Technical Project Manager

Job responsibilities:

• Provide project management and/or technical oversight, planning, coordination, and

support to drug-product manufacturing sites for projects related to:
o API-related changes, including supplier and API-process changes
o CMO product transfers, including CMO-CMO, site-CMO and R&D-CMO
o Process Robustness and Product maintenance (e.g. due to regulatory changes)
o life cycle management, technical trouble shooting
o Process and method validation/qualification
o Overarching changes to products or materials.
• 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:
o Stage-gate-process (R&D-to-CMO) for new products (e.g. CMC-section review)
& transfers
o Change control for drug-products (APIs, excipients, packaging),
o Contract manufacturing site technical assessments
o Qualification/validation approaches.
• Support of direct knowledge transfers involving CMOs, support of development of
global key technology platforms, technical expertise and site 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.