Principal API Specialist
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Ballerup
Do you have a passion for working with process chemistry?
We are looking for a Principal API scientist with a strong laboratory focus and solid track record in downstream process chemistry, working across pharma manufacturing and API process development on the optimization of synthetic routes and crystallizations.
If you like being part of a very informal, collaborative, and diverse team in a company that is experiencing the most exciting period of development ever, then join Global Manufacturing Science and Technology at LEO Pharma!
You will enter LEO Pharma at a time of significant change. Right now we are transforming the business to meet the requirements of tomorrow.
To fulfil our goal of becoming the world’s preferred dermatology care partner we have embarked on a new journey with focus on building a small molecule pipeline in-house and launching new products or indications every 2-3 years. When joining Global Manufacturing Science and Technology, you will be a key team member in both ensuring successful operation of current API production and building the capabilities to receive and launch new products from the pipeline.
In Global Manufacturing Science & Technology (MSAT) you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.
The job
As principal API specialist the overall objective is to support LEO Pharma’s API manufacturing operation in Global Product Supply (GPS) - using science, statistical tools, novel technologies and a collaborative approach. This applies both for current manufacturing processes to ensure robust processes with high yields and in the development of new manufacturing processes.
Your key tasks include:
- Act as Subject Matter expert (SME) for Global MSAT in the field of process chemistry.
- Lead scale up and scale down work at laboratory, pilot and production scale
- Plan and lead experimental work in the Global MSAT Chemistry Laboratory using tools such as Design of Experiments (DoE) and Quality by Design (QbD) approach, process analytical technology (PAT), statistical analysis and multivariate data analysis (MVDA).
- Participate in hands-on work in the Chemistry Laboratory including training of colleagues and students.
- Lead and/or Participate in trouble shooting activities e.g. root cause analysis
- Participate in test productions, Process risk assessment and Process validation work
- Active member of the Global Scientific Cluster on Crystallization – an engaged cross-functional team with participants from R&D and GPS.
- Cross-functional collaboration with projects, key stakeholders and production departments.
You will be based at the LEO headquarters in Ballerup, with a flexible work set-up offering possibilities for working partly remote.
Your qualifications
- MSc or preferably PhD degree in Chemistry or related field with solid experience in process chemistry, and minimum 10 years of experience within the pharmaceutical industry or similar, such as food or chemical industry.
- Solid experience with cross-functional collaboration and project work is preferred
- Excellent knowledge and experience with scale up and scale down of chemical processes.
- Experience and understanding of drug substance development and production processes in a GxP environment including preparation of regulatory documentation.
- Experience with DoE and QbD, statistical analysis and multivariate data analysis..
- Preferable experience with Tech Transfer and CRO/CMO collaborations
- Preferable experience with HAZOP analysis
- Preferable experience with PAT instruments and spectroscopy e.g., FT-NIR, Raman, FBRM etc., and model development, validation, and implementation in GxP environment.
- Knowledge of reaction monitoring and kinetics is an advantage
- Strong verbal/written communication & presentation skills.
- Ability to deal with ambiguities and competing priorities.
- Healthy sense of humor and open to work in a diverse department with many other highly skilled employees.
You are self-driven and curious and will be expected to challenge existing practice and develop proposals to enhance existing processes and knowledge. You have an outgoing and positive can-do attitude and feel confidence working on your own but also enjoy collaborating with colleagues across the LEO organization.
Your new team
You will part of the Global MSAT Chemistry Laboratory together with one other Principal Scientist, a Chemist and 2 Technicians. You can look forward to be part of a team that believes that diversity, knowledge sharing and an open and collaborative working environment is an important foundation for being successful in our tasks.
You will also be part of a cross-functional Global MSAT team of highly skilled and dedicated specialists with the overall aim to continuously support and improve our manufacturing processes and insure long term manufacturability.
Join our mission to help more people achieve healthy skin
Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.
By joining LEO Pharma you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.
Contact and application
If you have questions, please do not hesitate to contact Helle Birgitte Hansen, Manager at + 45 4130 1681.
.
About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 6,000 people worldwide. For more information, visit www.leo-pharma.com.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 24.3.2022, 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.
- Øvrige
- Ballerup
- Søndag den 10. april 2022
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