id: NDk4MDE2NSA3

reference: 4980165

documentId: 4980165

connectionPointId: 7

lastModificationDate: 1556541024840

stillingsbetegnelse:
Principal Pharmaceutical Expert/scientific CMC adviser for Pharmaceutical Product Support

jobbeskrivelse:

Are you passionate about improving lives of millions of people by supporting all our marketed products?

This is your chance to join one of the world’s leading companies within dermatology and to set your mark on the quality of life for millions of patients around the world. Global Research and Development in LEO Pharma devotes its efforts to develop innovative drugs for the treatment of skin diseases like psoriasis and eczema. LEO Pharma is dedicated to bringing new treatment solutions within dermatology to patients and we aim at developing more user-friendly solutions for patients applying topical drug products.
You can look forward to becoming a part of a team with high professional standards in an informal atmosphere.

An interesting job with multiple aspects

As a Principal Pharmaceutical Expert/Scientific CMC adviser you will work closely with your colleagues on interdisciplinary projects within the LEO organisation both in Denmark and internationally. Along with your colleagues, you will offer support and analyse strategies for scientific CMC on formulation, primary packaging and stability, in addition take on responsibility to maintain CMC documentation for our marketed products. The established product portfolio is manufactured by different LEO Pharma manufacturing sites or different contract manufacturing organisations.
As Principal Pharmaceutical Expert you will be responsible for:

• Give CMC scientific advice to colleagues and other stakeholders
• Review Module 3 documentation for registration in connection with various maintenance and optimisation projects and provide advise during the writing process of the module 3 documents for both drug substances and drug products
• Write the Quality Overall Summary (QOS) and ensure consistency throughout the CTD Module 3
• Prepare CMC strategy for applications for regulatory variations to established products
• Prepare CMC strategy for how to answer CMC questions from authorities and review of same
• Write Quality Expert Statements (QES) for renewals
• Involvement in and partly responsible for Tech Transfer of API´s
• Participate in cross-organisational projects in Denmark and at our sites outside Denmark or in close collaboration with our CMO´s
• Coordination or participation in ad hoc tasks, e.g. root cause investigations and organisational optimisation projects (continuous improvements)

Great opportunity within Pharmaceutical Product Support

In Pharmaceutical Product Support we provide an interesting opportunity to use your expert knowledge and experiences to make a difference for the patients using topical products.
Pharmaceutical Product Support is part of Global R&D, counting 40 persons divided into three departments. We provide fast, efficient and qualified pharmaceutical, and analytical support documentation for all marketed products at LEO Pharma. You will join 15 colleagues in the department CMC MA Support in Pharmaceutical Product Support. Our focus is to do scientific support for all marketed products in LEO Pharma. We are enthusiastic and dedicated people. Our values are courage, impact, trust and mutual respect and helpfulness – and we care about each other. 
Together we will make sure that your professional competences will be put to use and we will give you great opportunities for further personal and professional development. We will look very much forward to get you on board in our joint efforts towards helping people achieve healthy skin.

Experienced person with passion and drive

You have 10+ years of experience with different aspects of pharmaceutical registration documentation, both from a scientific and a CMC regulatory perspective, or experience with CMC from within Competent Authorities. You hold a Master of Science or a PhD in Pharmacy, Engineering, Chemistry or likewise. 
As a support area, Pharmaceutical Product Support receives many unforeseen and urgent enquiries, and you must therefore be able to juggle a number of tasks and work on several projects at the same time. 
You will thrive in Pharmaceutical Product Support if you:

• demonstrate a can-do attitude
• are responsible, flexible, and a competent decision-maker
• are service minded
• have strong collaboration skills
• are proficient in English – both spoken and written
• work independently and systematically
• enjoy knowledge sharing with your colleagues
• support your close colleagues to meet project deadlines
• are good at switching between tasks in long term projects and tasks with short deadline
• An add-on if you have project management skills and/or LEAN experience
• It is also an add-on if you have experience working with API´s

 

Further information?

Please be aware that due to the collaboration with CMO´s, CRO’ s and other LEO production sites up to 4 weeks per year of travelling can be expected.
Please do not hesitate to contact Senior Manager Birgitte Wenzell Olesen, +45 25 66 41 17 if you want to know more about the position. 
We look forward to receiving your application. Deadline is May 15th, 2019. 
Job interviews will be held on a continuous basis.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C3213

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: LEO PHARMA A/S

source: DK-STAR