Technology Transfer Project Manager

Eusa Pharma; Spoleto; In loco; EUR 57.000 - 71.000; Tempo pieno

Descrizione del lavoro

EUSA Pharma in Poreta, Italy, seeks a Technology Transfer Project Manager to lead transfer projects for small molecule drug products across internal and external sites. You will coordinate TT master plans, protocols, and validation strategies, ensuring readiness of all manufacturing documentation.

Collaborating with QA, RA, Supply Chain and R&D, you will monitor technical risks, drive cross‑functional execution, and maintain alignment with GMP and regulatory commitments in a fast‑paced

Competenze

• Min.6-7 years' experience in MSAT, Technical Operations, Technology Transfer in pharma.
• Solid understanding of manufacturing processes for solid, semi-solid, sterile and liquid forms.
• Experience managing technology transfer, process validation, and commercial support.

Mansioni

• Lead technology transfer projects for small molecule drug products across sites.
• Coordinate TT master plans, protocols, gap assessments, and validation strategies.
• Support scale‑up, PPQ readiness, and manufacturing documentation.
• Troubleshoot issues and guide decisions with SMEs and CDMOs.
• Ensure alignment with GMP, regulatory commitments, and change control.
• Review and approve batch records, SOPs, and control strategies.
• Analyze data, identify optimization opportunities, and manage KPIs.

Conoscenze

MSAT

Technical Operations

Technology Transfer

GMP knowledge

Process validation

CMOs/CDMOs management

ICH guidelines

Cross-functional collaboration

QA/QA oversight

Change control

Formazione

Degree in Pharmacy

Chemistry

Chemical Engineering

Related scientific discipline

Descrizione del lavoro

Technology Transfer Project Manager EUSA Pharma Poreta, IT

Job PurposeThe TT Project Manager for Small Molecules is responsible for leading and coordinating technical activities related to technology transfer, process industrialization and life‑cycle management of commercial pharmaceutical products (solid, semi-solid, sterile and non‑sterile liquids).The role ensures robust technical oversight of internal and external manufacturing sites (CMOs/CDMOs), supports operational readiness, and enables continuous improvement of manufacturing processes.Working closely with cross-functional teams (QA, RA, Supply Chain, Procurement, R&D,...) the TT Project Manager drives project execution, monitors technical risks, and contributes to securing long‑term supply continuity for Recordati products.This is an individual contributor role with high cross‑functional influence, operating in a dynamic and fast‑paced environment.

Key Responsibilities

• - Lead technology transfer projects for small molecule drug products across internal and external manufacturing sites.
• - Coordinate development, execution, and review of TT master plans, protocols, gap assessments, process descriptions, validation strategies.
• - Support process scale‑up, process performance qualification (PPQ), and readiness of manufacturing documentation.
• - Troubleshoot technical issues, propose solutions, and guide decision‑making with SMEs and CDMOs.
• - Ensure alignment with CMC, regulatory commitments, and change control processes.
• - Provide technical oversight for commercial processes (solid oral dosage forms, semi‑solids, sterile and non‑sterile liquids).
• - Review and approve manufacturing documentation (batch records, SOPs, control strategies).
• - Analyse manufacturing data, trend performance, and identify opportunities for optimization.
• - Support process validation, OOS/OOT investigations, deviation resolution, and CAPA definition when required.
• - Drive cross‑functional teams ensuring timely execution of project deliverables.
• - Coordinate information flow with internal and external stakeholders, ensuring transparency and alignment.
• - Manage timelines, project budget, risks, mitigation plans, KPIs, and reporting to governance bodies.
• - Facilitate collaboration across functions and geographies, fostering strong working relationships.
• - Maintain an understanding of current GMP maufacturing, regulatory frameworks.

Può ottenere maggiori dettagli sulla natura di questa posizione e sui requisiti per i candidati leggendo quanto segue.Compliance with relevant RRD Pharma working practices and SOPs and relevant country codes and ensuring these standards are met across the organisation

Required EducationDegree in Pharmacy, Chemistry, Chemical Engineering or related scientific discipline

Required Skills and Experience

• - Min.6-7 years' experience in MSAT, Technical Operations, Technology Transfer in the pharmaceutical industry.
• - Solid understanding of manufacturing processes for:Solid oral dosage forms (e.G., tablets, capsules)Semisolid forms (creams, ointments)Sterile or non‑sterile liquid forms
• - Experience managing technology transfer, process validation, and commercial manufacturing support.
• - Competence in reviewing technical documentation and scientific/quality evaluations.
• - Strong knowledge of ICH guidelines, GMP regulations, validation principles, and change control.
• - Ability to work under pressure, manage multiple priorities, and operate effectively in cross‑functional settings.
• - Experience with external manufacturing management (CMOs/CDMOs) is a strong plus.
• - Previous experience in Quality Control (QC), Quality Assurance (QA) or CMC will be considered a significant advantage and highly valued.

Required Behaviours and Competencies

• - Strong analytical mindset, problem‑solving capabilities, and decision‑making autonomy.
• - Ability to work with global teams and adapt to different working cultures.
• - High sense of ownership, accountability, and attention to detail.

Required LanguagesFluent English (spoken and written) – mandatory.

SalaryGross Annual Salary starting from: 57.000Please note: The salary indicated in this posting complies with local pay transparency regulations for Italian employment contracts.Final offers will be tailored to the successful candidate's experience, professional expertise, and interview journey, while ensuring internal equity. xysqume At Recordati, we are committed to a comprehensive, fair, and competitive remuneration system; a full overview of yourtotal rewards package will be shared and discussed with you during the recruiting process.

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