Principal Scientist MSAT Emerging Tech

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Biotherapeutics R&D

Job Category:

Scientific/Technology

All Job Posting Locations:

Schaffhausen, Switzerland

Job Description:

POSITION SUMMARY:

The Senior Scientist/Principal Engineer – Emerging Technologies, Innovation Technology and Deployment will lead cross functional teams to develop and deliver projects required to achieve goals related to MSAT strategic

pillars such as Process Intensification (PI), Integrated Quality/Real Time Release (IQRTR) and new pillars as

appropriate and specified in yearly cascades.

This individual will provide technical support and leadership to support advancement of technology innovations for NPIs, LCMs across all sectors (SM, LM, Adv Ther) to enhance yield, reliability, compliance & efficiency of product value chains end-to-end, i.e., support product life cycle management, and effectively collaborate across different functions (i.e., MTO, R&D, Regulatory, Quality).

PRINCIPAL RESPONSIBILITIES:

Technology Development - The Senior Scientist/Principal Engineer will partner with R&D, MSAT platforms,

Quality, Regulatory and MTO resources to lead and/or coordinate PoP and PoC technology studies in laboratory, pilot, or commercial scale environments and drive overall technology innovation.

Technical and Scientific Leadership – this individual will provide technical and scientific leadership in support of PAT and process technology as it relates to PI or IQRTR with the final aim of enabling process control, process

understanding, real-time release, and manufacturing process improvements.

Strategic Leadership – This individual will support the creation, maintenance, and advancement of an overall

strategy for projects within PI, IQRTR, or lead key elements of the strategic roadmap. Identify areas of highest

impact for implementation of new technologies, focusing on broad applicability and ease of introduction.

Knowledge Management – This individual will develop, manage, troubleshoot, and transfer advanced knowledge on new process technology and/or PAT in support of emerging technology development and deployment.

Investigations - This individual will lead complex technical investigations as they relate to PI or IQRTR to

resolve issues related to PAT, and/or new process technologies.

People Leadership - This individual may hire, onboard, and lead a team of (associate) scientists, post-docs and/or students to advance PoP & PoC execution.

KNOWLEDGE SKILL AND ABILITY REQUIREMENTS:

Required:

• Preferred candidate will have at least 3 years of (industrial) experience in their field of expertise (Process Engineering, PAT, etc.) with past proven field experience.

• Strong scientific background in leading technical teams and writing technical reports.

• Excellent communication, verbal, written, and presentation skills.

Preferred:

• Expertise in process manufacturing technology (small or large API, vaccines, cell and gene therapy, etc.) • Experience with executing the operational responsibilities of a laboratory and practical operation of reduced scale manufacturing equipment.

• Project management qualification and experience.

• Familiarity with manufacturing cGMPs, Systems Qualification, Process Validations, Process Sciences, Tech Transfers, QbD, advanced analytical technology, PAT, Continuous Manufacturing, Modular Manufacturing.

• Exposure to Quality Assurance and Regulatory Compliance cGMP and EH&S

• Operational Excellence experience in Lean, Process Excellence, and/or Design Excellence

• The ability to develop and/or assess Business Cases, perform feasibility studies, and develop action plans related to Processes Improvements, Costs and/or Quality improvements.

• The ability to operate in a complex global matrix organization, i.e., multiple stakeholders, with limited guidance and supervision

COMPETENCY (knowledge, skills, abilities, and experience required):

DEGREE:

Minimum requirements: BS or MS with 6-8 years experience or Ph.D. with 3 years experience

B.S. or M.S. in Science or Engineering ((Biomedical, Biochemical, Analytical Chemistry, Physical Chemistry,

Biotechnology, Pharmacy, Life Science Technology, Bioinformatics, Computational Biology) or equivalent.

Advanced degree PhD, Engineering Doctorate or equivalent preferred.

LANGUAGES:

Fluent in written and spoken English

SPECIFIC SYSTEMS:

Document control systems, such as TruVault, Financial Systems such as Planisware and gCRAFT, Contract

Management tools for Confidential Disclosure Agreements, QMS, such as Trackwise

PHYSICAL REQUIREMENTS/WORKING CONDITIONS:

Works in an international environment across different time zones

Frequent travel required

Travel: Min 20% - project dependent

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Biochemistry, Biotechnology, Clinical Research and Regulations, Clinical Trial Designs, Coaching, Critical Thinking, Drug Discovery Development, Emerging Technologies, Chemistry, Manufacturing, and Control (CMC), Molecular Diagnostics, Organizing, Pharmacovigilance, Presentation Design, Process Improvements, Productivity Planning, Scientific Research