Beschreibung
For our client in Basel we are looking for a Device & Packaging Transfer Team Lead for a 6-month contract.
Job title: Device & Packaging Transfer Team Lead
Duration: ASAP to (extension possible)
Location: Basel
Workload: 100%
Description:
The candidate 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).
Major Accountabilities:
. Maximizes project value
. Provides technical expertise from commercial point of view during device development stages and process commercialization
. Supports Launch Site Decisions at eg 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, resources) 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, Regulatory). Ensures PAI readiness.
. Is a member of the BTDM Device Development subteam, Validation team and Supply Support team.
. Performs 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 engineering in defining assembly & packaging equipment design/qualification related to transfer/launch products
Must haves:
. Education (minimum/desirable): PhD, Dipl. Ing.. in Mechanical Engineering or Pharmaceutical Technology
. Languages: 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 processes. Strong 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 , 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.
For further details please contact:
Anna Undas
(see below)