Requisition ID: 1905764061W
Head Beerse Clinical Release and Stability Labs
The jobholder is responsible for leading the Small Molecule Clinical Release and Stability (CRS) Lab organization based in Beerse, Belgium.
The jobholder's key responsibilities will be to ensure the day-to-day operations of the Beerse located CRS laboratories with primary focus on:
* Release and Stability testing of clinical trial material (CTM) of compounds in Janssen small molecule pipeline (API, DP and P&L).
* Organize efficient analytical characterization to support API and DP process development.
* Ensuring state of the art lab processes, ensures a well-balanced operational and scientific environment and installs and fosters a culture of continuous improvement.
* Ensuring a cGMP compliant lab environment with a permanent inspection readiness state.
* Effective operational focus on outsourced lab activities
* Responsible for scientific interpretation of CRS small molecule portfolio aspects and as such enabling the right first time development of projects.
* Establishing and maintaining an open communication within Global Analytical Development and with API development, DP development and Clinical Supply Chain.
* Establishing a can do and solution-oriented environment in support of key partners
Aligned with the CRS strategy, as set out by the Head Small Molecule Global CRS, the job holder will set the overall strategy for Clinical Release and Stability and Lab practices in Beerse covering continuous scientific and technology advancement, benchmarking and evolving strategies with respect to clinical release and stability enabling an industry leading CRS/Lab department.
The jobholder is responsible for ensuring that the tools, processes, technologies, equipment, training are in place for optimum CRS/Lab support and that safety-health-environmental and quality-compliance standards, policies and procedures are in place and adhered to.
The job holder will have responsibility for the implementation of the long-term Small Molecule CRS business strategy as defined and agreed with the Head SM Global CRS.
In addition, the job holder will have responsibility for staffing and budgeting for his/her organization.
Major Duties & Responsibilities
Lead the CRS Lab team in Beerse to: deliver clinical release and stability testing of CTM for SM; lead team of project responsibles; and management of the Lab processes for molecules in the small molecule portfolio.
As a member of the SM CRS leadership team, lead the creation of a 'best in class' CRS/Lab Organization in Beerse by developing an innovation framework to support the organization in increasing clinical release and stability plus lab support capabilities for SM Development by embracing emerging technologies & science, fostering innovation and talent transfer within the department as well as creating a continuous improvement culture within the CRS/Lab team in Small Molecule at Beerse.
Responsible for ensuring alignment of the department with the performance management process in addition to ensuring adherence to people management procedures
Responsible for leading and developing a high performing clinical release and stability / Lab team, creating an increasing capability and depth of science with respect to all components of the team.
Develop and deploy strategy on how to best support the CRS team in terms of clinical release and stability, lab support, support for strategic initiatives, CRS product support and other key deliverables
* Owns primary budgetary control for the department and aligns with the strategy of the CRS organization
* Responsible for installing a culture based on state-of-the-art methodologies and practices to create best-in-class teams focusing on increased efficiency, cost optimization, quality and innovation, and the appropriate management of risks within all areas of the CRS team.
Represents CRS on cross-functional Drug Product Development, Pharmaceutical Sciences and Chemistry teams, and actively participates in Functional Scientific Reviews.
Identifying collaboration opportunities and building strategic work-relationships with internal and external partners
* Ph.D in Chemistry (Analytical and / or Organic) or Pharmaceutical Sciences or Equivalent by Experience with Masters Degree in Relevant Area is required
* 6-8 years of related experience is required
* Preferred Knowledge, Skills and Abilities:
* regulatory guidelines
* good understanding of API and DP processes
* stability sciences
* strong experience in compliance (audits, inspections, …)
Janssen Pharmaceutica N.V. (7555)