SR SCIENTIST - UPSTREAM DS GLOBAL TECHNICAL OWNER

Johnson & Johnson is currently seeking a Sr Scientist - Upstream DS Global Technical Owner to join our team located in Leiden (Netherlands) or Cork (Ireland).
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.
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The Upstream Drug Substance Global Technical Owner (DS GTO) is responsible for the holistic manufacturing sciences and technology Lifecycle Management within Large Molecule Drug Substance for the upstream processes of the assigned product.
In this role the incumbent is a member of the MSAT LM DS VO team and is charged with leading Life Cycle Management activities and related initiatives or projects across sites for the upstream processes of given commercial Large Molecule Drug Substance product to drive standardization, robustness, and optimization.
The Upstream DS GTO works closely with the product DS Global Technical Owner, who acts as overall Ds product lead and is accountable for all DS process steps.
Within the manufacturing sciences and technology context, this person will provide the upstream product management and coordination, technical and scientific deep insight to effectively deliver LCM needs and projects aligned with the John & Johnson Biologics Drug Substance Supply Chain network strategy and supply chain needs, for both internal and external manufacturing facilities.
This role will partner with site MSAT, R&D, Quality, Operations, Value Chain Management, and Regulatory (among others) to ensure the upstream product Life Cycle Management short term and strategic needs are met.
The incumbent must be able to work independently to drive and execute projects of a complex nature where analysis of situations or data requires an in depth evaluation of various identifiable factors in multifunctional areas, and must have strong communication skills to influence other functions/levels outside of own group and effectively leads cross functional and cross organizational teams to generally attain expected results for all parties.
Strong knowledge in biologics upstream drug substance manufacturing processes is a must.
Experience in other areas such as Drug Substance Downstream processes, Quality, R&D and Manufacturing Operation is highly desirable.
Reporting Lines Supervisor.
Director MSAT LM DS VO Direct reports.
NA Tasks and Responsibilities Lead Upstream Life Cycle Management short term and strategic needs, including when applicable leading investigations, projects and initiatives.
Member of the DS multidisciplinary technical team as Upstream lead Masters the technical and scientific aspects of the manufacturing science and technology of upstream processes the assigned product and its translation into the life cycle management and product strategy needs Monitors technical process and product performance across internal and external manufacturing sites Responsible to assure manufacturing robustness, standardization and optimization for the upstream processes of the assigned product Leads upstream complex and global investigations in close partnership with site.
Leads complex and global initiatives / projects in close partnership with sites.
Supports site MSAT in coordination and scientific input when applicable as a second layer of support to manufacturing operations.
Represent MSAT and partner with manufacturing operations, R&D, regulatory, VCM, PES and quality to support developing and implementing product strategy technical road map.
Accountable technical lead for identifying new upstream technology or areas of improvements on current and future processes, capital utilization, cost of goods optimization, and advanced expertise on feasibility and risks management.
Supports Process Validation and regulatory filing activities for Upstream processes for the assigned product.
Works closely with the DS Global technical Owner, who is end to end accountable of the Ds processes across sites, and also with the Downstream DS Technical Owner for the assigned product.
Job interaction areas Internal.
functional departments within MSAT, CMC teams, Value Change Teams, VCM, regulatory affairs, TDS, PQM, PES, manufacturing operations, among others.
External.
CMOs Qualifications COMPETENCY (knowledge, skills, abilities and experience required).
1.
Specific knowledge Proven track record in large molecule 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 managing Life Cycle Management projects, investigations and innovation/optimization opportunities Integration of new and optimized/intensified DS manufacturing processes from R&D into the supply chain or within the life cycle management in supply chain.
Contribution, review and approval 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 - preferred Identifying and implementing opportunities for active decrease in DS COGs.
Taking part in GP assessments led by the VCL - preferred 2.
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 and change.
3.
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 DEGREE.
Engineer, MSc or equivalent in a technical field (Chemistry, Pharmaceutics, Biological Sciences, Chemical Engineering) with +4 years of experience in the DS biopharmaceutical development or manufacturing arena.
LANGUAGES.
Fluent in written and spoken English SPECIFIC SYSTEMS.
Document management systems such as ERIS, Truvault, SAP, MS Office applications TrackWise Planisware Minitab or similar statistical software PHYSICAL REQUIREMENTS/WORKING CONDITIONS.
Works in an international environment across different time zones Travel.
~10% of time based on role and specific business goals Virtual Network interactions, utilizing available infrastructure to communicate with Key Partners and Stakeholders 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.
At Johnson & Johnson, we all belong.