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Pharmaceutical Specialist

 
Requistion ID:  1915
Location: 

Copenhagen, Hovedstaden, DK

Date:  05-Jun-2021
 

Pharmaceutical Specialist (Project Manager), Pharmaceutical Development

Lundbeck’s passion links to our purpose about restoring brain health so every person can be their best. We strive to make a real difference to patients. By developing innovative treatments, we improve the lives of people living with brain diseases. Your dedication is crucial. That is why you can expect us to be committed to your progress, so you can stay committed to ours.

Would you like to develop new small molecule drug products for the treatment of brain diseases globally? Do you enjoy taking the lead in planning and execution of CMC and formulation activities and related complex scientific challenges in a dynamic environment where we work with agility and risk-based decision making? Then you may be our new Pharmaceutical Specialist

 

Description

We are currently looking for an experienced Pharmaceutical Specialist with a strong scientific background within early phase formulation development, preferably within multiple types of dosage forms and with a project manager mindset for a position in Pharmaceutical Development.

The right candidate will have a strong scientific background and experience with working with CMC development activities as well as formulation development activities in early clinical development phases.

In Pharmaceutical Development, we are currently 14 highly skilled and passionate colleagues who are responsible for pharmaceutical development and supply of Investigational Medicinal Product (IMP) of small molecules in phases spanning from pre-IND stage to transfer to commercial validation. You will be part of this dynamic team, as well as an active member of the CMC project teams.

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.

 

Your job and key responsibilities  

The job contains two primary roles:

 

CMC Project Manager, where you will be leading CMC project teams and task forces, and represent CMC in the global R&D project teams.

The tasks in this role include:

  • Leading the CMC project team, including setting CMC strategies, ensuring cross functional collaboration on the project, stakeholder management as well as creating development plans, and managing the project budgets.
  • Be part of the global R&D project team, where you will be using your scientific background and strategic understanding of drug product development when participating in setting the right product strategy for the projects

 

Formulation Scientist, where you will be scientific lead on formulation development on various projects in the pipeline.

The tasks in this role include:

  • Taking the scientific lead on early phase formulation development activities, e.g. establish the formulation strategy and lead formulation experiments in internal or external labs.
  • Leading the subsequent IMP manufacturing activities in collaboration with CMOs
  • Support sharing of knowledge and data as well as increase cross organisational collaboration in the early development phase of the projects.
  • Working on our development projects together with colleagues from areas like Process Chemistry, Solid Form Science and Analytical Development. In collaboration with the CMC 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 use and regulatory purposes

 

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.

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 an excellent understanding and proven scientific skills (5+ years) within early phase pharmaceutical development. You possess drive and a positive mindset, embrace challenges, and can inspire your colleagues and the teams you work in, even when facing obstacles
  • Extensive experience with project management, demonstrated capability of leading project teams and problem-solving skills with the ability to manage multiple projects with changing priorities
  • Experience with collaborations with CMO’s
  • 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 as 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. Your application and CV should not be sent via email.

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

 

Your application

Please click on the link below to apply for the job. Applications will be reviewed on an ongoing basis and must be received no later than 20th July 2021. Your application should include a cover letter stating your experience and motivation for the position and curriculum vitae.

 

 

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.