Project Manager (Process Development/ Manufacturing/Pharma)
Duration: 12 months (Renewable)
Location: Buona Vista
Salary : Up to $4500 depending on experience
- 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.
- 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),
- 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.
- 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
If you possess above relevant skillsets, please send in your updated CV in word format to Apple.email@example.com
Lim Pey Chyi
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579