MSAT Project Manager

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.

• Lead technology transfer projects on behalf of Recordati, providing guidance and technical expertise to support the operational technology transfer activities at CDMO's and partner organisations for long term manufacturing and supply of biological products
• Generate internal reports and review documentation supporting technology transfer (e.g., master plans and reports, process descriptions, detailed gap assessments, as appropriate) ensuring all information is available to key stakeholders in RRD
• Generate options to resolve technical challenges and present them for endorsement
• Capture, trend, and analyse process generated batch data to support process improvements and life cycle management
• Perform review of manufacturing documentation generated by the receiving unit (manufacturing records, batch sheets, study protocols, SOPs, etc.) to ensure accuracy and suitability
• Participate in, and where appropriate lead technical sub-teams
• Drive and maintain project progression with external and internal stake holders
• Inform and manage strategies for process characterisation/ validation
• Provide technical input into solution resolution for commercial processes and analytics, and input into to any unforeseen events by engaging with the correct stake holders to effectively resolve problems as they occur
• Influence decisions, considering different functional department requirements
• Coordinate, control and disseminate the flow of information to and from third parties and to internal stake holders

• Have a demonstrable understanding of biological USP, DSP and Drug Product manufacturing processes (ideally experience in one or more pertinent fields, such as; analytical, validation, shipping and supply chain requirements), technology transfers and CMC regulatory
• The ability to network and develop authentic high performing working relationships will be highly regarded. This will have a requirement of being able to express ideas and activities to a wide type of backgrounds
• The ability to operate strategically ensuring that project progression is performed holistically with the product and patient being central to every decision and action.
• Recordati operates in multiple countries where demonstrable coordination skills across multiple territories with different cultural and ways of working will be required while meeting some demanding timelines.

• Minimum, degree in a science related field, preferably in a life science discipline

• 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.

• 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

• 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.

• 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.