Director for Aseptic Process

Fuldtid

Permanent

Vandtårnsvej 108, 2860 Søborg, Danmark

ID: 2668384

Indrykket for 55 dage siden

Are you an empathetic and empowering leader ready to bring your leadership career to the next level? Would you like to put your people management and stakeholder relations building skills to good use? If yes, you may be the Director we are looking for, to head up our Aseptic Process specialist team in Global Contract Manufacturing, Drug Product (GCM DP) External Manufacturing Technology and Optimisation (EMTO). We implement Novo Nordisk production processes of some of the key products at contract manufacturers across the world. The area handles high-profile products in Novo Nordisk with high expectations to solid growth in the coming years. Apply today and be part of this journey!

The position

As Director for Aseptic Process, your focus will be to lead a growing unit of 12 aseptic process professionals and specialists responsible for implementing new production at new or existing Contract Manufacturing Organisations (CMOs) within Drug Product aseptic process manufacturing. The team will likely expand further in the coming months and years, as the global footprint of CMOs is growing.

Your main responsibilities include:

Guaranteeing the focus on Drug Product tech transfer projects to external partners, acting as production responsible during project phase representing our external manufacturing sites internally in Novo Nordisk

Ensuring Subject Matter Expert (SME) support to Operations team for the production and release of the products from CMOs in Commercial phase, for example troubleshooting, problem solving, major/critical deviation investigation linked to manufacturing of Novo Nordisk products externally

Being a sparring partner for your people, while having a focus on empowerment

Collaborating closely with a broad range of stakeholders including Global Strategic Outsourcing unit, the management teams of the CMOs as well as other internal Novo Nordisk departments, covering e.g. Quality and Subject Matter Experts

Playing a pivotal role in setting the direction for CMOs in implementation phase with a focus on quality, facility and equipment as well as ensuring competences at the CMO are maintained

You will report directly to the Senior Director DP EMTO.

Qualifications

To be considered for this position, we imagine you:

Hold a master’s degree in chemistry, pharmacy, engineering or another relevant field

Have a strong leadership experience including managing academics/specialists

Possess a scientific background and some experience in at least one of the following: outsourcing of production, manufacturing development and/or operations, quality assurance, managing of internal production or equivalent

Familiar with GMP requirements within the pharmaceutical industry

Are fluent in English, both written and spoken

As a person, you thrive in engaging, motivating, and inspiring your employees to perform in a dynamic and international environment. You are there for your employees, you help ensure psychological safety in the department. You possess good communication skills and a structured approach, which allow you to gain commitment from both internal and external stakeholders. Finally, you have a strong quality mindset and the ability to make decisions.

About the department

Global Contract Manufacturing Drug Product (DP) EMTO is responsible for implementing new production at existing or new CMOs in the global network of DP CMOs in Novo Nordisk. We are responsible for the CMO facility, equipment and the production through process validation. We are currently engaged in more than 20 projects, including aseptic process filling in pre-filled syringes (PFS), Cartridges & vails and final assembly and pack. The number of projects is expected to grow heavily in the coming years. Our main task is, together with the CMO, to ensure that we transfer the production process, making the CMO ready for validation activities and ensuring the process is documented and finally approved. Thereafter we transfer the responsibility to our Operations manager colleagues and continue to support the production when issues arise.

You will join a department of 24 (and still growing) highly dedicated and talented colleagues, where we have an informal and direct tone and where we value each other’s differences.

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