This position ensures that pharma process technology projects are carried out with a consistent approach and on a timely basis in line with the Global AH Quality strategy as well as applicable regulatory requirements.
The position holder is responsible for and should have experience in product qualifications and technology transfer, process improvement, and process validation
The position holder is able to act as a team leader and can be held responsible for the performance and/or start-up of a new and/or difficult process technology assignment.
The position holder will concentrate his/her activities primarily on the support of Global projects at external manufacturing sites.
Provide project management and/or technical oversight, planning, coordination and support to drug-product manufacturing sites for projects related to

CMO product transfers, including CMO-CMO, site-CMO and R&D-CMO
Process Robustness and Product maintenance (e.g. due to regulatory changes)
life cycle management, technical trouble shooting
Identification, initiation, support and follow up of projects for continuous improvement of manufacturing processes (process robustness initiative) with target to improve efficacy (e.g. reducing off specs and cycle times, Right First time projects) at the manufacturing sites. Projects include

Stage-gate-process (R&D-to-CMO) for new products (e.g. Change control for drug-products (APIs, excipients, packaging),
Contract manufacturing site technical assessments
Support of direct knowledge transfers involving CMOs, support of development of global key technology platforms, technical expertise and its technology network.
Facilitation of communication and interface for manufacturing sites to other global/local departments such as Quality, Supply Chain Management, Regulatory Affairs, Pharma R&D, Global Supplier Management, and CMO Organization.
Support or lead investigation teams established to solve major quality issues occurring with our AH pharma products.
Minimum Undergraduate degree in Sciences (Engineering, Manufacturing Technology, Pharmaceutical Technology, or Industrial Chemistry preferred).
At least 10 years of experience in technology or manufacturing position in a Pharmaceutical, Food manufacturing or Fine chemicals producing company or in extended experience in an academic environment of Pharmaceutical/Chemistry departments.
At least 5-year Experience in a regulated environment in pharmaceutical CMO management.
Regulatory background requirements or motivated to acquire this quickly.
Experienced in internal business processes and organization.
Travel requirement willing to travel to the different production locations (up to 40 % of the time)
Language requirements English (fluent)
Innovation Management - Advanced
Consulting and Process Re-engineering - Advanced
Managing Diversity - Core
Technical Risk Analysis - Advanced
Conflict Management - Advanced
Quality Knowledge - Advanced
Intercultural Management (US, Europe, ROW) - Advanced
Pharmaceutical Technology - Advanced
Regulatory Affairs - Awareness
Adaptability, Adaptability, API Manufacturing, Business Process Creation, Change Controls, Chemical Engineering, CMO Management, Customer-Focused, Data-Driven Decision Making, Drug Product Development, Equipment Qualification, Estimation and Planning, External Manufacturing, Life Cycle Planning, Manufacturing Quality Control, Manufacturing Technologies, Operations Management, Pharmaceutical Manufacturing, Pharmaceutical Process Development, Process Capability Analysis, Process Control Automation, Process Design, Process Implementations, Process Improvements, Process Maturity + 10 more
Please, no phone calls or emails.
Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Hybrid
Shift
Valid Driving License

Associate Tech Director (Engineering Manager)

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