Johnson & Johnson Careers
Director - Department Head BioTD-AD
Requisition ID: 1805694666W
Johnson & Johnson, through its operating
companies, is the world's most comprehensive and broadly based manufacturer of
health care products, as well as a provider of related services, for the
consumer, pharmaceutical, and medical devices and diagnostics markets. We
strive to provide scientifically sound, high quality products and services to
help heal, cure disease and improve the quality of life.
Janssen is a successful international development and manufacturing facility in the pharmaceutical sector of Johnson & Johnson, located in Schaffhausen, Switzerland. At our Schaffhausen site, 90 people work for the global Janssen Research & Development organization developing innovative treatments that improve the health and lifestyles of people worldwide.
Within the global Biotherapeutics Analytical Development organization in Schaffhausen we are hiring a
Director Department Head Analytical Development.
In this function, you provide managerial and technical guidance as well as future direction of the department with 30+ employees in a global environment with emphasis on the local drug product manufacturing site. Four centers of excellence with focus on combination product analytics, particle counting and identification, container closure integrity and analytical support for pilot plants generate unique and highly specialized value to the global R&D functions and to the local site. The department is an end-to-end organization which covers the entire life-cycle of analytical procedures, analytical support of development studies as well as clinical and pre-clinical material manufactured at the pilot plants. In addition, you are responsible for leading complex and time critical investigations as well as patient complaints from clinical trials and commercial markets.
- Manage resources and priorities to meet project and business timelines with speed, quality and agility
- Build and maintain a strong partnership with the following R&D groups: primary container and device, drug product development, clinical supply chain, CM&C teams and regulatory affairs
- Liaise with key stakeholders within the local commercial Janssen supply chain including quality control and assurance, parenteral drug product manufacturing and technical operations
- Represent the department at the global Biotherapeutics Analytical Development senior leadership team and at the local R&D leadership team
- Act as single point of contact during Health Authority inspections and respond to internal and external audit observations and requests
- Foster a culture of diversity and inclusion and support individual people development
- Establish and maintain a strong network with external universities and partners to maximize output of the department through effective and efficient collaboration
- Initiate and lead discussions to identify new scientific and technical opportunities and set strategic direction based on future needs
- Ensure adherence to regulatory guidance documents, cGMP, safety and business guidelines
- Ensure adherence to operational, capital and project budget plans
- At least 10 years relevant experience in biopharmaceutical development, licensure and post-marketing support is required
- Ph.D. in Biochemistry, Analytical Chemistry or related discipline is required
- Proven track record in leading scientific teams including strong people leader skills in a diverse and inclusive environment
- Strong communication skills at all levels in a global set-up
- Proven track record of strong external network within the pharmaceutical industry and universities to maximize output and impact for the global organization
- Ability to challenge the status quo and to drive innovation, high throughput analytics and automation in analytical development
- In-depth experience in large molecule analytics, as well as substantial knowledge in other CMC functional areas such as drug product development, combination products as well as fill and finish operation
- Broad knowledge in the biopharmaceutical industry, including analytics and manufacturing operations in drug products, combination products and life cycle management of the portfolio
- Experience in device analytics and relevant guidelines
Primary location: Switzerland – Schaffhausen
We are offering you a multifaceted opportunity in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructure.
If you are interested in this exciting position, please apply online at www.careers.jnj.com (including application letter, CV and testimonials).
Cilag GmbH International (8525)