Commercialization Packaging & Device Expert

NOVJP/338009

For our Clients in Basel we are looking for Commercialization Packaging & Device Expert for a 6 months contract.

Duration: 2018-02-01 to 2018-07-31

Place:Basel

Workload: 100%

Role Purpose

- Manages Device & Secondary Packaging activities related to transfer and launch for assigned projects.
- Leads BTDM project team for transfer and launch project related to device assembly and secondary packaging processes within the BTDM manufacturing network.
- 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 (Post Approval Commitment) 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 according to current processes and standards (GMP, HSE, Regualtory). Ensures PAI (Pre-Approval Inspection) readiness.
- Is a member of the BTDM (Biologics Technical Development & Manufacturing) Device Development subteam, Validation team and Supply Support team.
- 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.

Ideal Background

- Education (minimum/desirable): PhD, Dipl. Ing. in Mechanical Engineering or Pharmaceutical Technology
- Languages: Fluent in English and local language (German) an advantage

Relevant Experiences:

- Minimum 5 years professional experience in Pharmaceutical Manufacturing (preferably assembly & packaging)/Manufacturing Science and Technology/technical Development in assembly & secondary packaging projects.
- Thorough understanding of product processes and 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 and intercultural skills with ability to work in a global Matrix environment.
- Knowledge in design control, documentation, risk management and processes such as DMR (Device Master Record), DHF (Design History File), pFMEA, Design Verification, and URS (User Requirement Specifications).
- Knowledge of 21 CFR part 210/211, 21 CFR part 4/820 and ISO 13485, ISTA, ASTM and EMA medical device directive.

For further details please contact Beata Arciszewska:
email: (see below)