Lab Director, Large Molecules Drug Substance

6 maanden geleden

Leiden, Nederland Johnson & Johnson Voltijd

Johnson & Johnson is currently seeking a **Lab Director, Large Molecules Drug Substance, Manufacturing Sciences and Technologies **to join our Manufacturing Sciences and Technologies organization located in Leiden.

**Responsibilities**
- Leads laboratory operations and leads the laboratory expansion efforts, including scheduling and coordinating of execution.
- Responsible for recruitment and development of MSAT staff, ensuring effective utilization of resources through strong leadership, performance management and robust employee development plans.
- Leads and mentors the process sciences team of scientists and technicians, including setting performance expectations and providing feedback.
- Anticipates needs and plans for the purchase, use, and maintenance of laboratory equipment.
- Sets priorities for experimental work to ensure adequate progress of team projects and objectives.
- Leads alignment on the priorities and needs between the process engineers, TLIs, TOs and technicians in the MSAT team.
- Ensure that changes to existing processes or the introduction of new processes are carried out and documented according to approved change control procedures and in compliance with cGMP requirements.
- Contributes to the design and execution of small-scale experiments during process characterization activities and complex investigations, having direct impact on the analysis of highly complex issues.
- Leads the implementation of small-scale models within the MSAT lab.
- Ensure accurate records of experiments and compliance with relevant quality and regulatory requirements.
- Promote a continuous improvement mindset to identify and implement improvements in the MSAT and laboratory processes and procedures.
- Has direct people management responsibility.
- Review and monitor data management process to ensure that records are properly documented and shared internally.
- Actively partners with R&D functions to translate process development knowledge into Manufacturing Science and Technologies processes.
- Is knowledgeable of health authorities latest guidelines and policies regarding drug substance biologics.

**Nature of Communication**
- Communicates overall strategy and results of the projects to others.
- Serves as the liaison between team members and senior leadership.
- Influences across disciplines with senior leaders and external partners to drive and align strategic and operational scientific activities between business functions.
- Negotiates and solicits acceptance of new ideas, approaches, concepts through scientific leadership.

**Program/Project Management**
- Has direct responsibility for budget and resource allocation on a project.
- Sets and monitors priorities, budget, timeline and resources for team.
- Influences the initiation, development and termination of projects in a timely manner.
- Directs the proper use and implementation for new technology to remain competitive.
- Advises on current procedures and assesses potential improvements across products and processes.

**Qualifications**:

- A Minimum of 10 years of experience in Drug Substance pharmaceutical development or pharmaceutical manufacturing or related post graduate academic experience/education is required and people leadership experience.
- Proven track record in leading technical/scientific team(s) and direct people management experience.
- Excellent written and oral communication skills and ability to influence peers, superiors, and partners is required.
- Primary in-depth experience in protein pharmaceutical development is needed including large molecule process development and analytics and proven experience in CTA and BLA authoring.
- Excellent interpersonal skills with the ability to adapt effectively to manage a growing portfolio. Motivated, self-starter able to work independently with demonstrated problem solving skills is required.
-

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

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