AddressDescription
Scientific Director, Large Molecules Drug Substance, Manufacturing Sciences and Technologies
J&J Innovative Medicine develops treatments that improve the health and lifestyle of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders and reproductive medicine.
The Large Molecules Drug Substance, Manufacturing Sciences and Technologies organization is seeking a Scientific Director to provide scientific and technical leadership to ensure compliance, resilience & competitiveness of J&J commercialized Value Optimization and Late Lifecycle portfolio.
The individual is expected to have a strong understanding of the Drug Substance development process from early through late development and a very good understanding of the impact of the process parameters on the product quality attributes.
The candidate is expected to leverage strong networking and influencing skills to ensure good collaboration with R&D, VCM, PES, Operations, Quality, Planning, Regulatory and various JSC and R&D functions.
The Scientific Director will drive technical and scientific leadership across programs/projects by developing breakthrough ideas and new approaches, acting as a technical mentor for project teams and individuals, being accountable for post approval submissions and authority interactions.
Responsibilities
- Acts as an internal expert with a direct impact on scientific and/or business objectives
- Contributes to defining scientific strategy for a program/project/technology with a focus on incorporating innovative and technically sound approaches into business application
- Creates and manages multiple complex programs and projects that deliver high quality results resulting in the accomplishment of multiple business objectives
- Has indirect and direct people management responsibility internally and externally (e.g. outsourced, working with external partners, etc.) with a significant impact on the business
- Leads the analysis of highly complex issues in a technical area and establishes resolutions/ decision points in a given program/project
- Identifies and analyses high-impact, complex and cross- departmental scientific/technical issues and gaps, and nascent scientific/technical opportunities in a specific technical area
- Seeks to contribute to improving business processes
- Stays ahead of the scientific/technical area by exploring new concepts and opportunities and remains knowledgeable with state of the art technology in pharmaceutical biologics manufacturing processes and product quality
- Owns and proactively shapes the control strategy of Drug Substance biologics processes in a commercial state
- Drives development of intellectual capital and continuous education and capability building
- Leads the proper documentation for filing submissions and acts as a senior author in the preparation of presentations, documents for regulatory filing, patents, scientific publications
- Review and monitor data management process to ensure that records are properly documented and shared internally
- Actively partners with R&D functions to translate process development knowledge into Manufacturing Science and Technologies processes
- Is knowledgeable of health authorities latest guidelines and policies regarding Drug Substance biologics
Nature of Communication
- Communicates overall strategy of the projects to others
- Serves as the liaison between team members and senior leadership
- Influences across disciplines with senior leaders and external partners to drive and align strategic and operational scientific activities between business functions
- Negotiates and solicits acceptance of new ideas, approaches, concepts through scientific leadership
Program/Project Management
- Contributes to budget and resource allocation on a project
- Sets and monitors priorities, budget, timeline and resources for team/ project
- Influences the initiation, development and termination of projects in a timely manner
- Directs the proper use and implementation for new technology to remain competitive
- Advises on current procedures and assesses potential improvements across products and processes
Qualifications
- The candidate has preferably a Ph.D. degree in Chemistry, Biochemistry Pharmaceuticals, Engineering, or the equivalent training/ experience.
- A Minimum of 10 years of experience in Drug Substance pharmaceutical development or pharmaceutical manufacturing or related post graduate academic experience/education is required and people leadership experience.
- Proven track record in leading technical/scientific team(s) and direct and/or indirect people management experience.
- Excellent written and oral communication skills and ability to influence peers, superiors, and partners is required.
- Primary in-depth experience in protein pharmaceutical development is needed including large molecule process development and analytics and proven experience in CTA and BLA authoring.
- Excellent interpersonal skills with the ability to adapt effectively to manage a growing portfolio.
- Motivated, self-starter able to work independently with demonstrated problem solving skills is required.
We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms and an excellent infrastructure.
If you feel attracted by this challenge and want to be part of a successful and growing organization, then please send us your online application (CV).
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/.
