Job Purpose

 Ensures that pharma process technology projects are carried out with a
consistent approach and on a timely basis in line with the MMD AH strategy,
Global AH Quality strategy as well as applicable regulatory requirements.
 Responsible for product qualifications and technology transfer, process
improvement, and process validation
 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.
 Concentrate his/her activities primarily on the support of Global PTS
projects at external manufacturing sites.

Responsibilities

 Provide project management and/or technical oversight, planning,

coordination and support to drug-product manufacturing sites for projects related
to:API-related changes, including supplier and API-process changes
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
Process and method validation/qualification
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:Stage-gate-process
(R&D-to-CMO) for new products (e.g. CMC-section review),
Transfers,
Change control for drug-products (APIs, excipients, packaging),
Contract manufacturing site technical assessments
Qualification/validation approaches.
 Support of direct knowledge transfers involving CMOs, support of
development of global key technology platforms, technical expertise and MMD
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.

Requirements:
 Degree in Sciences (Engineering, Manufacturing Technology,
Pharmaceutical Technology, or Industrial Chemistry is ideal).
 At least 3 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 3 year Experience in a regulated environment in interdisciplinary
project management, one year of which is in Pharmaceutical technology,
Industrial Chemistry, or Food technology).
 Regulatory background incl. FDA and EMEA requirements or motivated to
acquire this quickly.
 Advanced knowledge of GMP requirements or motivated to acquire this
quickly.
 Experienced in internal business processes and organization.
 Travel requirement: willing to travel to the different MMD production
locations