Company Description

Terafront Farmatech is a public-private company dedicated to advancing research and development of innovative, accessible advanced therapies. Founded in 2024 under Spain’s PERTE for Vanguard Health, it unites the Spanish Ministry of Science, Innovation and Universities through CDTI Innvierte with general life-science companies ROVI and Insud Pharma. This partnership combines scientific excellence, industrial capabilities, and institutional support to strengthen Spain’s role in advanced medicine.

Terafront identifies and backs high-potential projects that can translate scientific innovation into therapies with tangible patient benefits, connecting research, industry, and investment. With a global perspective and strong social commitment, the company focuses on expanding access to cutting-edge healthcare and enhancing the international competitiveness of Spain’s life-sciences ecosystem.

Terafront is seeking an experienced Head of CMC & Technical Operations to lead the development and manufacturing strategy for innovative therapies targeting rare diseases. This is a critical leadership appointment within a growing advanced therapies company. The successful candidate will take ownership of the various CMC programs as they transition from an academic development environment into a sponsor-controlled, regulatorily robust manufacturing package supporting late-nonclinical and early clinical development.

The role

Reporting directly to the CEO, the Head of CMC & Technical Operations will lead all CMC and manufacturing activities across DNA, RNA, protein and cell-product components of the different programs.

The role will work closely with internal R&D;, Quality and Regulatory affairs, as well as external CDMO, analytical testing CROs and a co-development partner network.

Key responsibilities

- Lead the CMC in due diligence, gap assessment and technology transfers.
- Develop and maintain the integrated CMC strategy for the various biomolecular products.
- Act as Terafront’s principal technical contact with CDMOs, analytical testing CROs and co-development partners.




- Define and maintain the Quality Target Product Profile, Critical Quality Attributes, critical process parameters and overall control strategy for the various biomolecular products.
- Oversee DNA and RNA construct strategies, raw-material qualification, analytical development, potency testing, release specifications and stability programs.
- Plan and supervise engineering, demonstration and GMP clinical manufacturing campaigns.
- Establish appropriate comparability, change-control and lifecycle-management strategies.
- Lead the preparation and review of the quality sections of the IMPD and other regulatory documentation required for clinical development.
- Ensure that manufacturing, analytical and regulatory activities form one coherent and submission-ready CMC package.
- Manage CMC budgets, timelines, risks, suppliers and CDMO performance.
- Provide clear technical recommendations and progress reporting to the CEO and Board.

Candidate profile

We are looking for a seasoned CMC professional with substantial development-stage experience in gene therapy or other advanced therapy medicinal products.

The ideal candidate will bring:

- Approximately 10 - 15 years of relevant experience in manufacturing of biologics, gene therapy or ATMP (Advance Therapy Medicinal Product) CMC.
- Direct experience with DNA vector development and manufacturing.
- Experience with ex vivo gene - modified cell products, ideally involving various cell types.
- Demonstrated involvement in building relevant sections of CTA/IMPD for first in human clinical trials.
- Experience in regulatory interactions with EMA or FDA pertaining IND submission for an ATMP or biologics.
- Hands-on experience auditing and managing CDMOs, conducting technology transfers,



implementing process development and manufacturing GMP clinical batches.
- Strong understanding of LVV potency, vector copy number, transduction efficiency, replication-competent lentivirus testing, plasmid control and analytical strategy.
- Working knowledge of EU and FDA GMP and regulatory requirements applicable to investigational ATMPs.
- Experience integrating vector and cell-product manufacturing workstreams would be particularly valuable.
- The ability to assess complex technical information, identify critical gaps and translate them into an executable development plan.
- Strong leadership, communication, negotiation and project-management capabilities.
- A pragmatic and entrepreneurial approach suited to a small biotechnology company operating through an external partner network.

What will define success

During the initial stage, success will mean:

- Completing the CMC and manufacturing gap assessment.
- Establishing an effective technology - transfer and governance framework with the program partners.
- Confirming the clinical manufacturing strategy and critical path.
- Aligning the LVV and CD34+ cell-product control strategies.
- Delivering a credible plan for engineering and GMP manufacturing.
- Establishing a regulatorily robust CMC package supporting Phase I CTA readiness.

Why join Terafront?

This is an opportunity to take a central role in building an advanced therapies company and to shape the CMC strategy of potentially transformative treatments for patients with severe rare diseases.

The successful candidate will have significant responsibility, direct access to senior decision-makers and the opportunity to build the technical operations function from its foundations.

Location: Madrid, Spain

Employment model: Full-time

Reporting to: Chief Executive Officer

Interested candidates may apply through LinkedIn or contact us at [email protected] with a CV and a brief description of their relevant ATMP development experience.

Terafront is committed to equal opportunity and welcomes applications from suitably qualified candidates.

📌 Head of CMC & Technical Operations - Advanced Therapies (Madrid)
🏢 Terafront
📍 Madrid