Johnson & Johnson Loopbaan
Head of Drug Product Manufacturing
Requisition ID: 1805645744W
Janssen Vaccines & Prevention, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. Our teams focus on the discovery, development, manufacture and marketing of vaccines to protect people worldwide from infectious diseases. We have built a dedicated, world-class, multi-functional team across a variety of disciplines to develop a promising vaccines pipeline. In Leiden, we have a workforce of 700 scientists and support staff. 45% of our employees has a nationality other than Dutch, with over 20 nationalities represented. We partner with many of the world’s leading experts, academic and clinical institutions and other pharmaceutical companies for the development of vaccines against, for example, Ebola and HIV.
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 Janssen. The offices of Janssen Vaccines & Prevention are located in Leiden, The Netherlands.
We are currently recruiting for a Head of Drug Product manufacturing.
The Drug Product Development (DPD) department consists of five teams that work closely together: Formulation Development (FD), Formulation Science & Technology (FST), Technical Integrators (TI) and Fill/Finish Process consisting of Process Development (PD) and Manufacturing. 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 with the clinical (supply) teams to define the storage and distribution network, and to generate in-use stability data.
We are looking for an expert in aseptic drug product manufacturing. As Head of Drug Product manufacturing you will lead the manufacturing (outsourcing) team and be responsible on an operational level for the aseptic fill/finish manufacturing of investigational vaccine drug products. The main responsibility is to ensure proper and timely execution of outsourced manufacturing activities as defined in SOWs, in compliance with applicable quality and regulatory standards. You will play a significant role in managing the outsource partners, which will require travelling up to 20% of your time.
You will be a member of the Drug Product Development leadership team and participate in various corporate governance bodies. Furthermore, you will be registered with the Dutch Health Care Inspectorate (IGZ) as the formal Head of Production for drug products.
- Responsible for the well performance and motivation of the Fill/Finish manufacturing team.
- Identifies CMOs capable of supporting the requirements for the manufacturing of DP.
- Ensures available capacity at CMOs for ongoing and future projects.
- Supports and participates in discussions regarding the contracts such as Non-Disclosure Agreement and the Master Service Agreement (MSA) with the CMO and JVL Procurement
- Ensures that CMOs are being qualified by QA and that a quality agreement is in place prior to any GMP activities.
- Ensures that the (Sr) FFP Specialists are trained and appropriately supported during their on-site CMO visit.
- Coordinates non-project related activities at CMO and has general oversight.
- Is accountable for producing the agreed material within the defined timelines and budget, meeting the agreed quality requirements.
- Assures continued qualified / operational status of CMO.
- Tracks overall performance of CMO.
- Reviews SoWs for consistency across projects.
- Responsible for internal and external stakeholder management.
Specific professional/technical requirements
MSc/BSc in relevant discipline, like pharmaceutical sciences, pharmacy, (bio)chemistry or other life sciences or engineering. At least 5 to 8 years of (hands on) experience in aseptic fill/finish GMP manufacturing of (bio)pharmaceuticals, preferably supplemented with experience as a line manager. In depth knowledge of applicable quality guidelines, regulatory guidelines and industry standards is expected, including those covering external manufacturing.
In-depth understanding of Drug Product GMP manufacturing of vaccines and/or large molecules, including relevant unit operations, equipment and facility design and validation, as well as applicable quality and regulatory guidelines.
At least 10 years of experience in vaccine and/or large molecule process manufacturing. Experience with the following is a requirement: life cycle process validation technology transfers, GMP manufacturing, outsourcing, troubleshooting, conducting audits and due diligence visits. Broad experience in applicable quality, regulatory, technical and business aspects. Familiarity with outsourcing and QbD in a manufacturing context will be strong advantages, as is experience with the development of aseptic processes.
The candidate fit for the job is collaborative, enjoys working in a team, pro-active and flexible. Business acumen, a strong quality mindset, as well as excellent organizational and communication skills are key for this position. The candidate can travel frequently (20%).
As an employee, you are our most valuable asset. We take your career seriously. As a member of a global team in an innovative environment, your development is key and is our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth. Our benefits make sure we care for you and your family now and in the future.
Janssen Vaccines & Prevention BV (8852)