Specialist in Validation and Technology Transfer

2 weeks ago

Søborg, Denmark Novo Nordisk AS Full time

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:

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


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:

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

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.

  • Specialist in Validation and Technology Transfer

    2 weeks ago

    Søborg, Denmark Novo Nordisk Full time

    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...

  • Advanced Quality Specialist

    2 weeks ago

    Søborg, Gladsaxe Municipality, Denmark Aeven AS Full time

    Advanced Quality Specialist (GxP) for our Application Lifecycle Management (ALM) TeamProfile Summary The Advanced Quality Specialist is responsible for ensuring the quality and compliance of the ALM Quality Center software, The Advanced Quality Specialist will perform various tasks related to validation, testing, release management, support, audit, training,...

  • Advanced Quality Specialist

    2 weeks ago

    Søborg, Denmark Aeven AS Full time

    Advanced Quality Specialist (GxP) for our Application Lifecycle Management (ALM) TeamProfile Summary The Advanced Quality Specialist is responsible for ensuring the quality and compliance of the ALM Quality Center software, The Advanced Quality Specialist will perform various tasks related to validation, testing, release management, support, audit, training,...

  • Senior Manager

    5 days ago

    Søborg, Denmark Novo Nordisk AS - VTx Full time

    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 one of the two Senior Managers we are looking for, both newly established positions, to head up our Global Contract Manufacturing, Drug...

  • Senior Manager

    2 weeks ago

    Søborg, Denmark Novo Nordisk AS Full time

    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 one of the two Senior Managers we are looking for, both newly established positions, to head up our Global Contract Manufacturing, Drug...

  • Senior Manager

    1 week ago

    Søborg, Denmark Novo Nordisk Full time

    The position As Senior Manager your focus will be to lead a growing unit of professionals and specialists responsible for implementing new production at new or existing Contract Manufacturing Organisations (CMOs) within Drug Substance. Your main responsibilities include: Overseeing a team of currently six highly educated and dedicated professionals and...

  • Senior Professional, Assembly

    1 week ago

    Søborg, Denmark Novo Nordisk AS Full time

    Are you enthusiastic about production and enjoy collaborating with numerous stakeholders, globally? Do you thrive in facilitating seamless coordination between our internal sites and Contract Manufacturing Organisations (CMOs) to uphold operational consistency? Then look no further, apply today and join our growing Global Contract Manufacturing (GCM)...

  • Senior Professional, Aseptic Process Drug Product MSAT

    1 week ago

    Søborg, Denmark Novo Nordisk AS Full time

    Do you have a passion for production and enjoy working with many stakeholders both internally and externally? Would you like to bridge the gap between our internal sites and our Contract Manufacturing Organisations (CMOs) to ensure consistency across our operations? Then look no further: apply today and join our growing Global Contract Manufacturing (GCM)...

  • Sterile Filtration Professional

    3 weeks ago

    Søborg, Denmark Novo Nordisk Full time

    The position As a Sterile Filtration Professional, you will be responsible for providing detailed knowledge of the filtration process and its interaction with our various products to a wide range of stakeholders. You will also use critical thinking to efficiently provide support in production-impacting cases. In your role as a product and process...

  • Principal CDR Specialist

    2 weeks ago

    Søborg, Denmark Novo Nordisk AS Full time

    Are you passionate about transforming the clinical data review into clinical data insights and ensuring data integrity and compliance with regulatory requirements? Do you have extensive experience in data management within the pharmaceutical industry? We are looking for a Principal Centralized Data Review Specialist to join our growing Clinical Data...

  • Principal CDR Specialist

    3 weeks ago

    Søborg, Denmark Novo Nordisk Full time

    The position The Principal CDR Specialist is expected to independently lead function level initiatives in Data Management & Centralizzed Data Review and across CDOI. This role is expected to be highly specialised in multiple business critical processes and systems and capable of applying this expertise across multiple highly complex trials. As a...

  • Manager for Formulation

    2 weeks ago

    Søborg, Gladsaxe Municipality, Denmark Novo Nordisk AS - VTx Full time

    Are you a people leader who is ready to advance in your career? Are you someone who can inspire and shape the future of aseptic manufacturing at Novo Nordisk? Do you thrive on making a meaningful impact through your team's success? Grab this opportunity to join a rapidly growing department where you as a leader will effectively set the direction and pace...

  • Data Governance Specialist

    4 weeks ago

    Søborg, Denmark Novo Nordisk AS - VTx Full time

    The position As our Data Governance Specialist, you will be part of the newly established Clinical Data Governance department in Clinical Data Operations & Insights. Based in Søborg, Denmark, you will report to the Vice President of Clinical Data Governance. With a potential background in pharma or banking, the ideal candidate will have a strong...

  • Statistical Specialist

    2 weeks ago

    Søborg, Denmark Novo Nordisk AS Full time

    Are you a highly experienced statistician looking for an opportunity to use your statistical knowledge and quality mindset to bring clinical projects to registration and market? Are you ready to work with our broad and expanding pipeline? Do you thrive in an inclusive, engaging, and global environment? Then, this is your chance to join our Biostatistics...

  • Data Science Policy Specialist in Regulatory Affairs

    1 week ago

    Søborg, Denmark Novo Nordisk AS Full time

    Do you want to work with policies and regulation on advanced data science capabilities and methodologies ? Do you enjoy working in a fast-changing environment where engaged people have a unique combination of scientific and technical insight and ability to navigate political agendas and external stakeholders? If yes, you might be the new Data Science...

  • CMC Project Director for Strategy Execution

    3 weeks ago

    Søborg, Gladsaxe Municipality, Denmark Novo Nordisk AS - VTx Full time

    Are you looking for an exciting opportunity within CMC project management and strategy execution in close collaboration with key stakeholders? Are you motivated by leading complex projects within growing therapy areas? Do you want to deliver visible footprints and utilize your excellent project leadership skills by setting the direction and motivate your...

  • Principal CDR Specialist

    3 weeks ago

    Søborg, Denmark Novo Nordisk Full time

    Are you passionate about transforming the clinical data review into clinical data insights and ensuring data integrity and compliance with regulatory requirements? Do you have extensive experience in data management within the pharmaceutical industry? We are looking for a Principal Centralized Data Review Specialist to join our growing Clinical Data...

  • Principal Project Manager

    2 weeks ago

    Søborg, Denmark Novo Nordisk Full time

    The position As a Principal Project Manager for CMO and Expansion Projects, you will be responsible of impactful projects that are global, cross-functional, and of strategic priority. You will work closely together with specialists and project managers both within and outside the company. Your primary task will include: Leading tech transfer projects...

  • Principal Project Manager

    2 weeks ago

    Søborg, Denmark Novo Nordisk AS Full time

    Are you a talented project manager and would you like to work with talented colleagues? Then this is your moment, as we are looking for senior project managers to join our new department “CMO and Expansion Projects”. So, do you want to lead strategic expansion projects with high impact for Novo Nordisk, and do you enjoy delivering in close cooperation...

  • Principal Project Manager

    1 day ago

    Søborg, Denmark Novo Nordisk AS - VTx Full time

    Are you a talented project manager and would you like to work with talented colleagues? Then this is your moment, as we are looking for senior project managers to join our new department “CMO and Expansion Projects”. So, do you want to lead strategic expansion projects with high impact for Novo Nordisk, and do you enjoy delivering in close cooperation...