Manager RD
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Job Location:
Schaffhausen - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .
As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
R&D Product DevelopmentJob Sub Function:
R&D Process EngineeringJob Category:
People LeaderAll Job Posting Locations:
Schaffhausen SwitzerlandJob Description:
The Schaffhausen Fill & Finish Pilot Plant (F2P2) manufactures parenteral biologics and device assembly products for clinical trials and supports technology transfer to commercial manufacturing. Johnson & Johnsons Clinical Manufacturing & Technology team is seeking a Facility Start Up Manager based in Schaffhausen Switzerland.
The Facility Start-Up Manager will ensure operational readiness by managing the start-up of expanded clinical manufacturing zones and overseeing upgrades to existing production areas until they are handed over to routine clinical operations. He/She will technically lead the start-up project team in a matrix organization and ensure that facilities and equipment meet sterile and device assembly production requirements establish operational flows and ensure compliance with GMP J&J/site policies and Annex 1. The Facility Start Up Manager will ensure new equipment and processes are aligned with the commercial facility and maintain continuous harmonization between both to enable seamless scale-out and technical transfers. Following handover the Manager will retain a leadership role in the area.
Main responsibilities include the following:
Technical lead of a cross-functional team
Responsible to ensure operational readiness of pilot plant
Development of an operational flow with hand-over to production team
Ensure technological alignment and site harmonization or seamless scaleout and BCP readiness.
Ensure EHS compliance and employee safety across all project stages - mitigate hazards coordinate with EHS and embed safety into operations.
Support qualification requirements and responsible for validation of new facility processes and equipment
Provide design input to engineering projects to ensure technical solutions meet production needs
Collaborate with extended site stake holders to ensure supporting processes are in place and staffed sufficiently
Create capacity plan for new facility in support of global production planning
Define operating model and training approach for production personnel and assure timely implementation
Define and ensure availability of all new process materials and consumables in coordination with Supply Chain.
Responsible for establishing all required GMP documentation
Responsibility for successful aseptic process simulation with hand-over to operational team
For this position we are looking for an experienced professional with working experience in a highly regulated environment (FDA/J&J standards and guidelines general GMP guidelines) project management effective communication leadership and excellent interpersonal skills to build a reliable network within a matrix organization.
The following hard skills are required:
Masters degree in engineering or scientific discipline (e.g. Bioprocess Chemical Mechanical Biotechnology Pharmaceutics).
At least 5-7 years of professional experience in related activities in the healthcare industry
Excellent technical understanding of aseptic filling technologies and processes
Production experience within a GMP regulated environment (pharmaceutical preferred)
Excellent interpersonal skills
Change management skills
People leadership experience
Project leadership experience
Excellent analytical skills communication strength empathy assertiveness and high customer and business orientation.
Very good level of German and English both spoken and written.
Required Skills:
Preferred Skills:
Agile Decision Making Crisis Management Developing Others Disruptive Innovations Emerging Technologies Engineering Inclusive Leadership Leadership Process Control Product Costing Program Management Project Schedule Quality Assurance (QA) Representing Research and Development SAP Product Lifecycle Management Team Management Technical Research Training PeopleRequired Experience:
Manager
Key Skills
- Restaurant Experience
- Customer Service
- Employee Evaluation
- Management Experience
- Math
- Employment & Labor Law
- Sanitation
- Leadership Experience
- P&L Management
- Mentoring
- Supervising Experience
- Restaurant Management
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
