Principal Scientist for pilot development and clinical manufacture
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Hørsholm
Do you bring experience from working in the development area with drug substance operations and equipment qualification? Are you skilled in data processing and reporting? Join us on our exciting journey and become our new colleague in Pilot Facility and Equipment.
The position
We are about to start designing and qualifying new equipment for a new manufacturing process in our pilot facility for clinical phase II/III manufacture, and you will be part of this journey. It involves scaling up the drug substance (DS) process, conduct development experiments, defining the right quality level, specify/purchase/qualify equipment, and manufacture DS test batches. The unit operations of the DS process are extraction, particle separation, chromatography, ultra- and diafiltration, and stabilization.
Pilot Facility and Equipment is a development department within the pharmaceutical development function in R&D. The department currently consist of 10 persons. We are responsible for our pilot facility where we manufacture DS for clinical development, and we are also responsible for process development laboratories. We conduct various development studies and transfer processes from development into pilot scale.
As Principal Scientist in the department you will be part of the team that transfer processes into pilot scale, purchase and qualify new equipment (e.g., chromatography in large scale and ultra- and diafiltration equipment), conduct development studies and prepare for clinical phase II/III manufacture.
Changes in priorities often require flexibility and adaptability. We handle that with a smile while helping and learning from each other in an informal atmosphere characterized by enthusiasm and commitment.
Your profile
We expect you to have an academic education as an engineer, pharmacist, biochemist or similar, as well as experience with development work in the pharmaceutical industry, preferably with proteins. Also, we would like you to have theoretical and practical experience with equipment for GMP manufacture as well as experience with some of the DS unit operations mentioned above.
In addition, we expect that you:
What we offer
ALK offers a dynamic and pleasant working environment with inspiring and challenging tasks. The results of your efforts will be noticeable throughout the organisation, and you will have the opportunity to actively influence and challenge the status quo. Our flat structures attract independent individuals who like to feel the development of the business and enjoy being close to the decision-making process. You will be part of a committed and informal team that focuses on competencies and knowledge development. We consider our pioneering spirit combined with credibility to be the recipe for success. ALK is a health-focused organisation, and our offices are located in the scenic DTU Science Park in Hørsholm.
Apply
Apply by attaching your CV supplemented by a short letter of motivation. Application deadline is 19 February 2024. We evaluate applications and call for interviews on an ongoing basis, so don't wait to apply!
If you want to learn more about ALK we encourage you to visit us at www.alk.net. Do you have questions about the position, please contact Senior Manager, Jakob Howe Hjortkjær by telephone +45 41718466.
We look forward to hearing from you!
The position
We are about to start designing and qualifying new equipment for a new manufacturing process in our pilot facility for clinical phase II/III manufacture, and you will be part of this journey. It involves scaling up the drug substance (DS) process, conduct development experiments, defining the right quality level, specify/purchase/qualify equipment, and manufacture DS test batches. The unit operations of the DS process are extraction, particle separation, chromatography, ultra- and diafiltration, and stabilization.
Pilot Facility and Equipment is a development department within the pharmaceutical development function in R&D. The department currently consist of 10 persons. We are responsible for our pilot facility where we manufacture DS for clinical development, and we are also responsible for process development laboratories. We conduct various development studies and transfer processes from development into pilot scale.
As Principal Scientist in the department you will be part of the team that transfer processes into pilot scale, purchase and qualify new equipment (e.g., chromatography in large scale and ultra- and diafiltration equipment), conduct development studies and prepare for clinical phase II/III manufacture.
Changes in priorities often require flexibility and adaptability. We handle that with a smile while helping and learning from each other in an informal atmosphere characterized by enthusiasm and commitment.
Your profile
We expect you to have an academic education as an engineer, pharmacist, biochemist or similar, as well as experience with development work in the pharmaceutical industry, preferably with proteins. Also, we would like you to have theoretical and practical experience with equipment for GMP manufacture as well as experience with some of the DS unit operations mentioned above.
In addition, we expect that you:
- Enjoy going to the laboratory participating in the practical study execution and afterwards to work with data processing and reporting of the results obtained.
- Have experience with equipment qualification.
- Thrive on prioritizing your own tasks and meeting deadlines in a busy everyday life where you work independently and proactively.
- Communicate fluently, both orally and in writing in Danish and English.
- Are a good collaborator and sparring partner for your colleagues.
What we offer
ALK offers a dynamic and pleasant working environment with inspiring and challenging tasks. The results of your efforts will be noticeable throughout the organisation, and you will have the opportunity to actively influence and challenge the status quo. Our flat structures attract independent individuals who like to feel the development of the business and enjoy being close to the decision-making process. You will be part of a committed and informal team that focuses on competencies and knowledge development. We consider our pioneering spirit combined with credibility to be the recipe for success. ALK is a health-focused organisation, and our offices are located in the scenic DTU Science Park in Hørsholm.
Apply
Apply by attaching your CV supplemented by a short letter of motivation. Application deadline is 19 February 2024. We evaluate applications and call for interviews on an ongoing basis, so don't wait to apply!
If you want to learn more about ALK we encourage you to visit us at www.alk.net. Do you have questions about the position, please contact Senior Manager, Jakob Howe Hjortkjær by telephone +45 41718466.
We look forward to hearing from you!
Information og data
Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Hørsholm.
Jobbet er oprettet på vores service den 6.12.2023, 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.
- Forsker
- Hørsholm
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