Title MSAT Project Manager; Rare Diseases

At Recordati, we are united by a clear purpose: unlocking the full potential of life. With a century of history behind us, we are building the next chapter of our journey, continuing to grow while keeping patients at the centre of all we do.

What drives us is a shared belief that health, and the opportunity to live life to the full, should be within reach for everyone. This brings energy to our work, shaping how we support each other and show up every day. Our values – Better Together, Never Settle and Always Deliver – reflect this mindset, helping us to keep improving and make a meaningful difference.

Above all, these values bring to life our promise to everyone at Recordati, you can unlock your full potential. We know that people thrive when they can be themselves, are trusted and supported, and are given the opportunity to grow and make a meaningful contribution.

Are you ready to unlock your full potential?

Recordati Rare Diseases, Inc. (RRD) develops high-impact therapies for devastating rare diseases, focusing on providing often overlooked treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, improved diagnoses, and enhanced treatment availability, covering endocrinology, metabolic, and oncology franchises. RRD is dedicated to excellence, fostering a dynamic work environment that promotes professional growth and a significant impact on patients' lives.

Reports To:

MSAT Director
Direct Reports:
None
Areas Managed: MSAT / Biologics Technology Transfer and Lifecycle Management

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 CDMOs and partners.

Secondary: Additionally, the role provides support for life cycle management of Recordati's biological antibody products across multiple phases of development and therapeutic areas.

This role will involve working with global teams and external third-party networks. This 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. The role provides the opportunity 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 may present opportunities to take principal responsibility for individual projects and activities.

As the successful candidate will be working with globally located CDMOs and partners, occasional travel may be required.

Technology Transfer

• Lead technology transfer projects on behalf of Recordati, providing guidance and technical expertise to support operational technology transfer activities at CDMOs 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 and 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.

• Review 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 stakeholders.

• Inform and manage strategies for process characterisation/validation.

• Provide technical input into solution resolution for…