Our client is a clinical-stage biotech developing CAR-T candidates based on multiple antigens for different oncological indications, and an allogenic platform based on Gamma delta T cells coming from a novel source. The company, a spin-off from an international top-notch leukemia researchcenter, has already raised more than 15 million €€ pre-Series A from VCs as well as non-dilutive funds to advance its pipeline programs.

Main responsibilities:

• Financial Round:
  o Define fundraising strategy for Series A.
• Business development activities:
  o Attendance to partnering events and congresses.
  o Contacts with VCs, pharmas, corporate investors.
  o Deal making, i. e. licensing of specific assets.
• Strategy definition and implementation
  o Clinical strategy.
  o Pipeline extension.
• Execution of the Development plan:
  o Follow-up meetings and review reports from institutions.
  o Negotiate contracts for outsourcing activities.
  o Establishment of a preclinical regulatory roadmap.
  o Budget control and execution.
• Professionalization of the Company.
  o Establishment of a SAB (Scientific Advisory Board).
  o Conduct Board meetings.
  o Reporting to Investors.
  o Team building.
  o Corporate image.

Requirements and skills:

• Previous experience in ATMPs, preferably, cell therapy.
• Leadership of small, high-performance teams in fast-moving environments, at C-level or similar.
• Experience in raising funds from international VCs and corporate investors.
• Experience in raising non-dilutive funds.
• Experience in technology transfer projects from research centers.

We are looking for full-time CEO, ideally with residence in or willingness to relocate to Barcelona; if relocation is not feasible, the CEO is expected to be in
Barcelona on an as-needed basis, at least 1-2 weeks per month.

Our client is a biotech company, backed by top tier national and international VC's, with a disruptive platform technology. The Operations Manager will be the right hand of the CEO, a multifunctional Project Manager with a strong focus on analysis of business opportunities, funding and BD activities. This position is based in Barcelona.

Main Responsibilities:

• Responsible for creating and maintaining integrated project development plans and timelines, for tracking and reporting progress, and for preparing project related presentations, reports, and documents. Monitor market trends, competitive landscape, and regulatory developments,
  company profile to identify new opportunities and support internal projects.
• Support the development of the overall business strategy, ensuring alignment with the company's vision and objectives.
• Prepare relevant BD documents such as project dossiers, executive summaries, and presentations.
• Support non-dilutive funding activities.
• Support contract negotiations with third parties

Required Qualifications & Experience:

• Degree in Life Science. MBA would be a plus.
• Experience in project management and management of collaborations.
• Experience in tech/science evaluation (e.g., at Venture Capital, Tech Transfer Office).
• Ability to summarize experimental data, in an independent, efficient and organized manner.
• Experience in writing technical/scientific & BD documents: papers, public grants and BD.
• Presentations.
• Leadership capabilities, exceptional teamwork, interpersonal and communication skills.
• Independent, motivated, and collaborative person.
• Entrepreneurial: proactive, flexible, resourceful and have problem-solving attitude.
• Fluency in English.

We offer:

• Join a company with a groundbreaking technology.
• Work with top scientists and investors.
• Learn from inside how to lead a startup company.
• High visibility.

Our client's platform technology enables the efficient delivery of large genes using adenoassociated
vectors (AAV). The company overcomes one of the main limitations of AAV, which is their small packaging capacity, allowing the development of treatments for several diseases for which there are currently no treatments. The company has completed the largest Series A financing ever in the Spanish biotech sector.

Our client is looking for a Bioanalytical Science Manager to provide strategic leadership and oversee the development, optimization and execution of bioanalytical assays in support of AAV gene therapy programs. This position is located in Barcelona.

Main Responsibilities:

• Provide strategic and technical leadership and direction to the bioanalytical team to ensure the successful development, optimization and validation of bioanalytical methods.
• Experience with ligand binding techniques (immunoassays) such as ELISA, qPCR or electrochemiluminescence (MSD).
• Experience with biodistribution is a must.
• Previous experience with cell-based assays or LC-MS/MS applied to large molecules or gene therapy is a plus.
• Troubleshoot and resolve technical issues related to assay performance, providing guidance and expertise to the bioanalytical team and external partners.
• Lead analytical development efforts for non-clinical and clinical development. CMC experience is a plus.
• Oversee sample analysis and data interpretation for preclinical and clinical studies, ensuring accuracy, precision, and compliance with GLP regulations.
• Collaborate with cross-functional teams, including internal and external third parties, to ensure seamless integration of bioanalytical data into product development.
• Provide regulatory support as required.

Required Qualifications & Experience:

• Minimum of a Bachelor's degree in Biology, Biochemistry, Molecular Biology or related field; advanced degree preferred.
• A minimum of 7-10 years of relevant experience in the CRO, biotech or pharmaceutical industry.
• Solid experience in large molecule bioanalysis - immunoassays, biodistribution, and nonclinical and clinical analytical development - is a must.
• Gene therapy experience is a nice-to-have.
• Demonstrated expertise in managing relationships with external partners, including CROs, and overseeing outsourced activities.
• Hands-on experience working in a GLP regulated environment with a thorough understanding of GLP principles, regulatory requirements, and industry best practices.
• Strong analytical and problem-solving skills, with the ability to troubleshoot complex technical issues and develop innovative solutions.
• Excellent communication and interpersonal skills with the ability to work effectively in a team-oriented, fast-paced environment.
• Proficiency in data analysis, interpretation and reporting using relevant software tools.
• Fluency in English is a must and Spanish is preferred.

Our client's platform technology enables the efficient delivery of large genes using adeno-associated vectors (AAV). The company overcomes one of the main limitations of AAV, which is their small packaging capacity, allowing the development of treatments for several diseases for which there are currently no treatments. The company has completed the largest Series A financing ever in the Spanish biotech sector.

Our client is looking for a Director of Quality, responsible for establishing and developing quality systems and shaping the quality culture of the organization.

Main Responsibilities:

• Establish a culture of compliance and collaboration through the implementation and improvement of quality processes.
• Oversee and manage all GxP quality functions.
• Lead the development of pharmaceutical quality systems - aligning policies, processes and procedures for internal and outsourced activities.
• Ensure that all outsourced manufacturing activities and product testing are appropriate and conducted in accordance with company policies and GxP standards.
• Ensure quality agreements with key suppliers and partners are complete, approved and updated at appropriate intervals.
• Oversee risk assessments to determine the level of compliance risk. Lead the implementation of appropriate risk mitigation strategies.
• Provide guidance on investigations and corrective and preventive action (CAPA) plans for compliance issues and/or observations.
• Prepare and manage departmental operating plans and budgets.
• Oversee the hiring of staff and external consultants, as well as the training and mentoring of staff.

Required Qualifications & Experience:

• Ph.D. or Master's degree in Biopharmaceutical or related field.
• Minimum of 15 years of progressively responsible experience in the pharmaceutical/biotech industry, including 5+ years leading a quality function in development activities.
• Experience in establishing and/or enhancing the development of GxP quality infrastructure and systems in compliance with EU and US regulations.
• Experience in overseeing GLP and early phase GCP quality programs.
• Experience in overseeing GMP manufacturing of biologics (and preferablyATMPs) in CDMOs.
• Successful track record in managing GCP and GMP inspections.
• Knowledge and experience in negotiating quality agreements and managing supplier relationships and performance.
• Expert knowledge of quality risk assessment and management methodologies, including successful application and risk remediation.
• Strong leadership and interpersonal/communication skills. Demonstrated success in working effectively with senior scientific, medical and operational staff.
• Fluency in English is a must and Spanish is preferred.
• Eligibility (and experience) as an EU Qualified Person is also preferred.
• Relocation to Barcelona is preferred, but a hybrid position is an option.

The CaixaResearch Institute is a new leading international research center promoted by “la Caixa” Foundation. Our purpose is to boost the translational study of Immunology & Diseases and the development of ground-breaking Life Science Technologies, in line with global scientific and societal challenges, including an approach to Exposomic Sciences.

The CaixaResearch Institute vision is to support the best researchers in the field of Immunology by creating a dynamic and engaging environment, with a modern and flexible structure based on transversal research programs carried out through dedicated task forces, with the aim of

Enable an interdisciplinary understanding of immunology.
Meet the evolving needs of the health science community.

Boost translational research.

Main Responsibilities:

• Developing and implementing the CaixaResearch Institute’s knowledge and technology transfer processes, protocols and policies (IP policy, spin-off creation, VC funding, etc.)
• Fostering a culture of innovation within the organization and coordinating the Innovation Hub initiative (in early stages) to impulse innovation in research centers.
• Staying up to date with industry trends, technologies, and best practices related to innovation management.
• Identifying new business opportunities and potential areas for growth and development.
• Developing and maintaining international alliances and partnerships.
• Reporting about the progress and outcomes of the implemented innovation processes.
• Acting as interim research support office for guiding researchers with fundraising.
• Acting as interim project management office (PMO) of the center, facilitating the coordination of the different activities and communication with the different stakeholders.

Required Qualifications & Experience:

• Advanced degree in life sciences or engineering (Master or PhD), ideally combined with MBA or similar.
• 5 years of experience in a similar position.
• Deep knowledge of public and private research and innovation funding schemes (national and international).
• Deep knowledge of IP, tech transfer, spin-out process and policies.
• Solid understanding of project management methodologies.
• Business strategy, market research and analysis.
• Work collaboratively with others to drive innovation.
• Think creatively, communicate effectively.
• Versatile/flexible/resourceful.

We offer:

• Be involved in the creation of a new leading research organization from scratch.
• Impulse the creation of an innovation-based institution.
• Work with top-notch scientists.
• High visibility.

The CaixaResearch Institute is a new leading international research center promoted by “la Caixa” Foundation. Our purpose is to boost the translational study of Immunology & Diseases and the development of ground-breaking Life Science Technologies, in alignment with global scientific and societal challenges, including an approach to Exposomic Sciences.

The CaixaResearch Institute vision is to support the best researchers in the field of Immunology through the creation of a dynamic and engaging environment, with a modern and flexible structure based on transversal research programs operated through dedicated task forces, with the objective to:

• Enable an interdisciplinary understanding of immunology.
• Meet the evolving needs of the health scientific community.
• Boost translational research.

Main Responsibilities:

• Developing and overseeing the technical direction of the CaixaResearch Institute.
• Assessing the center’s current and future technological needs.
• Ensuring the correct definition, implementation, and future management of the center’s scientific-technical infrastructure.
• Recommending and managing the acquisition of any relevant new technology or equipment.
• Managing and coordinating the center’s technical personnel.
• Managing the budget for the purchase, functioning, and maintenance of the center’s scientific-technical infrastructure.
• Establishing and maintaining partnerships with external relevant stakeholders (i. e. other research centers, companies).
• Assisting researchers in correctly assessing their technical needs to facilitate both the planning and implementation of their research projects.
• Supporting and facilitating the proper execution of high-quality, innovative research projects, in compliance with any relevant regulations and standards.
• Ensuring the correct maintenance and upgrading of the center's scientific-technical infrastructure.
• Collaborating with other departments to ensure the smooth functioning of the research center.
• Coordinating the Biomedical Data Hub initiative for the CaixaResearch Institute, currently in early stages, with the objective to improve the management of biomedical data (FAIRification).

Required Qualifications & Experience:

• Advanced degree in life sciences (PhD) or engineering.
• Minimum of 5 years of experience in the management of scientific-technical research infrastructure, preferably in a life science research area.
• Ability to balance the technical demands of specific research projects with the needs of the research center as a whole.
• Familiarity with budget management and resource allocation.
• Ideally, knowledge of life science regulations and standards, including data management protocols.
• Strong leadership and project management skills.
• Ability to work collaboratively with other team leaders and stakeholders.
• Excellent communication and interpersonal skills.
• Strong problem-solving and analytical skills.

We offer:

• Be involved in the creation of a new leading research organization from scratch.
• Impulse the creation of an innovation-based institution.
• Work with top-notch scientists.
• High visibility.

Main responsibilities & purpose:

• Managing and executing clinical and safety pharmacology in the clinical trials including but not to limited to drug-drug interaction, DMPK, PK/PD and non-clinical ADME studies.
• Prepare and edit non-clinical documents for regulatory submission (e.g., IBs, INDs and regulatory briefing documents)
• Support product development with extensive knowledge and understanding of pharmacology pathways and mode of action.

Requirements and skills:

• PhD. in Biological Sciences, Toxicology, Pharmacology
• 6-8 years drug development experience, with minimum 3 years working in industrial pharmaceutical pharmacology/ADME/toxicology/safety/regulatory assessment drug development.
• Proven experience in design, coordination, analysis, and documentation of preclinical studies and in writing position papers on safety, toxicology, and pharmacology.
• Several years of professional experience in medical or scientific writing as well as written and oral communication skills
• Ability to work independently without much supervision.
• Successful experience working in a multicultural environment.
• Flexible, organized, team player, resilient.
• Proactive, independent problem solver, capable to excel in a fast-moving environment.
• Travel on an as-needed basis to investigational sites, conferences, and regulator meetings.
• Creative thinker with excellent communication & problem-solving skills,
• Fluency in English (written and spoken).