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The Position

Pharma Technical Operations (PT) is responsible for manufacturing, supply chain, and quality across the pharmaceutical network. Within PT, PTT (MSAT & Engineering) is responsible for ensuring that PT stays at the forefront of technology in our facilities and supports our robust processes & efficient operations. We focus on integrating product health, process health with equipment fit for purpose, and facility readiness in support of the manufacturing network.

Global Device, Packaging and Distribution MSAT ensures our device-related products including platforms and packaging systems are robustly engineered, efficiently manufactured, and safely delivered and maintained.

We are seeking a highly skilled Primary Packaging expert to lead the integration of primary container closure systems for our next generation of drug delivery devices.

The Opportunity

In this role, you are the technical lead for prefilled syringes (PFS) and cartridge based container closure systems (CCS), ensuring seamless integration with autoinjectors and needle safety systems.

• You bridge the gap between formulation requirements and mechanical device performance to deliver safe, effective, and patient-centric injectable based combination products

• You provide CCS technical expertise and strategic guidance working collaboratively with experts in global multi-functional teams from early development through to product launch, technical commercial support and life cycle management

• Close cooperation and cross-functional interaction with Technical Development Teams, Regulatory, Manufacturing Science & Technology (MSAT), Operations, CMO’s, Quality, Suppliers and other involved stakeholders.

• Partner with platform device teams to ensure that system-level requirements for combination products are meticulously developed, verified, and validated in alignment with design control

• Support continuity of supply for marketed products and ensure technical performance, processability and safety of the primary packaging components and systems

• Lead CCS related technical impact assessment for investigations, complaints and change control

• Contribute to safety assessments of material of construction of components and container closure systems and provide technical expertise to the network for trouble-shooting primary packaging related issues including component defects, drug product manufacturing process and inspection.

Who you are

You have strong leadership and communication skills, demonstrated through the successful establishment and management of cross-functional teams in a manufacturing setting. You bring the following qualifications:

• M.Sc. or Diploma (and 10+ years) or PhD degree (and 6+ years) in Parenteral manufacturing, Parenteral process development, Container closure and combination product development, Product Quality, Analytical, Material Sciences, or related fields in the pharma/biotech/medical device industry.

• Provide technical leadership and expertise to the network, including consultation to senior leaders on primary packaging topics across various modalities of prefilled syringes and cartridges for use with needle based injection systems such as autoinjector, needle safety devices and pen injectors.

• Expert knowledge and practical experience in container closure systems, e.g. profound knowledge in Aseptic processing, CCS materials, E&L concepts, functional CCS characterization, Container Closure Integrity testing.

• Profound knowledge of quality and regulatory requirements for container closure systems for parenteral pharmaceutical and biopharmaceutical products, primary packaging materials and drug/device combinations products.

• Practical experience and strong knowledge of Parenteral Fill finish processes is preferred and solid understanding of pharmaceutical development in a cGMP environment.

Ready to take the next step? We'd love to hear from you. Apply now to explore this exciting opportunity!

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.