Scientist, Quality Engineering, Regulatory Compliance Specialist

Location: Sassenheim

Scientist MSAT Advanced Therapies

Location:

Sassenheim, Netherlands (Hybrid working - 3 days onsite, 2 remote)

Duration: 12 months Contract

Hours:

40

This role does not accept freelancers

Imagine your next project as a Scientist MSAT Advanced Therapies, where you will act as a critical Subject Matter Expert in USP and/or DSP for commercial manufacturing of lentiviral vectors, driving technology implementation and life cycle management for an iconic global healthcare company.

Roles and responsibilities
The Scientist MSAT Advanced Therapies is responsible for leading and/or supporting Life cycle management, technology transfer and/or technology implementation projects. The Scientist MSAT Advanced Therapies acts as Subject Matter Expert in USP and/or DSP for commercial manufacturing of lentiviral vectors and communicates with different stakeholder departments.

Contribute to LCM/New Technology Introduction for the Site

Lead and/or support Life Cycle Management projects

Lead and/or support technology transfer projects

Lead and/or support introduction of new technologies and digitalization projects

Act as Subject Matter Expert in USP and/or DSP for commercial manufacturing of lentiviral vectors

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 organisation

Capable of leading and supporting complex investigations, facilitation of risk assessments and defining appropriate corrective and preventive actions

Defining and implementing process improvements

Act as SME during internal and external audits and inspections

Represent Sassenheim MSAT in global project teams

How to succeed

7+ years of progressive experience with a BSc in Chemical Engineering/Biotech/Biochemistry (or 4+ years with an advanced degree: MS/MBA/Ph.D.)

Excellent 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 (analytical) technology and digitalisation of manufacturing

Delivers local as well as regional small projects, global project work streams or departmental programs successfully under limited supervision.

Selects applicable engineering/scientific tactics.

Manages multiple moderate size projects.

Works effectively as part of a team

Coaches and trains others

Supports in defining department, project and/or program goals and tactics.

Defines objectives to achieve targets on a team and/or individual level

Troubleshoots more complex problems and suggests effective resolutions

Effectively communicates with business partners to understand and explain business and technical issues

Functions independently with limited work direction

Provides direct input to budget and resource planning

Skills in communication, planning, documentation practices, risk management, root cause problem solving and knowledge management

Fluent in written and spoken English

Benefits

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

Diversity, Equity & Inclusion
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.

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