Principal Scientist Biotherapeutics
5 dagen geleden
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.
The Leiden-based Analytical Development team, part of the Discovery, Product Development and Supply (DPDS) organization in Johnson & Johnson, is recruiting for a Principal Scientist, Large Molecule to take on the role of Analytical Scientific Integrator.
The Leiden analytical development team is responsible 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 collaboration 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 scientific integrator plays a critical role in our team and is responsible for all global analytical development activities needed to bring a protein product to our patients. That means you will lead local and global teams and participate in CMC and/or Value Stream teams to deliver the program’s analytical development needs. The role is highly dynamic with priorities changing frequently, and highly visible given both the criticality of the role and the wide range of partners and teams you will need to work with globally. The role therefore offers the opportunity to deploy and further develop your leadership, strategic, and scientific skills in biotherapeutic analytical development.
Core Responsibilities:
- Lead analytical efforts in life cycle management, including but not limited to, method replacements, comparability studies, shelf life extensions and specification management.
- Responsible for global filings, post approval submissions, health authority interactions and audits.
- Represent AD on the CMC and VS team and be accountable for all AD project deliverables.
- Provide strategic and technical leadership in analytical development and lead a cross-functional scientific team consisting of members from each of the AD sub-functions.
- Effectively communicate project status/overview, resources, budget, and issues to senior management.
- Accountable for project risk management including development of appropriate mitigation strategies and escalation to senior management.
- Interact with and influence various partners outside of DPDS including Manufacturing, Regulatory, Quality, Discovery, and external partners.
**Qualifications**:
- A minimum of a Master’s degree in Analytical Chemistry, Biochemistry, Biological Science, or a related scientific field with at least 8 years of experience in biopharmaceutical development is required. A Ph.D. in Analytical Chemistry, Biochemistry, Biological Science, or a related scientific field with at least 3 years of experience in biopharmaceutical development is preferred.
- Working knowledge of biotherapeutic development and analytical strategy including analytical protein characterization, separation techniques, and biological potency assays is required.
- Experience authoring and reviewing BLA/MAA sections and addressing health authority questions is preferred.
- Must have strong leadership, influencing, communication (English, oral and written), interpersonal, and negotiation skills and be able to collaborate across teams in a matrix environment.
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.
Hiring Managers: Maarten Groeneveld and Clara Esteve Gil
- 2 vacancies available
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