MSAT Project Manager in Hemel Hempstead

Recordati, originally a family‑run pharmacy in Correggio, Italy, has grown into a global pharmaceutical company listed on the Italian stock exchange, employing over 4,500 people and generating a turnover of more than €2 billion. We develop and commercialise medicines for common and rare diseases across about 150 countries. Our mantra is simple: health and the opportunity to live life to the fullest is a right, not a privilege. At Recordati we reimagine tomorrow with new ideas, technologies and innovations to fight disease.

Job Purpose

• Provide technical support and product expertise to the MSAT team, assisting with the technology transfer of commercial biologics manufacturing processes from external partners to new external CDMO’s and partners.
• Support life‑cycle management of biological antibody products across multiple development phases and therapeutic areas.
• Work 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 be a key player in securing supply of key biologics for orphan indications and rare diseases, offering growth opportunities as Recordati’s portfolio expands.
• Occasional international travel may be required.

Role Requirements

• Key Accountabilities

• Lead technology transfer projects for Recordati, guiding 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, reports, process descriptions, detailed gap assessments), ensuring stakeholders have the information they need.
• Develop 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 from 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 commercial processes and analytics; engage stakeholders to resolve unforeseen events.
• Influence decisions, considering functional department requirements.
• Coordinate, control and disseminate information flow to and from third parties and internal stakeholders.

• Demonstrable understanding of biological USP, DSP and Drug Product manufacturing processes (analytical, validation, shipping and supply chain) and technology transfers.
• Ability to network and develop authentic high‑performing relationships across diverse backgrounds.
• Operate strategically, ensuring project progression is holistic with product and patient central to decisions.
• Coordinate across multiple territories with different cultures while meeting demanding timelines.

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

• Minimum of 5 years industry experience in a pharmaceutical field with exposure to biological products.
• Experience working virtually and remotely is desirable.

• Maintain understanding of current GMP manufacturing, regulatory frameworks and compliance with relevant RRD Pharma working practices, SOPs and country codes.

• CMC knowledge and strong understanding of analytical methods, manufacturing, process development, quality control and assurance related to biologics.
• Experience in technology transfer of GMP biologics manufacturing processes.
• Experience authoring reports (e.g., comparability and regulatory submissions).
• Ability to work in a fast‑paced environment while retaining high attention to detail and quality.
• Experience managing third‑party manufacturing and testing partners.
• Understanding of process validation and regulatory challenges for commercial product manufacture.
• 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 with budget management and oversight is an advantage.

• The role requires travel to third‑party partners in Europe and the United States; total of 30% travel.

At Recordati we believe in people! Inspired by our purpose – unlocking the full potential of life – we are committed to creating a diverse environment and cultivating a culture of inclusion. We are proud to be an equal‑opportunity employer. We recruit, develop and reward without regard to gender, sexual orientation, gender identity, national origin, age, physical or mental ability, race, ethnicity, political or religious belief. If you are looking to join a company where you can try new things, speak openly and be bold, we invite you to apply today.