SVP Head of Cell Therapy GMP Manufacturing Process Development all genders

Senior Vice President (SVP) Head of Cell Therapy GMP Manufacturing & Process Development (all genders)

Location: Modena Italy

For our Cell Therapy Manufacturing Site in Modena we are seeking a highly motivated and experienced leader to join our team as:

SVP Head of Cell Therapy GMP Manufacturing & Process Development (all genders)

This role is part of the global leadership team and is responsible for overseeing internal and external cell therapy projects as well as driving the growth and development of the Modena Cell Factory to meet strategic business needs.

The SVP will ensure the successful transfer and GMPcompliant manufacturing of cell and gene therapies while also taking ownership of logistics and supply chain management. Additionally the role supports collaborationsboth internal and externalfor manufacturing activities and champions the expansion and innovation of our manufacturing capabilities and technologies.

The SVP plays a key role in supporting business development strategic partnerships and planning efforts for standalone manufacturing as well as integrated development programs.

About the Cell Therapy Business at Evotec

iPSCbased Cell Therapy is a pioneering focus area within Evotec marked by significant growth and a strategic ambition to lead the market. We invest in cuttingedge technology platforms and generate discoverystage projects to attract partners and drive progress. Our collaborators include leading international pharmaceutical and biotech companies.

The global Cell Therapy Business Unit is fully integrated into Evotecs innovation and drug development structure advancing partnered projects to IND and clinical stages. Core teams are located in Gttingen Germany (Research & Process Development) and Modena Italy (Process Development QC Regulatory Affairs and GMP Manufacturing) with additional support from Evotecs global network of sites.

Our Modena site is a recent addition to the Evotec group equipped with a stateoftheart Cell Factory certified by AIFA (Italian Medicines Agency). The team comprises highly skilled professionals with strong backgrounds in cell therapy development. With opportunities for significant expansion the Modena site plays a key role in Evotecs strategic partnerships and CDMO service offerings.

Your Profile

We are seeking a cell therapy expert with a vision to bring innovative treatments to patients. Candidates should bring deep expertise in cell therapy manufacturing and development with a proven track record spanning earlystage projects through late clinical or commercial production. Strong leadership strategic thinking and team management capabilities are essential.

Key Responsibilities

• Lead the Modena site and operational team overseeing process development GMP manufacturing QA and QC functions

• Ensure compliance with timelines and budget requirements

• Drive operational efficiency cost optimization and continuous improvement

• Oversee the transition from development to GMPcompliant manufacturing

• Ensure implementation and optimization of logistics and supply chain processes

• Guarantee compliance with EUGMP and other relevant regulatory guidelines

• Uphold pharmaceutical standards in accordance with national and international regulations

• Represent the site during audits and inspections

• Contribute to the business plan and strategic positioning of the Modena site

• Support CDMO discussions and strategic partnerships

• Lead team development and foster a highperformance culture

• Integrate innovation into cell therapy manufacturing strategies

• Guide the development of facilities to meet strategic and client needs

• Serve as a key contact for internal and external GMP transition and manufacturing projects

• Collaborate closely with leadership in Modena Gttingen Verona and across Evotecs global sites

• Represent the site at conferences industry meetings and networking events to increase visibility

Qualifications and Experience

• PhD or equivalent in pharmacology medicine biology or a related scientific discipline

• Minimum 10 years experience in the cell therapy sector with a strong track record in ATMP manufacturing from development to GMP production

• Experience spanning earlystage through late clinical manufacturing; commercial manufacturing experience is a plus

• Previous experience in the pharmaceutical industry or a CDMO environment is highly desirable

• Familiarity with clinical trial design is a plus

• Solid understanding of EUGMP regulations; FDA experience is beneficial but EU manufacturing expertise is essential

• Proven leadership experience managing senior scientists and/or group leaders

• Excellent communication skills and a collaborative leadership style

• Structured handson approach with a passion for science and manufacturing translation

• Strong personal motivation flexibility and high energy

• Ability to work crossfunctionally and across cultures within a global organization

• Fluent in English (written and spoken); knowledge of Italian is an advantage but not required

If you are a forwardthinking leader with a passion for advancing cell therapies and building highperforming teams we encourage you to apply and help us shape the future of cell therapy manufacturing at Evotec.

FR : Dans le cadre de sa politique Diversit Evotec tudie comptences gales toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy Evotec considers with equal competences all applications including people with disabilities.