Scientist for GMP material qualification and coordination
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Hørsholm
Are you prepared to lead the way in the dynamic field of materials for GMP production? Would you like to take responsibility and drive activities related to materials? Do you like to navigate in an environment with diverse tasks and many stakeholders?
We are looking for people with different levels of seniority and experience to join our material support team and play an important role in setting the quality level and defining the processes in the world of materials at ALK.
In general, there is an increased focus on materials in pharmaceutical production related to both the regulatory requirements and the possibilities for production process optimizations, e.g., by using single-use-systems. At ALK this leads to an increase in material management activities such as supplier management, scientific and technical material evaluation, studies, and tests, as well as release setup, and ensuring materials are qualified and fit-for-purpose in the production processes.
The position
Our main responsibility is to implement and maintain material specifications and justifications as well as related GMP documentation. To do this we coordinate, drive, and execute on a broad range of activities both to support the daily operational flows and within the project organization when optimizing current or introducing new processes, technologies, and products. We do this in collaboration with many different stakeholders throughout the organization covering e.g., supplier management, supply chain planning, production, QC, QA, regulatory affairs, and development areas.
We ensure all necessary process and product requirements, material quality levels, and supplier risks are fulfilled to guarantee compliance and product safety. To evaluate that we use a risk-based approach covering rationales and risk assessments based on parameters throughout the processes from supplier to final product.
The team is responsible for the materials that are used in the production areas which can be single-use-systems, process supporting and aiding materials (e.g., containers, tubing, filters, connectors), primary packaging materials, excipients, solvents & reagents, etc.
An important part of our work is to continuously strengthen and at the same time simplify the processes and procedures around materials to ensure the right level of quality and compliance.
Primary tasks in the team:
Your profile
You can be an experienced senior profile or a newly graduate with some relevant pharmaceutical or manufacturing experience. We expect that you bring:
It is an advantage if you have knowledge and/or experience:
Personally, you are passionate about your assignments. You are open minded, have a positive attitude and thrive in an environment with many stakeholders throughout the company. You thrive with responsibility and have a structured way of working. At the same time, you are flexible and motivated by working in a busy environment where priorities and deadlines can change with short notice.
Become a part of ALK
We provide an attractive working environment for individuals looking for both personal and professional development. ALK is a global pharmaceutical company specialised in allergy immunotherapy. We are driven by a high level of professionalism, integrity, an openminded approach and contributing to an inspiring and fun working environment together with our colleagues. You will be part of an engaged and informal team who values skill and knowledge sharing. The result of your efforts will be significant throughout the organisation, and you will be able to actively influence and challenge the status quo.
Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm. We believe that physical presence enforces strong teamwork and collaboration and creates success, so it is important that you enjoy coming to work at our site with a degree of flexibility to also work from home.
Apply
Apply by attaching your CV and a short letter of motivation, no later than 5 August 2024.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We evaluate applications and call for interviews on an ongoing basis, so don't wait to apply! We reserve the right to take down the advert when we have found the right candidate(s).
Do you want to learn more about our company, we encourage you to visit us at www.alk.net. For further information regarding the position please contact Senior Manager, Material Support, Anders Malling Sørensen at +45 6191 3164.
We are looking forward to hearing from you!
We are looking for people with different levels of seniority and experience to join our material support team and play an important role in setting the quality level and defining the processes in the world of materials at ALK.
In general, there is an increased focus on materials in pharmaceutical production related to both the regulatory requirements and the possibilities for production process optimizations, e.g., by using single-use-systems. At ALK this leads to an increase in material management activities such as supplier management, scientific and technical material evaluation, studies, and tests, as well as release setup, and ensuring materials are qualified and fit-for-purpose in the production processes.
The position
Our main responsibility is to implement and maintain material specifications and justifications as well as related GMP documentation. To do this we coordinate, drive, and execute on a broad range of activities both to support the daily operational flows and within the project organization when optimizing current or introducing new processes, technologies, and products. We do this in collaboration with many different stakeholders throughout the organization covering e.g., supplier management, supply chain planning, production, QC, QA, regulatory affairs, and development areas.
We ensure all necessary process and product requirements, material quality levels, and supplier risks are fulfilled to guarantee compliance and product safety. To evaluate that we use a risk-based approach covering rationales and risk assessments based on parameters throughout the processes from supplier to final product.
The team is responsible for the materials that are used in the production areas which can be single-use-systems, process supporting and aiding materials (e.g., containers, tubing, filters, connectors), primary packaging materials, excipients, solvents & reagents, etc.
An important part of our work is to continuously strengthen and at the same time simplify the processes and procedures around materials to ensure the right level of quality and compliance.
Primary tasks in the team:
- Responsible for coordinating, driving, and executing material implementations and change activities in collaboration with a large variety of stakeholders.
- Establish and maintain material specifications, justification of specifications, risk evaluations and more.
- Establish, optimize, and simplify processes, procedures, and other related GMP documentation in the material landscape.
- Provide support, guidance, and scientific knowledge about materials to 1) Daily operational areas, 2) Project organization, 3) Development areas, as well as ensure quality and compliance to regulatory requirements.
- Participate in supplier management activities such as supplier selection, approval, evaluation, assessment of supplier change notifications, and issues with material quality or delivery from supplier.
- Participate in cross functional project with the responsibility for material related activities.
- Drive and provide input to continuous improvements related to process optimization, operational efficiency, cost saving, etc.
Your profile
You can be an experienced senior profile or a newly graduate with some relevant pharmaceutical or manufacturing experience. We expect that you bring:
- A bachelor’s or master’s degree in a relevant scientific field such as Chemistry, Biochemistry, Biology, Chemical Engineering, or a related discipline.
- GMP experience in the pharmaceutical industry preferably from a similar role.
- You have good collaboration and communication skills and understand the role of being in a support function.
- You are fluent in Danish and English spoken and written.
It is an advantage if you have knowledge and/or experience:
- with material management (e.g., implementation, handling and control of materials), and regulatory guidelines and standards within this area.
- with disposables, excipients etc. used for manufacturing processes.
- with container closure systems and primary packaging materials.
- in coordinating and driving activities with many stakeholders, or from a participation in small to medium complex projects.
Personally, you are passionate about your assignments. You are open minded, have a positive attitude and thrive in an environment with many stakeholders throughout the company. You thrive with responsibility and have a structured way of working. At the same time, you are flexible and motivated by working in a busy environment where priorities and deadlines can change with short notice.
Become a part of ALK
We provide an attractive working environment for individuals looking for both personal and professional development. ALK is a global pharmaceutical company specialised in allergy immunotherapy. We are driven by a high level of professionalism, integrity, an openminded approach and contributing to an inspiring and fun working environment together with our colleagues. You will be part of an engaged and informal team who values skill and knowledge sharing. The result of your efforts will be significant throughout the organisation, and you will be able to actively influence and challenge the status quo.
Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm. We believe that physical presence enforces strong teamwork and collaboration and creates success, so it is important that you enjoy coming to work at our site with a degree of flexibility to also work from home.
Apply
Apply by attaching your CV and a short letter of motivation, no later than 5 August 2024.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We evaluate applications and call for interviews on an ongoing basis, so don't wait to apply! We reserve the right to take down the advert when we have found the right candidate(s).
Do you want to learn more about our company, we encourage you to visit us at www.alk.net. For further information regarding the position please contact Senior Manager, Material Support, Anders Malling Sørensen at +45 6191 3164.
We are looking 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 5.7.2024, 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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