MSAT Project Manager
Hemel Hempstead, GB
Job Purpose
Primary: This role will provide technical support and product expertise to the MSAT team to assist with the technology transfer of commercial biologics manufacturing processes from external partners to new external CDMO’s and partners
Secondary: Additionally, the role provides support for life cycle management of the biological antibody products in Recordati’s, across multiple phases of development and therapeutic areas
This role will involve working with the global teams and external third-party networks. This role is an individual contributor role with no line management responsibilities
Reporting to the director of MSAT, this role will allow the successful candidate to be a key player in securing the future supply of key biologics for the treatment of orphan indications and rare diseases. This role gives the successful candidate the ability to grow both technically and personally within a fast-paced, multi-functional environment. It is anticipated that the role will continue to expand and grow in responsibility with the expansion of Recordati’s portfolio of products and is anticipated to present opportunities to take principal responsibility for individual projects and activities.
As the successful candidate will be working with globally located CDMO’s and partners some occasional travel may be required.
Role Requirements
| Key Accountabilities: | Key Activities / Decision Areas: |
| 1. Technology Transfer |
|
| 2. Manufacturing Process |
|
Required Education
- Minimum, degree in a science related field, preferably in a life science discipline
Required Skills and Experience
- Minimum of 5 years industry experience gained in a pharmaceutical related field with exposure to biological products
- Demonstratable experienced working virtually and remotely is desirable.
Quality Systems Requirements
- Maintain an understanding of current GMP maufacturing, regulatory frameworks. Compliance with relevant RRD Pharma working practices and SOPs and relevant country codes and ensuring these standards are met across the organisation
Technical/Professional Expertise
- CMC specific knowledge and a strong understanding of analytical methods, manufacturing, process development, quality control and quality assurance related to biologics
- Experience in technology transfer of GMP biologics manufacturing processes
- Experience in authoring of reports e.g. comparability and regulatory submissions
- Ability to work in a fast-paced environment while retaining a high attention to detail and quality
- Experience in working with and managing third party manufacturing and testing partners
- An understanding of process validation and the regulatory challenges required for the manufacture of commercial products
- Excellent oral and written communication skills in English
- Strong interpersonal, collaborative, problem solving and conflict resolution skills
- Ability to develop solutions to technical and organizational issues to improve performance and productivity.
- Experience of budget management and oversight is an advantage.
Travel required in %
- The role will require travel to third party partners based in Europe and the United States of America. Some international travel will be required from time to time. Total of 30% travel.