ABOUT US:
We are dedicated to the research, design, validation, manufacture and distribution of anti-allergic vaccines (immunotherapy sector).
We have a Technical, R&D and Clinical Trial headquarters in Zamudio, our only production centre for the moment. In this sense, we have a strong growth forecast.
Our value proposition for employees is as follows:
- PEOPLE-CENTRIC: We focus on people.
- SELF-DEMANDING PEOPLE: We promote individual self-demand in pursuit of common achievement.
- CURIOUS PEOPLE: We learn by innovating, valuing the experience that each person can bring to the organisation.
ABOUT THE JOB:
We are looking for a New Product Development Lead to join our R&D Department in Zamudio.
Reporting to the R&D Management Team, you will be responsible for leading the New Products Section, ensuring the successful execution of product development activities, coordinating multidisciplinary projects, and managing a highly qualified scientific team while maintaining the highest standards of quality, safety and regulatory compliance.
Mission: To lead the New Products Section in alignment with the company’s strategic objectives, driving innovation in allergen immunotherapy products, ensuring compliance with GLP/GMP requirements, and promoting scientific excellence, operational efficiency and team development.
Main tasks and Responsibilities:
- Project Leadership: Lead product development projects, including process improvements, lifecycle management and scale-up activities from R&D to pilot production, Coordinate internal and external collaborations related to new product development, Ensure projects are delivered according to timelines, quality standards and business objectives.
- Pre-Clinical and Regulatory Coordination: Coordinate pre-clinical studies in compliance with GLP requirements, Support Regulatory Affairs in the preparation of responses to health authorities and technical justifications, Coordinate the drafting, review and implementation of SOPs and manufacturing guidelines.
- Quality, Safety and Compliance: Act as Change Control Owner for relevant R&D and New Products activities, Serve as the designated safety representative within the R&D department, Oversee qualification, maintenance and service activities for R&D equipment and laboratory infrastructure, Promote compliance with GLP, GMP and internal quality management standards.
- Team Leadership: Plan, organize and supervise the activities of the New Products Section team, Lead and develop a multidisciplinary scientific team, providing technical guidance and fostering professional growth, Ensure efficient allocation of human and material resources, Promote a collaborative, innovative and results-oriented working environment.
Requirements:
- Education & Technical Background: PhD in Biochemistry, Microbiology, Biology, Immunology or a related Life Sciences discipline, Minimum 3 years of experience working in GMP and/or GLP environments, Proven experience operating within highly regulated quality management systems, Safety Management certification will be considered an asset.
- Leadership & Languages: Demonstrated experience leading scientific or technical teams (minimum 2–3 people), Native or fluent Spanish, Excellent English communication skills (minimum C1 level), German language skills (A1 or above) will be considered a plus.
Remuneration:
- Competitive compensation package based on experience and qualifications
- Opportunity to lead strategic R&D projects within an innovative immunotherapy company.
- Participation in international and multidisciplinary collaborations.
- Professional development within a growing and science-driven organisation.
- Collaborative working environment focused on innovation, quality and continuous improvement.
Observations: We are looking for a creative and achievement-oriented Team Lead, with a firm but empathetic leadership style, used to developing relationship models based on trust within his team and to work transversally with the rest of the areas.
