Senior Analytical Project Manager for Gene Therapy in CMC
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Måløv
Are you ready to take charge and make an impact on a range of early phase development projects? And to have an impact on shaping how we work with Gene Therapy in CMC? This is a relatively new and exciting therapy area that involves working with high skilled colleagues in Denmark and a range of international partners across the globe.
Are you prepared to leverage your project management expertise and analytical development skills in a dynamic organization where you'll be pushed to grow and expand your capabilities to the fullest? Are you seeking to join a team of energetic and highly skilled analytical project managers?
We are searching for experienced Analytical Project Managers to drive our gene therapy portfolio. We lead analytical development across a variety of technology platforms, molecule sizes and types within drug substance development, and injectable and oral drug products.
If you possess the relevant project management and analytical development skills, apply now and step into a challenging and rewarding opportunity.
The position
You will be a member of the CMC Project Core Team, where you will be responsible for planning and coordinating development activities within your area of expertise, ensuring timely deliveries.
You will interact with a wide variety of stakeholders such as Analytical departments, other CMC project managers, Global Research, Pilot plants, Product Supply, Quality Assurance and Regulatory Affairs. Within the gene therapy portfolio, we primarily use CMO’s for CMC activities.
As Analytical Project Manager you will be responsible for: Overseeing project management of analytical development, characterization activities and analytical strategies related to starting materials, drug substance and drug product. Guiding projects through different stages of clinical development in collaboration with internal stakeholders and contract manufacturers. Leading the analytical project team in a compelling and inspiring manner incl. setting direction for the development of regulatory applications and various internal and external documents. Coordinating the transfer of analytical methods from our research unit to CMC Development and further on to our manufacturing unit Product Supply or to a contract manufacturer. Qualifications
Your contribution to our department and to will be valuable due to your: Extensive experience in leading analytical activities in early and/or late phase clinical development. Scientific knowledge within analytical development for plasmid DNA production, AAV vector production, mRNA in vitro transcription and LNP production. Regulatory submission experience and ideally experience in working with Contract Manufacturing Organisations (CMOs). A relevant academic degree in Pharmacy, Chemistry, Biology, Engineering, or a related field. Proficiency in English at a professional level. While we welcome candidates of all nationalities, work will mainly be based in and out of Denmark, necessitating a willingness to relocate to Denmark.
About the department
Your new department, CMC Analytical Development and Characterisation - Project Office, consists of app. 40 employees located in Måløv. The department is involved in early and late-stage drug substance and product development, with emphasis on analytical development and chemical and biological characterization of new entities moving through the clinical development phases.
Working at
At , we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Senior Manager Taus Laurent Meincke at
Deadline
6 March 2024 Applications will be reviewed continuously, and interviews will be conducted during the posing period, so please do not hesitate to apply.
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Are you prepared to leverage your project management expertise and analytical development skills in a dynamic organization where you'll be pushed to grow and expand your capabilities to the fullest? Are you seeking to join a team of energetic and highly skilled analytical project managers?
We are searching for experienced Analytical Project Managers to drive our gene therapy portfolio. We lead analytical development across a variety of technology platforms, molecule sizes and types within drug substance development, and injectable and oral drug products.
If you possess the relevant project management and analytical development skills, apply now and step into a challenging and rewarding opportunity.
The position
You will be a member of the CMC Project Core Team, where you will be responsible for planning and coordinating development activities within your area of expertise, ensuring timely deliveries.
You will interact with a wide variety of stakeholders such as Analytical departments, other CMC project managers, Global Research, Pilot plants, Product Supply, Quality Assurance and Regulatory Affairs. Within the gene therapy portfolio, we primarily use CMO’s for CMC activities.
As Analytical Project Manager you will be responsible for:
Your contribution to our department and to will be valuable due to your:
About the department
Your new department, CMC Analytical Development and Characterisation - Project Office, consists of app. 40 employees located in Måløv. The department is involved in early and late-stage drug substance and product development, with emphasis on analytical development and chemical and biological characterization of new entities moving through the clinical development phases.
Working at
At , we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Senior Manager Taus Laurent Meincke at
Deadline
6 March 2024 Applications will be reviewed continuously, and interviews will be conducted during the posing period, so please do not hesitate to apply.
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Information og data
Denne ledige stilling har jobtypen "Projektleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Måløv.
Jobbet er oprettet på vores service den 21.2.2025, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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