Vacature Manager Chemical

Manager Chemical, Physical and Raw Material team QC Lab (temporary role, 8 months)

• Titel Manager Chemical, Physical and Raw Material team QC Lab (temporary role, 8 months)
• Functie Quality
• Sub functie Quality Control
• Locatie Leiden, South Holland, Netherlands
• Gepost feb 27 2024
• Referentie 24W

Beschrijving

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 https://www.jnj.com/.

As a part of the QC Lab situated at the Janssen Biologics Manufacturing site in Leiden, the Chemical, Physical and Raw Material (CPRm) testing team is responsible for execution of all chemical and physical testing using various techniques. The products tested ranging from early clinical up to commercial, covering process control, release and stability.

For our team, we are looking for an a.i. Manager that will lead the CPRm team for a period of 8 months. The key responsibilities of the jobholder:

Responsibilities & Accountabilities:

• Responsibility for the efficient and effective functioning of the team, ensuring (testing) activities are in line with the timelines, resources and budget.
• Onboarding (transfer/co-validating) several New Products
• Responsibility for the adequate qualified/ trained resources available for the (testing) activities needed in his/her team. Recruitment and hiring of personnel, ensuring proper onboarding and training.
• Escalating (OOS/OOT) investigations and assay performance issues.
• Operating with a flexible and sustainable team, able to absorb fluctuations to ramp up and down the testing to meet customer requirements and market demand.
• Accountable for the performance and act as a Servant Leader to coach and develop team members to become successful in talent development and business performance.
• Acting as change agent and build and maintain team capabilities to meet current and future needs
• Accountable for a smooth transfer to the new Laboratory areas including maintaining On Time Delivery during activities
• Setting goals and objectives for the department and define Key Performance Indicators that are indicative for excellent performance.
• Running the budget of the group and provide inputs for the OPEX and CAPEX budget
• Achieving innovation and excellence in business processes
• Ensuring that procedures and guidelines linked to safety, environmental and health are met.
• Ensuring that overall compliance to regulatory cGMP requirements, global standards, procedures, etc.
• Ensuring that data is generated and maintained according to current regulatory requirements, including data integrity
• Coordinating the inhouse services providers and their contract providing general assistance to the labs
• Sponsoring strategic and capital projects at departmental and site level.

Profile:

• Master degree in life sciences, chemistry, biotechnology or equivalent
• 8-10 years of proven experience in a Quality or related environment, of which 4 or more years in a people leadership position.
• Experience in Quality Control.
• Profound knowledge of pharmaceutical regulations/cGMP principles
• 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. is a pre.
• Good presentation skill
• Strong command of English
• Managing and leading a medium-large (40-50) size specialized group (8-10 direct reports)
• Personal and interpersonal skills: self-starting, informed decision making, analytical thinking, strong quality awareness and flexibility

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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