Principal Scientist Biologics AD

Job title:

Principal Scientist Biologics AD

Company:

Johnson & Johnson

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.The Leiden-based Analytical Development (AD) team, part of the Discovery, Product Development and Supply (DPDS) organization in Johnson & Johnson, is recruiting for a Principal Scientist, Biotherapeutics. The position is located in Leiden, The Netherlands (3-5 days in the office).The team has responsibility for a wide range of activities to help the development and commercial manufacturing of our protein products. Our focus ranges from method development, comparability studies, protein characterization, complex investigations, life cycle management to the activities needed to make those a reality, such as technical innovation, lab operations, regulatory filings, automation and advanced data analytics. Science and innovation are at the heart of what we do, realized by close teamwork based on mutual respect and passion for delivering for our patients! We are a highly diverse team, with over 10 nationalities from different backgrounds, operating in an international environment. Working in the Leiden AD team offers the opportunity to learn firsthand what it takes to bring our products to the patient across product development and commercialization.The candidate will be part of a multidisciplinary protein characterization team and will lead projects in areas such as technology transfers, method remediations, new characterization method evaluations and introductions, complex investigations and others.Core Responsibilities:

• Act as subject matter expert (SME) in both local and global teams.
• Develop protein characterization methods in support of product-related protein characterization studies.
• Lead analytical comparability studies to support technology transfers within the commercial portfolio.
• Lead and support Data Automation efforts in efficiency improvement projects, for example setting up automated data processing workflows in MS software.
• Responsible for readiness of part of the liquid-chromatography mass-spectrometry (LC-MS) infrastructure.
• Prepare documentation to support regulatory filings and prepare responses to regulatory inquiries from health authorities
• Communicate effectively around project status/overview and ensure timely escalation of any critical challenges to (senior) management.

• A minimum of a Master’s degree in Analytical Chemistry, Biochemistry, Biological Science, or a related scientific field with at least 4 years of experience in biopharmaceutical development is required. A Ph.D. in Analytical Chemistry, Biochemistry, Biological Science, or a related scientific field in biopharmaceutical development is preferred.
• Hands-on LC-MS, data processing, and interpretation experience is required.
• Ability to lead projects is required.
• Working knowledge and/or experience in using GenAI and other automation tools is highly preferred.
• Experience authoring and reviewing BLA/MAA sections and addressing health authority questions is highly preferred.
• Must have leadership, influencing, communication (English, oral and written), interpersonal, and negotiation skills and be able to collaborate across teams in a matrix environment.
• This position is to be based on-site for at least 3 days a week, and may require up to 10% travel.
• Solid understanding of biotherapeutic development and analytical strategy including analytical protein characterization, separation techniques, and biological potency assays is preferred.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Expected salary

Location

Leiden, Zuid-Holland

Job date

Sat, 14 Dec 2024 23:37:20 GMT

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