Principal Scientist, External Manufacturing Site Lead

Johnson & Johnson is recruiting for a Principal Scientist, External site lead within the manufacturing Science and Technology (MSAT) team located in Leiden, the Netherlands.

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 athttps://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.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more athttps://www.jnj.com/innovative-medicine

Position summary

The External Site Lead (ESL) within the MSAT Large Molecule Drug Substance team is the J&J single point of contact and responsible person for manufacturing sciences and technology activities at the assigned External Site (or CMO). The ESL is main point of contact for manufacturing technical aspects for the External Site (CMO) and strongly collaborates with key MSAT functions such as Global Technical Owners (GTOs), Technical Launch integrators (TLIs), and Innovation & Technology Deployment (ITD), among others. The ESL is core team member of the Virtual Management Team (VMT) in conjunction with Partnership and External supply (PES), External Quality (EQ), Procurement and Global Planning. In this role, the incumbent partners with stakeholders within MSAT, VMT and others (R&D, VCM, Engineering, etc.) as per the requirements to meet technical needs of NPIs & commercial products Life Cycle Management of the products at the External Site while managing ad hoc requests. The ESL is a key function within the J&J External Site model to establish the connections and partnership between internal (J&J) manufacturing sciences functions and the External Site. The role may support several key activities such as: site selection and due diligence, localization projects, Health Authorities submissions, Technology Transfers, technical and scientific support on issues and quality deviations, technology deployment, changes in the manufacturing process, CPV and resin life time reporting, and other queries and activities required in the Life cycle Management of a multi product External Site. This role is permanently based at Leiden or Cork and will act as PIP by at least monthly presence at the External Site in Denmark.

• Primary J&J contact for manufacturing sciences and technical activities at the assigned External Site.
• Represents MSAT at the Virtual Management team as core team member
• Participates in regular External Site – J&J Business Review e.g. QBRs (Quarterly Business Reviews).
• Understands the technical and scientific aspects of the drug substance manufacturing science and technology of the products and its translation into the life cycle management and product strategy needs.
• Monitors technical process and product performance of the products manufactured at the external manufacturing sites
• Provides technical input into quality deviations related to the manufacturing process and supports product impact assessment, root cause investigations and potential corrective and preventive actions in close collaboration with TLIs/GTOs and the External Site.
• Leads site specific investigations and supports global (multi-site) investigations in close collaboration with TLIs/GTOs
• Leads the assessment and implementation of manufacturing process changes in close collaboration with TLIs/GTOs
• Leads Technology deployment at the assigned External site, including data collection & data science tools
• Supports Technology transfers activities led by TLI, from PF2P to PPQ execution, reporting and fling submission
• Leads Life Cycle Management site specific activities for commercial products at the site e.g. CPV reports, resin lifetime reports, Annual Product Reports, Health Authorities questions, audits, etc.
• Understand each product strategy and needs and works closely with TLIs/GTOs in updating product strategy and deployment changes at the external site
• Leads the regular External Site Fit for Purpose technical assessments from MSAT perspective
• Responsible technical lead for identifying new technology or areas of improvements on current and future processes, capital utilization, cost of goods optimization, and advanced expertise on feasibility and risks management at the assigned External Site.
• Participates in technical, quality and compliance risk assessment and development of mitigation strategies and possible BCP option
• Supports Best Process at Launch (BPAL) assessment by providing input from the External Site processes.
• Strongly partners with the External site and J&J functions

QUALIFICATIONS

Specific knowledge

• Proven track record in large molecules in at least three of these areas: process development, new product introduction, technology transfer, process validation and/or ongoing production support.
• Accountability and success as product or project lead in LCM and/or new product introduction. Well established industrial, academic and regulatory track record.
• Demonstrated competency and experience with introduction or changes of Drug Substance products to manufacturing sites and thorough technical knowledge of manufacturing site unit operations.
• Demonstrated experience in supporting Life Cycle Management projects, investigations and innovation/optimization opportunities
• Contribution of DS technical and regulatory documents, routine technical support during execution, integration of Janssen Supply Chain (JSC) technical expertise into project execution
• Technology transfer and/or manufacturing process changes, internal and external, to plants in the JSC network is preferred
• Identifying and implementing opportunities for active decrease in DS COGs
• Partnership experience with external companies and/or suppliers is preferred

Personal and interpersonal skills / Leadership skills

• Demonstrated leadership in providing integration of activities, information across multifunctional groups and sites.
• Planning and logistics skills capable of effective integration of DS deliverables at the manufacturing site level.
• Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams.
• Ability to influence and lead peers, superiors, and external partners, including interaction with senior management.
• Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly.
• Ability to manage complexity, uncertainty and change.
• Ability to manage conflicts and resolving them

Personal attitude and mindset

• Motivated, self-starter able to work independently with demonstrated problem solving skills.
• Drives for innovation and change to ensure competitiveness.
• Can-do mentality: takes initiative, creates a result-oriented working spirit in his/her team.
• Ability to work under pressure and resolve conflicts

Education:

• Engineer, MSc or equivalent in a technical field (Chemistry, Pharmaceutics, Biological Sciences, Chemical Engineering) with +4 years of experience in biopharmaceutical development or manufacturing arena.

Language:

• Fluent in written and spoken English

Working conditions:

• Works in an international environment across different time zones
• Travel: ~30-50% of time based on role and specific business goals
• Virtual Network interactions, utilizing available infrastructure to communicate with Key Partners and Stakeholders

#LI-MV2

#LI-Hybrid

Summary

• Job titlePrincipal Scientist, External Manufacturing Site Lead
• FunctionSupply Chain Engineering
• Sub functionProcess Engineering
• CategoryPrincipal Engineer, Process Engineering (ST7)
• LocationLeiden, South Holland, Netherlands
• Date postedDec 05 2024
• Requisition number2406224227W