CMC Consultants
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Kongens Lyngby
PharmaRelations is a Swedish owned and leading company that provides qualified interim services and recruitment within Life Science in the Nordics. We have a passion for growing and developing people and companies. The culture of ‘PR’ is based on our values developed by our staff. There is an entrepreneurial spirit here, we have high ambitions with a clear focus on growth and results. At the same time, we have a warm and unpretentious work climate based on participation and short decision-making paths.
PharmaRelations is growing and we have a great demand for consulting services. We are currently looking for a senior CMC consultant and a junior to mid-level experienced CMC consultant located in Sweden or Denmark.
Your professional qualifications
Senior Regulatory CMC – consultant
You have a university degree in science, preferably a doctor’s degree, with 10+ years of experience from the pharmaceutical industry within CMC (Chemistry, Manufacturing & Control) for pharmaceuticals and/or biologic products and are used to planning, setting up and running your work independently.
The requirements for this role is writing and reviewing module 3 sections of drug substance and drug product for IND/IMPD/MAA/BLA submissions, writing and reviewing CMC development reports consisting of e.g. process development, analytical and formulation development, managing method development and analytical validation of e.g. HPLC methods, cGE and bioassays, managing process validation activities of drug product manufacturing process, evaluating drug substance and drug product stability data and prepare justification of specification limits of drug substance and drug product and writing quality documents/SOPs. You will be participating in advisory meetings and experience from authority is therefore an advantage. You are fluent in English, both in writing and verbally. Preferably also fluent in Swedish and/or Danish.
You have a passion for your work, are good at seeing the big picture and prioritizing. The person we are looking for must have the ability to establish confidence in our client and have very good communication skills.
CMC Regulatory – consultant
You have a university degree in science, with at least 3-5 years of experience from the pharmaceutical industry within CMC. In this role, you will be CMC responsible in product development projects and independently and in collaboration with others in the team run and coordinate projects and investigations. This can also mean compiling CMC documentation in e-CTD format and handling both Module 2 & 3 documents in close collaboration with Subject Matter Experts. You will also need to compile formulation studies and physicochemical experiments and analytics, to write and review guiding instructions and quality documentation in the field. You should therefore be able to critically review, interpret and write documents, both regulatory and scientific.
You are fluent in English, both in writing and verbally. Preferably also fluent in Swedish and/or Danish.
Wat do we offer you
We offer a workplace were your contribution is important and visible as we all take responsibility for our own development as well as PharmaRelations. Within our company you have great opportunities to develop yourself by different tasks and assignments over time.
Your application
Are you who we are looking for and do you have an action-oriented personality with a passion to grow, together with colleagues in a flexible work environment?
Show courage and be active to apply as applications are processed continuously.
Fore more information about the assignments, please contact:
Shiva Hobbi Nowzari
Consultant Manager, Medical Interim Services
Sweden
+46 70-165 22 64, email: [email protected] or
Louise Brinking
Medical Talent Manager
Denmark
+45 5376 9570, email: [email protected]
Due to GDPR we cannot receive any applications by email, so please submit your CV at www.pharmarelations.se
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Kongens Lyngby.
Jobbet er oprettet på vores service den 5.2.2021, 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
- Kongens Lyngby
- Søndag den 04. april 2021
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Statistik over udbudte øvrige i Kongens Lyngby over tid
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