Packaging & Device Expert - BTDM

Job description

Job Description

We have created the Biologics Technical Development and Manufacturing (BTDM) unit to support our mission to be the world leader in technical development and manufacturing, making high quality novel biologics and biosimilars that transform patients’ lives.

As the Packaging & Device Expert you will join the Device Development & Commercialization team in BTDM. In this role you will be responsible for the implementation of secondary packaging & assembly processes at CMO production sites for marketed and launch Biosimilars (Drug Product) while guaranteeing high customer service level/SCM and achieving COGs improvements.
In addition you will work together with Drug Product Device & Packaging Development in Schaftenau, Austria to coordinate Tech Transfer activities to TechOps and support clinical supply and responsible to setup secondary packaging and assembly processes for combination products at CMOs production sites as well as providing support internal sites.

Major Accountabilities:

Launch and Development responsibilities related to secondary packaging & device processes:
• Support the organization with the evaluation and selection of new CMOs / in-house sites and provide input on the packaging-relevant technical capabilities of existing CMOs
• Support contract-manufacturing sites (CMOs) with regard to development, qualification and implementation of secondary packaging solutions as well as secondary packaging validation processes
• Manage packaging development project/topics or packaging development sub-projects in global team
• Drive the packaging topics to meet predefined timelines
• Support submission documents for secondary packaging material & device assembly processes
• Evaluate and develop new materials and/or alternative packaging materials, packaging solutions or packaging systems based on product, regulatory, business or technical requirements
• Define the strategy for secondary packaging processes together with cross-functional teams

Commercial and operation responsibilities for secondary packaging & device processes:
• Ensure supply for commercial and launch products focusing on secondary packaging processes together with supply chain
• Support QA activities and implementation of process improvements regarding secondary packaging & device assembly processes (e.g. complaints handling)
• Manage communication and collaboration with all departments (eg. QA/TechOps/SCM meeting)
• Develop and qualify global secondary packaging solutions for sterile products in communication with the Sandoz packaging material group
• Qualification of global packaging solutions in line with the current valid requirements (e.g. Development of test protocols and reports, execute IQ, OQ, and PQ etc.)
• Ensure compliance with international regulations (GMP, SHE, pharmacopoeias, authorities, requirements) and adherence to relevant Novartis Quality Modules, Procedures, Guidelines

Desired profile

Minimum requirements

Education: Bachelor degree or higher in Engineering, preferably in Packaging, Materials Science, or a related field
Languages: Good command of English and German, written and spoken. Additional other languages preferred
Experience:
• Min of 3 years of experience in secondary and packaging development or packaging for clinical or commercial drug products or combination products
• Knowledge of testing methodologies and test standard including, shock, drop and vibration testing, peel force testing, barrier analysis, CCI/Sterile integrity, DIN, ISO, ISTA, USP, FDA, MHRA and ASTM standards for packaging design and validation
• Knowledge of packaging equipment, related to sterile packaging activities (e.g. vials, PFS, devices, aseptic form/fill/seal) and printing systems
• Knowledge of equipment IQ, OQ, and PQ and development of qualification and validation protocols / reports for packaging and device assembly activities
• Knowledge regarding design control, documentation, risk management and processes such as MRD, DIR, FMEA, Design Verification, and URS