Scientific Manager

Scientific Manager Wanted! Join the dynamic Cell and Gene Therapy Analytics team, where they are at the forefront of developing cutting-edge analytical methods for viral vector products. We seek a passionate and pragmatic lab professional with proven practical skills in biophysical and separation-based technologies. As a phenomenal teammate with a can-do attitude, you'll thrive in a collaborative environment, contributing to the characterization of novel therapies. Your organizational and conflict resolution skills will be invaluable as they bridge process development, quality, and regulatory affairs. Come be a pivotal part of pioneering the future of cell and gene therapy!

Embark on a transformative journey with our client, a powerhouse dedicated to forging a world unburdened by disease. Driven by the pursuit of novel and superior strategies for disease prevention, interception, treatment, and cure, this visionary organization unites exceptional intellects and groundbreaking scientific endeavors. The organisation stands as a testament to collaborative innovation, working hand-in-hand with global partners to safeguard the health of all. Within this dynamic environment, the Cell and Gene Therapy Analytics (CGTA) team, a vibrant collective of 22 members, operates at the forefront of innovation within Cell and Gene Therapies Analytical Development (CGT AD) Leiden. Their critical mission is the development of sophisticated analytical methods designed to meticulously characterize the company's cutting-edge viral vector products, including those based on Adenovirus, AAV, lentivirus, and RNA. Leveraging a formidable arsenal of molecular, biological, biophysical, and separation-based technologies, the CGTA team diligently assesses the quantity, potency, purity, and identity of these vital products. They serve as a linchpin, bridging the crucial interfaces between process development, the quality unit, and regulatory authorities, ensuring the highest standards of scientific rigor and product integrity. A Unique Opportunity for a Scientific Manager to Lead and Innovate Our client seeks a visionary Scientific Manager to lead a complementary team focused on developing state-of-the-art biophysical and separation technology-based methods. This role demands a natural scientific mentor with an exceptional aptitude for identifying and nurturing talent within the team. The ideal candidate will act as a pivotal technical analytical lead, significantly bolstering the product development strategy, with a particular emphasis on lipid nanoparticle (LNP)-based products. This individual will be instrumental in actively disseminating deep technical expertise in biophysical and separation-based technologies, including advanced techniques such as liquid chromatography (LC), light scattering, and capillary electrophoresis (CE). A core responsibility will be to champion the selection and seamless implementation of the most effective technologies to meet evolving analytical challenges. Furthermore, this role calls for a proactive approach to managing the entire lifecycle of analytical methods, from early-stage development utilizing Quality by Design (QbD) principles, through to validation for product release and characterization. A commitment to a lean mentality, driving continuous optimization and efficiency, will be paramount. The successful candidate will thrive in a multidisciplinary setting, demonstrating strong collaborative capabilities to foster synergy with scientists across various teams. A key facet of this leadership position involves taking ownership as an author or reviewer in the meticulous preparation of presentations, reports, and essential documents required for regulatory filings and patent applications. Join our client and be a driving force in shaping the future of medicine.

This is an exceptional opportunity for a highly experienced candidate with a minimum of 4 years' post-PhD (or 8 years' post-Master's) in analytical chemistry or life sciences. We require a strong command of biophysical and separation-based technologies, alongside a comprehensive understanding of method development principles for (viral) vector product development. Key Requirements: Technical Mastery: In-depth knowledge of biophysical and separation technologies (LC, light scattering, CE). Pharmaceutical Expertise: Deep scientific understanding of (viral) vectors and LNP-based product development. Proven Leadership: Demonstrated experience leading people and teams. Preferred Qualifications: Clinical cell and gene therapy product development, ICH Q2 method development, and GMP quality systems experience. Essential Skills:

• Advanced practical laboratory skills in biophysical and separation technologies.
• A pragmatic and passionate approach to laboratory work.
• Exceptional teamwork and collaboration abilities.
• A confident, proactive attitude with a "can-do" mindset.
• Strong organizational awareness and conflict resolution skills.
• A critical and accurate approach to all aspects of your work.
• Excellent written and verbal English communication.

Salary is competitive, ranging from €68K to €119K. Furthermore, you'll enjoy outstanding secondary benefits, befitting a position at one of the world's foremost pharmaceutical companies.

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