Sr Scientist Biotherapeutics RD

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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Job Description:

For our department in Leiden, we need an ambitious Senior Scientist Cell and Gene Therapy Analytics.

Location: Leiden

Hours: 32-40

Introduction of team:

Our department

The Cell and Gene Therapy Analytics (CGTA) team is an energetic and dynamic group (23 team members), which is part of Advanced Therapies Analytical Development Leiden (AT AD-L), responsible for developing methods to characterize our (viral) vector products (e.g. based on Adenovirus, AAV, lentivirus and RNA). Together, we use molecular, biochemical and cell-based technologies to assess quantity, potency, purity, and identity characteristics of our products. We have a pivotal role between the process development, quality unit and regulatory authorities.

Responsibilities and Duties:

We are looking for a senior scientist with focus on potency method development for our product platforms, such as AAV and lentivirus, who:

• Actively shares technical expertise in molecular technologies, such as quantitative/ digital (q/d)PCR, biochemical technologies, such as ELISA, Flow cytometry, and MSD, and cell-based potency assays in order to drive selection and implementation of the most suitable technology.
• Enjoys working in a multidisciplinary team and driving process analytical support and method development up to and including validation activities of the team as a whole.
• Strives to craft the life cycle management from development up to and including validation of methods for release and characterization of our products with hands-on involvement.
• Acts as a technical lead to strengthen our product development strategy.
• Has strong capabilities to collaborate with scientists across multiple subject areas.
• Takes ownership as author in the preparation of presentations, reports and documents for regulatory filing and patents.
• Supports the continuous improvement of an efficient and safe lab organization and contributing to data digitalization.

Requirements:

The perfect candidate will have a PhD degree (or equivalent) in life sciences with extensive use of molecular and biochemical technologies. A broad understanding of relevant technologies and method development principles for viral vector product development/commercialization process and GMP is required. In particular, the following:

• In-depth knowledge on molecular and biochemical technologies, such as quantitative/ digital (q/d)PCR, ELISA, Flow cytometry, MSD, and cell-based assays
• Broad interest and scientific understanding of viral vectors
• Proven practical lab skills
• Preferably also, pharmaceutical experience in development of cell and gene therapy and/or vaccine products or method development (according ICH Q2) and quality systems such as GMP

The candidate should have the following skills:

• Assertive with a can do mentality
• Great teammate
• Organizational sensitivity and conflict resolution skills
• Critical thinker valuing accuracy in the execution of your work and that of others
• Excellent written and verbal communication skills in English

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.