Scientific manager

Johnson & Johnson; Leiden; On-site; EUR 69,000 - 120,000; Full time

Benefits offered by this job

Flexible hours

Home office possibilities

Job summary

Johnson & Johnson Innovative Medicine Leiden is seeking a Scientific Manager to lead the CGTA analytics group. The role focuses on biophysical/separation tech methods for viral/vector products, with leadership of a 22-person team and collaboration across process development, quality, and regulatory authorities.

The candidate will guide method development, validation, and lifecycle management using AQbD, driving regulatory filings and patents.

Qualifications

• At least 4 years post-PhD or 8 years post-Master in analytical chemistry or life sciences.
• Experience with biophysical and separation-based technologies and method development principles for (viral) vector product development.
• Proven people leader experience.
• Preferably direct experience with clinical cell and gene therapy product development and/or method development (ICH Q2) and GMP.

Responsibilities

• Leads a complementary team developing biophysical and separation technology-based methods providing scientific mentor and has a talent for spotting people development opportunities.
• Acts as a technical analytical lead to strengthen our product development strategy, specifically lipid nanoparticle (LNP)-based products.
• Actively shares technical expertise in biophysical and separation-based technologies, such as liquid chromatography (LC), light scattering and capillary electrophoresis (CE) and drives selection and implementation of the most suitable technology.
• Strives to build the life cycle management from development using AQbD principles up to and including validation of methods for release and characterization of our products demonstrating a lean mentality for optimization.
• Enjoys working in a multidisciplinary team and has strong capabilities to collaborate with scientists across multiple teams.
• Takes ownership as author or reviewer in the preparation of presentations, reports and documents for regulatory filing and patents.

Skills

Biophysical technologies

Separation-based technologies

Liquid chromatography (LC)

Capillary electrophoresis (CE)

Light scattering

People leadership

GMP

Education

PhD degree

Master degree

Job description

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Biotherapeutics R&D

Job Category:

People Leader

All Job Posting Locations:

Leiden, South Holland, Netherlands

Job Description:

For our department in Leiden, we need an ambitious

Scientific Manager Cell and Gene Therapy Analytics

Location: Leiden

Hours: 32-40

Introduction of company and team:

At Johnson & Johnson Innovative Medicine, we are working to build a world without disease. Redefining lives by finding new and better ways to prevent, intercept, treat and cure disease encourages us. We bring together the best minds and pursue the most promising science. We are Johnson & Johnson Innovative Medicine. We collaborate with the world for the health of everyone in it.

Our department

The Cell and Gene Therapy Analytics (CGTA) team is an energetic and dynamic group (22 team members), which is part of Cell and Gene Therapies Analytical Development (CGT AD) Leiden, responsible for developing methods to characterize our (viral) vector products (e.g. based on Adenovirus, AAV, lentivirus and RNA). Together, we use molecular, biological, biophysical and separation-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:

• Leads a complementary team developing biophysical and separation technology-based methods providing scientific mentor and has a talent for spotting people development opportunities.
• Acts as a technical analytical lead to strengthen our product development strategy, specifically lipid nanoparticle (LNP)-based products.

• Actively shares technical expertise in biophysical and separation-based technologies, such as liquid chromatography (LC), light scattering and capillary electrophoresis (CE) and drives selection and implementation of the most suitable technology.
• Strives to build the life cycle management from development using AQbD principles up to and including validation of methods for release and characterization of our products demonstrating a lean mentality for optimization.
• Enjoys working in a multidisciplinary team and has strong capabilities to collaborate with scientists across multiple teams.
• Takes ownership as author or reviewer in the preparation of presentations, reports and documents for regulatory filing and patents.

Requirements:

The perfect candidate will have at least 4 years of experience after a PhD degree (or at least 8 years of experience after Master degree) in analytical chemistry or life sciences. In general, experience in biophysical and separation-based technologies and a broad comprehension of method development principles for (viral) vector product development is required. In particular, the following is required:

• In-depth knowledge with biophysical and separation-based technologies, such as liquid chromatography (LC), light scattering and capillary electrophoresis (CE)
• Deep scientific insights into (viral) vectors and specifically LNP-based product development in pharmaceutical industry
• Confirmed people leader experience
• Preferably also, direct experience with clinical cell and gene therapy product development and/ or method development (according ICH Q2) and quality systems such as GMP

The candidate should have the following skills:

Proven practical lab skills for biophysical and separation-based technologies

Pragmatic and passionate in the lab

Phenomenal teammate

Outspoken with a can do mentality

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

We value an ethical working environment, as described in our Credo, where trust, diversity, equity and inclusion is the fundament for success.

Our company offers a broad range of benefits and a competitive salary, as well as flexible hours and home office possibilities. Are you our perfect candidate and ready to take this step in your career? Help us to get our Cell and Gene Therapy products on the market and secure your place in this outstanding opportunity!
Contract is for one year with possibility to extend
#DPDS

Required Skills:

Preferred Skills:

Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Clinical Data Management, Clinical Research and Regulations, Clinical Trial Designs, Developing Others, Drug Discovery Development, Inclusive Leadership, Leadership, Molecular Diagnostics, Pharmacovigilance, Process Improvements, Productivity Planning, Quality Assurance (QA), Scientific Research, Team Management, Technical Credibility

The anticipated base pay range for this position is:

€68,600.00 - €119,600.00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.