Job Description The job that makes possibilities real in patients' lives. And yours. The job that helps you get ahead in life. Moving mountains together. Welcome to AbbVie As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place Moving mountains together – as Principal / Senior / Project Manager, Combination Products & Medical Devices (all genders) (24 months temporary / full-time) Responsibilities Represents CDSM activities as a member of the Combination Products and Medical Device CMC and Development Teams. Provides input to CMC and Development Teams to influence Design History File content to ensure most efficient utilization of submission resources. Translates Design History File content into assembly, labelling, packaging and distribution design. Identifies, develops, communicates and tracks project timelines, activities, logistics, and milestones. Authors process FMEA, specifications and assembly instructions together with stakeholders. Establishes capabilities and fosters automation progress related to the assembly of Combination Products and Medical Devices together with CPD, PDS&T, Engineering Department and CSP. Tracks capital investment equipment projects from purchase to beneficial use Responsible together with Combination Products Development (CPD), Product Development Science & Technology (PDS&T) and/or Allergan Aesthetics, with QA and CDSM functions to establish specifications and instructions to assemble, label and pack Combination Products and Medical Devices for submission-relevant non-clinical and/or clinical use. Manages inventory and plans global shipments of Subparts, assembled Combination Products and Medical Devices Responsible for creating appropriate assembly, labeling and packaging work orders in concert with QA, Analytical, Third Party and partners with CPD and PDS&T, to ensure timely availability of supplies. Responsible for manufacturing of Combination Products and Medical Devices in-house or by Third Party Manufacturers for Research and Development. Tracks and evaluates manufacturing data from request to release. Trains all pharmacy operational personnel. Leads troubleshooting and resolves all operational and machine-related issues ensuring that project needs and priorities are understood by team members. Coaches and mentors staff members on supply requirements and topics. Provides input and recommendation to DSMs, Technical Leads and CMC Product Development Directors on project timing and resource requirements. Must be SME in multiple aspects of Combination Products and Medical Devices topics, e.g. Development of Secondary Packaging Materials, Compliance of Label Content with global regulations (e.g. CTR, MDR, CFR), Center of technical Competence related to assembly steps Successfully leads and participates in within function and cross functional process improvement initiatives. Maintains and adheres to applicable Corporate and Divisional Policies and procedures. Responsible and accountable for resolving of all potentially CDSM related issues about product transfer from development to Clinical and/or Commercial Manufacturing together with CDSM, QA, CPD, PDS&T, Allergan Aesthetics, Operations, Third Party Manufacturing Group. Most Senior CSPM within CSM.