07 ago
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BSP Pharmaceuticals
|
Latina
07 ago
BSP Pharmaceuticals
Latina
ppBSP Pharmaceuticals S.p.A is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxitc characteristics for the Pharmaceuticals Industry. /p pBSP has been at the forefront in the fight agains cancer since 2006. /p pInnovation is the hallmark of BSP with investments in new technologies and production methods in a high containment plant. /p pWe are one of the most important Contract Development and Manufacturing Organization (CDMOs) for anticancer drugs. /p pThe fight against cancer is ours too. /p pWe are currently looking for a Technology Transfer Specialist - that will mainly ensure: /p ul liPrepare kick-off meetings (e.g., participant presentations, internal kick-off meeting, agenda summary), internal project introduction meetings, and subsequent follow-up meetings. /li liEnsure, following the kick-off meeting and receipt of the project's technical information, that the project scope is aligned with the original quotation. /li liBecome familiar with the bQuality Agreement (QAA) /b and bManufacturing Service Agreement (MSA) /b applicable to assigned projects and ensure their proper implementation. /li liParticipate in defining the project process design to ensure continuity and harmonization, from the feasibility study through to final project implementation. /li liCollaborate 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.
/li liGenerate and issue key project documentation, including: bTT 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). /b /li liManage 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. /li liOversee the planning, execution, and completion of the bEngineering, Feasibility, Optimization, Clinical, and PPQ /b phases, and verify the proper scheduling of batches during the technology transfer process. /li liReview project documentation, including, for example: process equipment plans, equipment qualification plans, Process Verification Protocols and Reports, Cleaning Validation Protocols and Reports, bMaster Batch Records (MBRs) /b, development protocols, and related reports. /li liParticipate in resolving critical issues related to technology transfer or manufacturing of assigned projects and coordinate the internal functions involved.
Participate in the bChange Control Board /b, approve changes related to assigned projects, and ensure the monitoring and closure of bCAPAs (Corrective and Preventive Actions) /b. /li liEnsure the accurate invoicing of assigned projects based on project progress and the payment schedule defined in the quotation. /li liEnsure the proper preparation of information generated during the technology transfer process and its effective handover to the relevant Business Manager. /li /ul h3Main Requirements : /h3 ul liBachelor's or Master's degree in a scientific discipline (Engineering, Pharmaceutical Chemistry and Technology (CTF), Chemistry, or Biology). /li liEnglish: C1 Level /li liKnowledge of pharmaceutical manufacturing processes and production facilities. /li liKnowledge of Project Management principles and methodologies. /li liProficiency in the main IT tools and software relevant to the role and project management activities. /li liStrong organizational and project management skills. /li liEffective interpersonal, communication, and negotiation skills. /li /ul pActual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is : /p p35k - 40k /p pAt 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. /p pWe are BSP. /p /p #J-18808-Ljbffr
📌 Technology Transfer Specialist (Latina)
🏢 BSP Pharmaceuticals
📍 Latina