Technology Transfer Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ams2a

BSP Pharmaceuticals S.p.A is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxitc characteristics for the Pharmaceuticals Industry.

BSP has been at the forefront in the fight agains cancer since 2006.

Innovation is the hallmark of BSP with investments in new technologies and production methods in a high containment plant.

We are one of the most important Contract Development and Manufacturing Organization (CDMOs) for anticancer drugs.

The fight against cancer is ours too.

We are currently looking for a Technology Transfer Specialist - that will mainly ensure:

- Prepare kick-off meetings (e.g., participant presentations, internal kick-off meeting, agenda summary), internal project introduction meetings, and subsequent follow-up meetings.
- Ensure, following the kick-off meeting and receipt of the project's technical information, that the project scope is aligned with the original quotation.
- Become familiar with the Quality Agreement (QAA) and Manufacturing Service Agreement (MSA) applicable to assigned projects and ensure their proper implementation.
- Participate in defining the project process design to ensure continuity and harmonization, from the feasibility study through to final project implementation.
- Collaborate with the Quotation team to assess the costs of new material orders or technical changes, and ensure the introduction of any new components required for manufacturing through direct interaction with suppliers and coordination with the relevant internal departments.
- Generate and issue key project documentation, including: TT Checklist, Gap Analysis, TT Protocol, TT Report, Project Timeline, Action Item List, Project Master File, Project Introduction Change Control, related addenda and work plans, and Bill of Materials (BOM).
- Manage and monitor the key activities of assigned projects, including through monthly reporting, to ensure full alignment between actual progress and agreed timelines.



Participate in resolving critical issues related to technology transfer or manufacturing and coordinate the internal functions involved.
- Oversee the planning, execution, and completion of the Engineering, Feasibility, Optimization, Clinical, and PPQphases, and verify the proper scheduling of batches during the technology transfer process.
- Review project documentation, including, for example: process equipment plans, equipment qualification plans, Process Verification Protocols and Reports, Cleaning Validation Protocols and Reports, Master Batch Records (MBRs), development protocols, and related reports.
- Participate in resolving critical issues related to technology transfer or manufacturing of assigned projects and coordinate the internal functions involved. Participate in the Change Control Board, approve changes related to assigned projects, and ensure the monitoring and closure of CAPAs (Corrective and Preventive Actions).
- Ensure the accurate invoicing of assigned projects based on project progress and the payment schedule defined in the quotation.
- Ensure the proper preparation of information generated during the technology transfer process and its effective handover to the relevant Business Manager.

Main Requirements :

- Bachelor's or Master's degree in a scientific discipline (Engineering, Pharmaceutical Chemistry and Technology (CTF), Chemistry, or Biology).
- English: C1 Level
- Knowledge of pharmaceutical manufacturing processes and production facilities.
- Knowledge of Project Management principles and methodologies.
- Proficiency in the main IT tools and software relevant to the role and project management activities.
- Strong organizational and project management skills.
- Effective interpersonal, communication, and negotiation skills.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is :

35k - 40k

At BSP we believe in an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. We respect the diversity , the different backgrounds and experiences and provide equal opportunity for all.

We are BSP.

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ams2a