For our customer located in Basel/St. Johann/Switzerland we are currently looking for (m/f/d) a Medical Device Development Project Leader
- Type of placement: 6 months, external contract with possible long term extension
- Company: major Pharma company in Basel/St. Johann area
- Salary: please ask us for the exact rate range
- Start: asap
- Duration: intial 6 months + possibility of extension
Manages Device & Secondary Packaging related to transfer and launch activities for assigned projects. Leads BTDM PharmOps, Sandoz Biopharma or ESO project team for transfer and launch project related to device assembly and secondary packaging processes. Liaises efficiently with related global functions, in particular Device Development BTDM, TechOps, Regulatory and Supply Chain. Is responsible for successful launch / transfer of assembly and packaging processes from Development into Commercial operations and for the availability of launch supplies (in time and in required quantities).
- Maximizes project value.
- Provides technical expertise from commercial point of view during device development stages and process commercilization
- Supports Launch Site Decisions at e.g. PAC by providing analysis of technology, capacity, skills by performing interfunctional evaluations. Makes recommendation to PAC for assembly & packaging site selection.
- Manages technical launch activities (process, technology, capacity, recources) for assembly and packaging at involved sites.
- Defines and monitors project scope and timing.
- Assures that all activities are performed acc. To current processes and standards (GMP, HSE, Regualtory). Ensures PAI readiness.
- Is a member of the BTDM Device Development subteam, Validation team and Supply Support team.
- Performes Due Diligence initiatives and deal negotiations for selected in license and out-license projects.
- Act as a manufacturing representative during device development stages (design control)
- Act as a manufacturing representative in the packaging design process for the BTDM product portfolio
- Support site engeneering in defining assembly & packaging equipment design / qualification related to transfer / launch products
Key Performance Indicators
- No delay of milestones - meets agreed launch schedule.
- Adheres to project / CAR costs and time lines.
- Commercial form and SKUs (Stock Keeping Units).
- Competitive TPC and complexity (number of SKUs) based on business case.
- Process robustness based on statistical evaluation.
- No critical observations during internal GMP inspections and pre-approval inspections (PAI).
- Action plans from internal audits implemented; no delays in approvals.
Budget and technical responsibility for product launches and transfers
ca. $3-8 Mio/y (Tech Transfer/launch)
Indirect business of $0.5bn and reputation of BTDM in case of delay in launches
Impact on the organisation
High business impact: delay in launch and critical deviations during external inspections have a significant impact.
- (State the preferred education and experience level)
PhD, Dipl. Ing.. inMechanical Engineering or Pharmaceutical Technology
Fluent in English and local language. Other languages beneficial
- Minimum 10 years experience in manufacturing / manufacturing science and technology / technical development/Quality in assembly & secondary packaging projects
- Thorough understanding of product processesStrong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
- Fundamental understanding of standard device/packaging analytical testing.
- Expert in reviewing and writing technical reports.
- Strong Project management skills, strong communication skills
- Knowledge regarding design control, documentation, risk management and processes such as DMR, DHF, pFMEA, Design Verification, and URS
- 21 CFR part 210/211, 21 CFR part 4/820 and ISO 13485 knowledge, ISTA, ASTM, EMA medical device directive
- Willingness to travel for short and long distance as well as time periods.
- Flexibility in working hours due to globally located projects / manufacturing sites
- Intercultural skills to work in a global environment.
Kindly be informed that our customer is located in Switzerland. Therefore only applications within the EU or candidates holding Swiss work permission are required.
The SymplyVision-Team is looking forward to receiving your application (Word file is highly appreciated).