Device Lead

**Date**: Feb 22, 2024
**Department**: GTD Global Technical Development

**Job Type**: Direct Employee
**Team**: R&D, Pharmacovigilance & Regulatory Affairs
**Contract Type**: Permanent

**Location**:
Parma, IT

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more here

We are proud to have been awarded with B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.

We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.

We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi Research & Development

Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, chemical manufacturing and controls, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden) and Toronto (Canada).

Who we are looking for

Purpose

The scope of the role is to manage and lead all technical aspects of either device or Drug Delivery Device design and development - from product concept through to a fully commercialised product

Main Responsibilities
- Working in accordance with company quality, cGMP, device related, HSE requirements and regulations - support SOP preparation where required
- Represent DEV DEV department in ETT and in Core teams (following GTD, R&D and company governance)
- Leading and delivering large technical work programs with a cross-functional team from feasibility to ultimate manufacture
- Device Technical project management including definition of device activities, workload, timelines and costs
- Accountable for all aspects of the device development process, including the packaging, (e.g. design input, design, testing, verification,output and device manufacturing process validation)
- Conduct technical reviews during the development of new products
- Author, review and approve development documentation where required and in line with internal SOPs - Support the creation and management of the DHF
- Identification and evaluation of external partners (Design Consultants / Specialist test consultants / manufacturers) where required in collaboration with relevant QA and OM/procurement
- Responsible to Plan, monitor and document activities (e.g. protocols and reports) for the development, DVT, stability and characterisation studies of packaging materials and devices (Study monitor)
- Supporting internal and external teams according to internal SOPs for OOS, deviation, investigations, CAPA, changes related to products/processes in development or already existing
- Run technical due diligence and technology landscaping analyses
- Actively participate in usability, design and process risk analyses to identify and assess risks and to define, implement and verify effectiveness of risks mitigations and controls
- Responsible to develop and validate device manufacturing lines to be used for R&D purposes (e.g. prototypes, clinical trial, etc) and for product launch/submission
- Collaborate in the development and validation of new test method applicable to device constituents parts
- Technology Transfer - manage the transfer of all device specifications (including test methods), design, manufacturing and development history documentation from R&D to GMD
- Support the preparation of documentation for regulatory submissions (for clinical and market approval) in accordance with requirements and guidelines
- Technical support to writing of Quality Agreements, Supply and licencing agreements with external suppliers or partners
- Attend meetings with regulatory bodies and/or audits
- Ensure the respect of the safety and environmental rules and regulations, acting as "Preposto" according to D.Lgs 81/08

Experience