Astellas is one of the top 20 pharmaceutical companies in the world, employing 16,000 people globally. As a young and forward-thinking company, Astellas is dedicated to improving the lives of people around the world through the introduction of innovative and reliable pharmaceutical products.
(Sr) Technology Manager Contract Manufacturing Job Description
Context of the job:
The Department Contract Manufacturing Management (CMM) is responsible for the delivery of products from Contract Manufacturing Organizations. It is basically the third, virtual, manufacturing site within Astellas Supply Chain and Manufacturing Europe. CMM needs to make sure that these supplies are reliable and ensure stock availability for distribution at the Astellas Affiliates and Licensees, meeting the quality expectations and compliance with applicable GMPs, regulatory requirements and other regulations e.g. safety and environmental. At the same time costs of goods and revenues must be continuously optimized.
The product portfolio in scope of CMM requires appropriate technology maintenance and quality management activities to be performed, coordinating the CMOs and according to the Astellas Quality System and the applicable international guidelines and regulations
Purpose of the job:
The (Sr) Technology Manager Contract Manufacturing:
- Ensures the availability of state-of-the-art and validated analytical methods and production processes at CMOs, esp. by developing, maintaining and improving the technologies needed for the CMM commercial product portfolio.
- Manages complex technology maintenance and technology transfer projects.
- Operates in compliance with the Astellas Global Quality Assurance Manual, the Astellas Global, Regional and CMM SOPs, acting as contact person for the CMOs, for the Licensees and for the Astellas organization, regarding the assigned portfolio of products.
Primary responsibilities and results: - Actively identify the areas of technology and quality improvement of the product portfolio under responsibility;
- Design, plan and coordinate complex technology maintenance projects with the involvement of CMOs, CROs and regulatory functions.
- Coordinate, control, review and report on assigned studies in the field of: development, validation and transfer of analytical methods (CRO to CMO)
- Validation and transfer of manufacturing processes
- Stability studies according to ICH guidelines
- Express technical and quality expertise about the activities performed with/by CMOs in one or more areas of analysis or technology (such as HPLC, dissolution, granulation, coating, aseptic production, sterile production, etc.)
- Maintain a current awareness of trends in technology developments
- Define the technology and validation activities related to the change control process
- Provide CMC input for Regulatory variation documents
- Evaluate quality deviations and failures at CMOs, ensuring sound root cause investigations and appropriate CAPAs.
- According the applicable procedures, escalates all major or critical quality failures to the Astellas Quality functions.
- Review validation protocols and reports, PQRs and Regulatory CTD documents.
- Ensure the knowledge management for the product portfolio under responsibility.
- Evaluate completeness of CRO and/or CMO quotations, delivering all information needed for the maintenance budgeting activity.
- Performs technical due diligence evaluations of candidate new manufacturers.
(Sr) Technology Manager Contract Manufacturing Job Requirements
Education:
- Pharmaceutical degree at MSc level, with a focus on manufacturing
Experience and knowledge: - 3 – 5 years of consolidated experience on pharmaceutical manufacturing processes
- Knowledge of one or more areas of basic technology (such as aseptic production, sterile production, etc)
- 2 – 3 years of project management experience, operating in complex organizations
- Knowledge of EU Pharmaceutical Good Manufacturing Practices
Skills and personality: - Strong influencing and presentation skills
- Business acumen, negotiation skills
- Strong personality with flair and charisma
- Team player, organization- and culture sensitivity
- Intercultural awareness
Is willing to travel (European as well as globally). We are looking for European citizens for this position.
We offer: - A challenging and diversified job
- Good career opportunities
- Inspiring work climate
- Attractive remuneration
(Sr) Technology Manager Contract Manufacturing Application Information
PLEASE NOTE: before applying check if you match for at least 80% percent with the given job requirements (including the summary).
For this position we are looking for European citizens, so only apply if you live and work in Europe.
Interested? Apply with your full Qreer.com profile and CV by the apply button.
(Sr) Technology Manager Contract Manufacturing Summary
| Education Backgrounds: |
Biomedical Science
|
| Specialties: |
Life sciences
Manufacturing
Pharmaceutics
Project Management
|
| Education Level: |
Postgraduate (Masters)
|
| Experience: |
2 - 5 years
|
| Languages spoken: |
English
|
| Job Location: |
Leiderdorp, Netherlands |
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