AstraZeneca Pharmaceuticals LP

Technical Manager, Devices position available in West Chester, OH. Responsible for the On Market Technical Support to Parenteral Combination Products at West Chester. Sit within the Global Product Development (GPD) organization that is part of Pharmaceutical Technology & Development (PT&D) in Operations. Responsible for the Device Technical support to the commercial Parenteral Combination Products manufactured and/or supported from West Chester. Utilize capabilities for example, but not limited to, documentation practices, quality and regulatory compliance, data integrity, change management & product security. Provision of technical expertise to aid in the resolution of manufacturing/method/formulation issues and complaints (e.g. where advanced forensics required) impacting supply or manufacturability. Provide technical support to component supplier management through Device Supply Team. Provision of technical support in the event of product recall incidents. Development of suitable corrective and preventive actions in support of investigations. Support product supply strategy projects (sourcing, asset transfers, capacity expansion, etc.) and business continuity plans through delivery of the drug product control, manufacturability strategy and product quality risk management activities throughout the lifecycle. Develop, manage and support a prioritized portfolio of project activities, with appropriate demand and supply oversight. Responsible for the technical support during the transfer of established products within sites and to external manufacturing partners including support for equivalency determination as applicable. Lead, assess impact and support complex technical improvements or change activities assuring product performance. Support drug product Product/Process Performance Qualification (PPQ) programs in support of transfer and change activities. Manage product knowledge throughout the lifecycle. Maintain technical knowledge in area of subject matter expertise including up to date advances in new technologies to aid in the improvement of pharmaceutical processes and methods. Provide support for regulatory file authoring, review, license renewals and response to questions and technical input to update Device Sections of Regulatory files. Provide support for defining technical standards impacting commercial products specific to regulatory expectations and good business or quality standards. Act as the Device Technical Lead and Device Responsible Person (DRP) once Parenteral Combination Products have been transferred from Development to Operations for commercialization purposes including initial product launch and subsequent global market launches.  Own Design History File (DHF) and ensure it is maintained and kept up to date. Provide Operations Change Management device technical assessment of proposed changes to ensure device and combination products requirements are met. Accountability for the DHF Technical Transfer and Lifecycle Management and Design Controls of the Autoinjector Combination Product to ensure compliance with FDA CFR 820. Manage all technical changes for the device via Change Control and Design Control Procedures.  Lead complex device development and scale up projects with an external manufacturing partner to achieve launch project targets on time, and to agreed quality standards. Provide technical support for regulatory file authoring, review, new license applications and response to questions. Provide technical input to update device sections of Regulatory files for new market launches.

Position requires a Bachelor’s degree or foreign equivalent in any field of study plus six (6) years of progressively responsible experience in the job offered or as a Device Manager, Lead Packing Technologist, Laboratory Manager, or a related position. Must have six (6) years of progressively responsible experience with all of the following: managing and providing technical support to established on market combination products and medical devices; Drug  and device development and commercialization processes including development, launch and life cycle management; multiple disciplines in Chemistry, Manufacturing, and Controls (CMC) and related functions including Global Product Development (GPD), Operations, Global Supply and Marketing Companies; design verification, component manufacturing technology, assembly, and commercialization of devices; identifying appropriate solutions for management of devices and delivering value to organization; using packaging and device development, analytical, formulation and physical science and global supply chain knowledge to ensure effective end to end change management implementation; implementing principles, applications and management of SHE, cGMP and device standards and legislation; project management, design work and design control procedures, including risk analysis and design reviews; and preparing regulatory documentation. 10% domestic and international travel required. 40 hours per week, Monday-Friday, 9:00-5:00. EOE.

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AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.