Technical Integrator // Senior // DPD // Zuid-Holland, NL

Location: Netherlands

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Zuid-Holland Netherlands.

The Company

Our client is dedicated to bringing meaningful innovation to global health. The teams focus on the discovery, development, manufacture and marketing of vaccines to protect people worldwide from infectious diseases. In our organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are of crucial importance. We are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to the organization. The offices of Janssen Vaccines & Prevention are located in Leiden, The Netherlands.

Role Description

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.

The individual leads the DPD project team and represents the team in the CMC project team. The Technical Integrator coordinates 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.

Responsibilities

- Represents the DPD department on the CMC project team, acting as a single point of contact for the CMC team leader
- Leads a functional sub-team containing DPD representatives and Subject Matter Experts (SME) and is responsible for the planning and execution of DPD project deliverables
- Develops the project strategy in consultation with the DPD 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 DPD
- Responsible for the generation of appropriate risk management scenarios
- Responsible for ensuring that adequate technical review of regulatory submissions has taken 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 DPD project deliverables
- Metrics on HR, Finance, Quality & EHS
- Adequacy of functional strategies as shown in DPD’s ability to handle the CMC product portfolio
- General leadership within DPD group

Requirements

- PhD or MSc in relevant discipline, like pharmaceutical sciences, pharmacy, (bio)chemistry or other life sciences or engineering
- +5 years experience within pharmaceutical industry, preferably in a bio-pharmaceutical drug development environment
- Specific knowledge of DS, DP and Analystics
- Broad knowledge of the pharmaceutical industry
- Knowledge of functions involved in drug development/commercialization process
- GMP and regulatory process experience (required)
- Experience with vaccines (preferred)
- Stakeholder management skills
- Project management skills

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ivo Huijskens.