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Senior Supervisor Quality Control NPI - 2406200139W

Description

Janssen Biologics is currently recruiting a NPI Senior Supervisor Quality Control within our Quality department. The successful candidate needs to have QC testing, analytical method transfers and people leadership experience in the biologics/ pharmaceutical/ manufacturing industry with a relevant educational background. The candidate is accountable for managing a part of the personnel of the New Production Introduction (NPI) team, which is composed of several (associate) Analysts and associate Scientists engaged in transferring analytical methods and new technologies to ensure compliance with quality standards and product readiness for commercial supply.

Janssen Biologics B.V. is part of Johnson & Johnson Innovative Medicine. Janssen Biologics B.V. is a multinational pharmaceutical company that has been for more than 25 years a leader in the field of biomedicines. Through the dynamic science of biotechnology, we continue to seek innovative ways to treat cancer, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders (I.M.I.D.s), such as rheumatoid arthritis and psoriasis. Janssen Biologics is part of the Johnson & Johnson family of companies.

The Leiden Quality Control Leiden department is a Business Unit within the Leiden Janssen Biologics site, a biotherapeutics and advanced therapies manufacturing site that is part of the Janssen Supply Chain. The Leiden QC Large Molecule department is responsible for raw material, in-process and release testing for products manufactured at the site. Additionally, the Leiden QC LM department has a unique global responsibility and exposure by being the stability testing hub for large molecule products within Janssen Supply Chain, and by partnering with multiple CMOs to perform the release testing. The department is structured in different testing laboratories and supporting teams, which are divided based on specific techniques and/or expertise. All test laboratories are augmented by the NPI team, which leads and facilitates the introduction of multiple new products through deep expertise on the analytical method transfer process and effective communication between global stakeholders (e.g. AD, PQM, EQ, MSAT, CMC) and Leiden QC. The NPI team leads the introduction of Phase 1-3 NPIs and commercial NPIs into the QC department, and the method transfers required for commercial products and in-country testing to meet PPQ and commercial filing timelines. Besides support to Large Molecule, the NPI group also supports the QC Advanced Therapies department. The QC NPI Sr. Supervisors reports to the QC NPI Manager.

The responsibilities & the impact YOU will have:

• Lead a team of direct reports of 8-12 (associate) Analysts and associate Scientists.

• Manage implementation/ transfer of test methods, new technologies, training, and procedures.

• Ensure the NPI team members are subject matter experts on NPI processes and has a leading role during the GMP inspections.

• Maintain oversights over the analytical method transfer standards.

• Support QC readiness for onboarding new modalities, from a capacity and capability perspective.

• Mentor, coach, train and develop the personnel of the NPI team.

• Evaluate performance and provides opportunities for growth.

• Ensure overall compliance to regulatory cGMP requirements, global standards, procedures, etc.

• Performs other work-related activities assigned by the QC NPI Manager

• Act as a backup for the QC NPI Manager

Qualifications

We would love to hear from YOU, if you have the following essential requirements:

• Master degree in chemistry & biotechnology or equivalent by experience with minimal 6 years’ experience in the pharmaceutical industry.

• Experience in Quality Control, Method development, validation, etc.

• Experience in New Product Introduction

• Profound knowledge of pharmaceutical regulations/cGMP principles (FDA, EU, JPN, etc.)

• General knowledge of pharmaceutical development & manufacturing

• Organizational planning and problem-solving experience

• Strong leadership & development qualities

• Experience with principles of Process Excellence, Lean manufacturing, etc.

• Good presentation skills

• Excellent knowledge of English

• Experience in managing people (direct report lines, or indirect e.g. projects)

• Strong Quality Awareness

• Accurate and analytical mindset

• Team player, and ready to take a stand when necessary.

This is what awaits YOU at J&J

This is an opportunity to work with a highly motivated team and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement. We are passionate about our work; we play vital roles across a range of professional subject areas and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. Whether you’re one of the 2000 people who work here, or you’re considering joining the team, we offer:

• Flexible working hours

• Your chance to be part of a global market leader

• A dynamic and inspiring working environment

• Opportunities to work on exciting projects and assignments

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Please note that due to the holiday period this role will be open for application until midnight on Sunday 11th August.

Primary Location Europe/Middle East/Africa-Netherlands-South Holland-Leiden

Organization Janssen Biologics (7266)

Job Function Quality Control

Req ID: 2406200139W