Scientific Contractor - None Conformance

Johnson & Johnson; Sassenheim; On-site; EUR 76,000 - 124,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Leiden is seeking a Scientific Contractor to own quality records within the MSAT Advanced Therapies team, acting as a Subject Matter Expert in USP/DSP for commercial manufacturing of pharmaceutical proteins and vaccines.

You will contribute to life cycle management, technology transfer, and digitalization projects, while defining validation strategies and ensuring adherence to Johnson & Johnson guidelines and site standards.

Qualifications

• 2+ years of relevant experience and BS degree or equivalent OR advanced degree MS/MBA/Ph.D. or equivalent.
• Knowledge of quality management systems.
• Fluent in written and spoken English.

Responsibilities

• Contribute to LCM/New Technology Introduction for the Site.
• Capable of supporting complex investigations and risk assessments.
• Support introduction of new technologies and digitalization projects.
• Act as Subject Matter Expert in USP and/or DSP for commercial manufacturing of pharmaceutical proteins and vaccines.
• Define (process) validation strategies.
• Write and review (process) validation protocols and reports.
• Responsible that validation studies are executed conform site standards and Johnson & Johnson guidelines and meet the quality requirements.
• Ensure integration of the global standards into local production processes.
• Act as primary interface between the Leiden site Operations, Quality, BTDS departments and the MSAT organization.
• Defining and implementing process improvements.

Skills

Quality management

English fluency

Communication

Education

BS in Biochemistry/Biotechnology/Chemical Engineering or related

MS/MBA/PhD or equivalent (advantage)

Job description

Imagine your next project as a Scientific Contractor in MSAT Advanced Therapies, where you will act as a Subject Matter Expert and own quality records in the quality management system to support commercial manufacturing and groundbreaking healthcare projects.

Johnson & Johnson is seeking a Scientific Contractor for the Innovative Medicine Supply Chain (IMSC) division within the Manufacturing Science and Technology (MSAT) department. The scientific contractor MSAT Advanced Therapies is responsible for supporting Life cycle management, technology transfer and/or technology implementation projects. The scientific contractor MSAT Advanced Therapies acts as Subject Matter Expert in USP, DSP and or Fill and Finish for commercial manufacturing of lentiviral vectors and communicates with different stakeholder departments. For this specific position, we are looking for someone to own quality records in the quality management system.

roles and responsibilities.

• Contribute to LCM/New Technology Introduction for the Site
• Capable of supporting complex investigations and risk assessments
• Support introduction of new technologies and digitalization projects
• Act as Subject Matter Expert in USP and/or DSP for commercial manufacturing of pharmaceutical proteins and vaccines
• Define (process) validation strategies
• Write and review (process) validation protocols and reports
• Responsible that validation studies are executed conform site standards and Johnson & Johnson guidelines and meet the quality requirements
• Ensure integration of the global standards into local production processes
• Act as primary interface between the Leiden site Operations, Quality, BTDS departments and the MSAT organization
• Defining and implementing process improvements

how to succeed.

• 2+ years of relevant experience and BS degree or equivalent OR advanced degree MS/MBA/Ph.D. or equivalent
• Knowledge of quality management systems
• Knowledge of and experience in a scientific or technical core area. Building knowledge and expertise in other technical and business disciplines
• Affinity with process (analytical) technology and digitalization of manufacturing
• Delivers local small projects, regional project work streams or departmental programs successfully under supervision. Selects applicable engineering/scientific tactics
• Proposes project and/or program goals and tactics. Assists in defining objectives to achieve targets on a team and/or individual level
• Demonstrates the ability to communicate in business and technical terms with equal effectiveness
• Skills in communication, planning, documentation practices, risk management, root cause problem solving and knowledge management
• Works independently within scope, receiving general guidance
• BSc in Biochemistry, Biotechnology, Chemical Engineering, or a related field. An Advanced degree (MSc/PhD) is considered a plus
• Fluent in written and spoken English

This role offers a very competitive hourly rate. This contract will run for Not specified

you are welcome here.

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow. Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Diversity, Equity & Inclusion.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.