Associated Director F2P2 Operations

Janssen Research and Development, LLC, a member of the Johnson and Johnson Family of Companies, develops treatments that improve the health and lifestyle of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders and reproductive medicine.

For the Discovery, Product Development & Supply(DPDS) Department located in Schaffhausen, Switzerland we are looking for a

Associate Director F2P2 Operation (m/f)

The Associate Director will be responsible for the plant readiness and on-time delivery of biological drug product and combination product for pre-clinical, clinical and commercial supplies manufactured in the fill finish pilot plant (F2P2) within the Drug Product Development and Delivery Organization .

She/He is responsible to keep the plant up to date with cGMP standards and represents the production department in internal and external audits and cross-functional teams.

The Associate Director will be responsible for the day to day operation of the parenteral fill finish pilot plant in a two-shift regime to support the operational execution of the master production schedule.

The product portfolio includes clinical, launch and commercial drug product supply as part of the larger supply organization.

Integral to the role is leading supervisors and production team in flex shift pattern with focus on oversight and execution to assure adherence to plan and to reliably meet demand for clinical material as well as implementation of lean process improvements necessary to advance drug product introduction and commercialization.

The function holder will work across the global DPDS and Janssen Supply Chain organization to deliver the parenteral portfolio with the right first time approach.

Main responsibilities include the following:

• Leading and coordination (planning, resources, cost) of the production team in DPDS F2P2 working in 2-shift set up
• Leading and supervision of the team leaders and the overall production team
• Define supervisor objectives, translate them into activities and take responsibility for the team performance
• Coaching and mentoring of the team leaders
• Personal management
• Planning and coordination of plant operation
• Accountable for adherence to production plan in alignment with Global Planning
• Accountable for production budget and budget’s adherence for the production facility
• Responsible for supply of pre-clinical, clinical and commercial material according to EHS and regulatory requirements
• Assure facility & production maintenance is executed on time to keep facility readiness
• Assure adherence to GMP & GLP regulations and continuously improve cGMP compliance in close cooperation with quality organizations
• Inspection representative as subject matter expert for DPDS F2P2 with responsibility for internal and external audit readiness
• Owner of the production performance indicators
• Joint responsibility to manage and support qualification, review and validation tasks
• Responsible for the quality of supplies and electronic batch records to meet the agreed quality standards
• Documentation management (batch records, protocols, reports, SOPs, event/deviation).
• Support of the implementation of new NPI in DPDS F2P2.
• Collaboration with other departments across DPDS, Janssen Pharmaceuticals and J&J to assure reliable clinical and commercial supply
• Support of LEAN implementation and continuous improvement projects
• Support in EHS and Compliance audits as Sub-system owner according to SPOC.
• Assist with the execution of the EHS Integrated Ownership of Safety Systems program list and to act as a coordinator for program relevant activities within their department
• Pilot plant representative in global and cross functional scientific project teams
• Provide technology transfer support (internal and external)

For this responsible position we are looking for a professional with working experience in a highly regulated environment (FDA/EMEA/Swissmedic/J&J standards and guidelines, general GMP guidelines), effective communication, leadership and interdependent partnering skills to be able to build an excellent internal and external network of development and production specialists.