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Serialisation Lead – Biologics and External Manufacturing

LEO Pharma A/S

Utilise your natural science skills in a job with great opportunities
If you have a science, IT or supply chain degree and you are looking for a job where you can bring all of your skills into play and at the same time have a steep learning curve, this is it. When you join our Biologics and External Manufacturing team you will be in the centre of one of LEO Pharma’s most important strategic focus areas. You will be a trusted adviser working closely with our Contract Manufacturers (CMOs) in ensuring that LEO Pharma’s products are delivered in compliance. No days will be alike when you turn challenges into solutions together with your highly skilled and dedicated colleagues in a very well-functioning team.

Ensure and guide serialisation at LEO Pharma’s Contract Manufacturers (CMOs)
Serialisation is a unique ID for each saleable unit of medicinal products to reduce the risk of counterfeit products to patients. Track and Trace throughout the supply chain from manufacture to patient can be part of the country specific requirements.

As the serialisation lead in Biologics and External Manufacturing, your most prominent objective is to uphold LEO Pharma’s license to operate within the serialisation area. You will do so by providing guidance and support to our CMOs and Biologics and External Manufacturing to ensure that LEO CMOs works according to the serialisation legislation.

You will be responsible of:

  • Provide general serialisation support within LEO Pharma and towards the CMOs
  • Contact to the CMOs regards serialisation issues incl. changes from onboarded markets
  • Serialisation onboarding of new markets and new CMOs
  • Coordinate any investigations of market alerts towards the CMOs
  • Participate in serialisation projects – e.g. future change of date format in 2D Data Matrix or onboarding of new market with complex serialisation set-up.
  • Handling of QMS records (customer complaints, deviations, CAPAs and change controls) related to serialisation issues and/or alerts
  • Serialisation procedures (e.g. SOPs, WIs and other written procedures) within Biologics and External Manufacturing
  • Participate in implementing corrective and preventive actions
  • Participate in our on-going optimisations of processes, methods and tools
  • Support compilation and reporting of performance metrics and KPIs

You can look forward to collaborating with multiple external partners and colleagues across the global organisation, especially our colleagues in the Internal Market Access and Quality department.

Natural science degree and experienced with serialisation and GMP

  • You have a background within science, IT or supply chain/planning. In addition to this:
  • The ideal candidate has experience within serialisation/aggregation, SAP (ATTP and pre-production) and HP test center
  • You must be able to navigate in an everyday life where tasks and plans are constantly changing
  • You must have the necessary quality mindset and you could bring experience related to GMP. This will naturally be an advantage but it is not a prerequisite for applying
  • You must have good communication and collaboration skills. You like to create results via constructive collaboration with due respect to cultural and professional differences
  • You must be comfortable asking questions in order to get the necessary understanding of e.g. a certain process
  • As part of a small team with great responsibility you must also like to be responsible for your own tasks – if you can’t solve a problem yourself, you can find a colleague that can
  • Being part of an organisation in transformation also calls for your ability to keep up the good spirit when things not turn out as foreseen

Your new team
You will join a small and agile team of three GMP Specialists in our Biologics and External Manufacturing organisation at the LEO Pharma HQ in Ballerup, Greater Copenhagen. Our team’s focus is to ensure high quality level of serialisation and GMP compliance with an understanding of commercial aspects and the reliability of product deliveries.

We share office with our approx. 20 colleagues in Biologics and External Manufacturing. Our common objective is to make LEO Pharma’s external manufacturing as intelligent and smooth as possible – naturally always in full compliance with legislation and requirements. We work in an open atmosphere of trust, helpfulness and fun.

We look forward to receiving your application.

About LEO Pharma
LEO Pharma helps people achieve healthy skin. The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 5,500 people, serving 76 million patients in 130 countries. In 2018, the company generated net sales of DKK 10,410 million. For more information, go to: www.linkedin.com/company/leo-pharma or www.leo-pharma.com

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Ballerup, Denmark

Helene Lyngby Nielsen

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LEO Pharma
LEO Pharma is on an exciting journey of transformation to become the world leader in dermatology. We keep the patients at the heart of everything we do, and we drive dermatology with our knowledge, collaboration and curiosity. We are at the forefront of science in developing new medicines for dermatology, and we are committed to helping people with skin diseases live more fulfilling lives.

Our people are united worldwide with strong core values and a common vision. Our shared vision and mission adapt to an ever-changing environment, while remaining true to our business strategy. Our values reflect the way we strive to increase the quality of life for patients.

Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions.

LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries.

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LEO Pharma A/S - hurtigt overblik

LEO Pharma A/S
LEO Pharma A/S
LEO Pharma develops, manufactures and markets pharmaceutical drugs to dermatologic and thrombotic patients in more than 100 countries globally.

Industriparken 55
2750 Ballerup
Logo: LEO Pharma A/S
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