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Pharmaceutical Specialist, Pharmaceutical Development

 
Requistion ID:  1403
Location: 

Copenhagen, N/A, DK

Date: 
 

Pharmaceutical Specialist, Pharmaceutical Development

Would you like to be a part of developing new pharmaceutical drug products in Lundbeck’s pipeline? Do you enjoy taking the lead in planning and executing formulation activities and related complex scientific challenges in a dynamic environment? Then you may be our new Pharmaceutical Specialist.

 

Description

We are currently looking for an experienced pharmaceutical specialist for a new position in Pharmaceutical Development. 

The right candidate will have a strong scientific background in early phase formulation development and biopharmacy, and experience working with formulation development activities in early clinical phases as well as external GMP manufacturing of Investigational Medicinal Product (IMP) for clinical trials.

Pharmaceutical Development is part of the CMC area where we strive to develop new innovating treatments to help improve the lives of patients suffering from brain diseases.

In Pharmaceutical Development, we are 14 highly skilled and passionate colleagues who are responsible for pharmaceutical development and GMP supply of Investigational Medicinal Product (IMP) of small molecules in phases spanning from pre-IND stage to transfer to commercial validation.

 

Your job and key responsibilities  

Formulation development activities are carried out in a balanced approach between internal and external capabilities, and we work with external CMOs to support GMP supplies of bulk IMP for clinical trials.

You will be part of a dynamic team, responsible for the formulation development and IMP supply on development projects, as well as an active member of the CMC project teams. As part of the CMC project teams, you will use your scientific background and strategic understanding of drug product development in setting the right strategy for the projects.

Your essential tasks include:

  • Taking the scientific lead on early phase formulation development activities, e.g. stablish the formulation strategy and lead formulation experiments in internal or external labs.
  • Leading the subsequent IMP manufacturing activities in collaboration with CMOs.
  • Participate in strengthening the link between preformulation and human formulation development, including biopharmaceutical assessments and supporting formulation strategies.
  • Support sharing of knowledge and data as well as increase cross-organizational collaboration in the early development phase of the projects.
  • Being part of CMC focus teams together with colleagues from areas like Process Chemistry and Analytical Development. In collaboration with the project team you will be responsible for progressing our development projects and you will contribute with pharmaceutical expertise to find the right strategy for the individual projects.
  • Ensuring flexible planning and coordination of drug product related tasks and matching the shifting project demands over time, including scenario planning, in close collaboration with colleagues across the internal organization and in collaboration with CRO/CMO’s.
  • Prepare documentation both for internal and regulatory purposes.

 

The job will require you to have highly developed scientific understanding and skills and that you are able to solve complex scientific challenges in an agile environment where we apply external and internal knowledge on an ongoing basis. You will work with a wide variety of exciting activities in close collaboration with colleagues in your internal and external team and across the organization.

 

Qualifications 

Our preferred candidate has the following personal and professional qualifications:

  • You hold a PhD or a MSc within pharmaceutical science, engineering or another relevant scientific discipline.
  • You have excellent understanding and proven scientific skills (3-5 years) within early phase pharmaceutical development, and you strive to set a high scientific standard.
  • Experience within biopharmacy and understanding the link between preclinical data, clinical data and formulations is a clear advantage, including knowledge of PBPK modelling e.g. GastroPlus.
  • You possess drive and a positive mindset, embrace challenges, and can inspire your colleagues and the teams you work in, even when facing obstacles.
  • Experience with project management, demonstrated problem-solving skills with the ability to manage multiple projects with changing priorities.
  • Experience with collaborations with CMO’s and GMP manufacturing.
  • Work in a structured manner, introducing innovative solutions as needed.
  • You have a good understanding of CMC development, and in-depth experience with the corresponding drug product documentation.
  • You have experience with a broad variety of development activities, are result-oriented and able to manage problem solving in a structured manner and find innovative solutions if needed.
  • You possess creative and strategic skills to solve complex scientific challenges in an environment where prerequisites and timelines change rapidly.
  • You are fluent in spoken and written English.

 

The position level will be adjusted based on assessment of the applicant competencies.

 

Further information

For further information, please contact Director of Pharmaceutical Development Kirstine Høeg-Møller on KIRB@lundbeck.com or +45 30 83 35 98.

Applications will be reviewed on and ongoing basis and must be received no later than 15.nov. 2020.

 

Your application and CV should not be sent via email.

We also recommend that you have a look at our website.

 

 

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.
 
Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.
 
Read more at www.lundbeck.com/global/about-us/progress-in-mind
 
Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com, and connect with us on Twitter at @Lundbeck and via LinkedIn.