONTRACT - UP TO 55 EUR (PER HOUR)

We are currently recruiting for a Technical Integrator Drug Substance Development

The Drug Substance Development (DSD) department consists of six teams that work closely together: Upstream process development, Downstream process development, Pilot Plant, Vaccine Launch Facility, Engineering/Validation/Maintenance and Technical Integrators. The DSD department develops the bulk drug substance production processes for clinical and commercial manufacturing, produces clinical trial materials, and oversees drug substance manufacturing at GMP facilities outside Janssen. The department is Embedded in the broader Vaccine Process & Analytical Development (VPAD) organization and collaborates with other Janssen departments to perform process scale-up.

JOB DESCRIPTION

The individual leads a DSD project team and represents the team in the CMC project team. The Technical Integrator coordinates the departmental deliverables for 1-3 CMC projects in alignment with DSD line management as well as with other functional areas, like Analytical Development, Drug Product Development, Regulatory Affairs, Quality Assurance and Clinical Supply Chain.

KEY RESPONSIBILITIES

- Represents the DSD department on the CMC project team, acting as a single point of contact for the CMC team leader
- Leads a functional sub-team containing DSD representatives and Subject Matter Experts (SME) and is responsible for the planning and execution of DSD project deliverables
- Develops the project strategy in consultation with the DSD department and CMC team, in line with project targets, while ensuring alignment across the organization
- Drives 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
- Responsible for budget preparation and alignment within DSD
- Responsible for the generation of appropriate risk management scenarios
- Responsible for ensuring that adequate technical review of regulatory submissions is taking place by the appropriate SME and ensures consistency in content across submissions.
- Empowering team members to act with speed, agility, and accountability
- Managing interface with other groups
- Delivering of DSD project deliverables
- Adherence to functional strategies of the line
- Timely escalation of conflicts affecting ability to meet project deliverables

QUALIFICATIONS & SPECIFIC KNOWLEDGE

- Education: PhD or MSc in relevant discipline, like pharmaceutical sciences, engineering, (bio)chemistry or other life sciences.
- Proven technical expertise in Drug Substance process development, broad knowledge of the pharmaceutical industry and knowledge of functions involved in drug development/commercialization process, GMP and regulatory process experience is required. -
- Experience with vaccines
- Relevant experience in pharmaceutical industry, preferably in a biopharmaceutical drug development environment.

JOHNSON & JOHNSON IS AN AMERICAN MULTINATIONAL MEDICAL DEVICES, PHARMACEUTICAL AND CONSUMER PACKAGED GOODS MANUFACTURER FOUNDED IN 1886.

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