Scientific Contractor - Final Fill

Johnson & Johnson; Sassenheim; Hybrid; EUR 55,000 - 96,000; Full time

Job summary

Johnson & Johnson in Sassenheim is seeking a Scientific Contractor, MSAT Advanced Therapies, to lead and support life cycle management, technology transfer and implementation projects. The SME will focus on fill and finish and sterile manufacturing for commercial lentiviral vectors.

You will collaborate with Operations, Quality and global MSAT, define validation strategies, write protocols, and drive process improvements.

Qualifications

• 5+ years of relevant experience and BS degree or equivalent, or 2+ years with MS/MBA/PhD.
• Extensive knowledge in a scientific/technical core area and cross-disciplinary expertise.
• Strong affinity with process technology and digitalization of manufacturing.
• Delivers local small projects or regional work streams under supervision.
• Defines objectives and tactics to achieve targets in teams or individually.
• Fluent English, strong communication, planning, and risk management skills.

Responsibilities

• Contribute to LCM for the Site.
• Act as Subject Matter Expert in USP, and fill and finish for commercial manufacturing of lentiviral vectors.
• Capable of leading and supporting investigations, facilitating risk assessments, and defining CAPAs.
• Lead and/or support Life Cycle Management projects.
• Define process validation strategies.
• Write and review validation protocols and reports.
• Ensure validation studies meet site standards and J&J guidelines.
• Integrate global standards into local production processes.
• Interface between Sassenheim Operations, Quality, global R&D, and MSAT.

Skills

Communication

Planning

Documentation practices

Risk management

Root cause analysis

Knowledge management

Independent worker

Education

BSc in Biochemistry/Biotechnology/Chemical Engineering

MSc/PhD considered a plus

Job description

Scientific Contractor, MSAT Advanced Therapies Contractor Final Fill

Location: Sassenheim, hybrid

Duration: 12 month contract

Hours: 40 hours per week

Imagine your next project leading and supporting Life cycle management, technology transfer, and technology implementation projects while serving as a Subject Matter Expert in fill and finish and sterile manufacturing for commercial manufacturing of lentiviral vectors.

Company: Johnson & Johnson Role: Scientific contractor DIVISION: Innovative Medicine Supply Chain (IMSC) DEPT NAME: Manufacturing Science and Technology (MSAT)

POSITION SUMMARY: The scientific contractor MSAT Advanced Therapies is responsible for leading and/or supporting Life cycle management, technology transfer and technology implementation projects. The scientific contractor MSAT Advanced Therapies acts as Subject Matter Expert in USP, DSP and/or final filling for commercial manufacturing of lentiviral vectors and communicates with different stakeholder departments. For this specific position, we are looking specifically for an SME in fill and finish and sterile manufacturing.

roles and responsibilities.

• Contribute to LCM for the Site
• Act as Subject Matter Expert in USP, and fill and finish for commercial manufacturing of lentiviral vectors
• Capable of leading and supporting (complex) investigations, facilitation of risk assessments and defining appropriate corrective and preventive actions
• Lead and/or support Life Cycle Management projects
• 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 Sassenheim site Operations, Quality, global R&D departments and the (global) MSAT organization
• Defining and implementing process improvements

how to succeed.

• 5+ years of relevant experience and BS degree or equivalent OR 2+ years with advanced degree MS/MBA/Ph.D. or equivalent
• Extensive knowledge of and experience in a scientific or technical core area. Building knowledge and expertise in other technical and business disciplines
• Strong affinity with process 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
• DEGREE: BSc in Biochemistry, Biotechnology, Chemical Engineering, or a related field. An Advanced degree (MSc/PhD) is considered a plus
• LANGUAGES: Fluent in written and spoken English

This role offers a very competitive hourly rate. This contract will run for 12 month contract

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”.