- Providing guidance and direction for transfer projects to new and established CMO's
- Participating in different expansion project and establishing clear roles and responsibility within the department, the CVP area and towards our stakeholders, ensuring effective use of all specialist resources
- Safeguarding the quality and compliance consideration in the work with our CMO's
- Preparing standards and strategies for existing and future CMO collaboration
- Execution of validation and tech transfer protocols and reports
- MSc Degree or equivalent in science, engineering, pharmacy, or another similar field
- At least 5 years of experience in the pharmaceutical industry within e.g. aseptic production, formulation, filling, and inspection
- Experience with outsourcing to CMOs as well as LEAN mindset will be considered an advantage
- Excellent communication and collaboration skills combined with scientific approach to challenges
- Professional proficiency in English
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Specialist in Validation and Technology Transfer - Søborg, Danmark - Novo Nordisk A/S
Beskrivelse
Are you ready to take on a new challenge and make a significant impact on Novo Nordisk's bottom line? Would you like to set direction and collect knowledge in a newly established department? Do you enjoy collaborative work in an international environment?
If so, we are looking for a talented individual to join our newly established "CMO and Expansion Projects" department as a Specialist in Validation and Technology Transfer. If you are ready to take on a new challenge read on and apply today for a life-changing career
The position
As a Specialist in Validation and Technology Transfer for CMO and Expansion Projects, you will be part of impactful projects that are global, cross-functional, and of strategic priority. You will work closely together with project managers and other specialists both within and outside the company. You will operate as general specialist covering product quality, production process and practical testing strategies.
Your primary tasks will include:
Moreover, you will be tasked with ensuring strong collaboration with a broad group of stakeholders. You will establish a tech transfer knowledge base in the department and have the opportunity to leverage your collaboration skills in a global setting. Stakeholder management has a central role in this position, providing you with key chance to expand your network across Product Supply within different areas of expertise and different organizational levels.
Qualifications
We are looking for someone who can build up knowledge of our process and requirements around tech transfer to CMOs. Our ideal candidate can work closely together with project team members and stakeholders.
To succeed in this role, you have:
Additionally, you have a high integrity and resilience that enables you to incorporate different views in the decision-making process.
On a personal level, you have a high degree of energy, drive, and willingness to make a difference. You communicate and collaborate with empathy across cultures and functions. Moreover, your behavior fosters positive interactions with colleges and stakeholders making you a great team player.
About the department
Injectable Finished Products (IFP), Site Support & Improvements (SS&I) is a dynamic VP area, consisting of 150 employees. The area provides site support and drives improvement and expansion projects of diverse complexity across our global production network. A high level of product knowledge and process understanding is anchored in the area.
As specialist, you will be part of a newly established department "CMO and Expansion Projects". A project department that supports the integration of new CMO's and other expansion programs into the IFP Manufacturing Development (IFP ManDev) area. This includes projects related to initial assessments and tech transfer to new CMO's and projects related to establishment of new aseptic filling facilities.
The success of the department has impact on the speed, success rate and overall ability for Novo Nordisk to expand the production capacity, hence a significant impact on the overall Novo Nordisk's bottom line.
