Downstream Process Scientist / Process Transfer
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Søborg
AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply. Right. On time. For more information, visit www.agcbio.com.
A challenging and varied job in our Process Transfer Department in Copenhagen is open for a quality-minded new colleague with downstream processing experience and a strong ability to drive interdepartmental collaboration.
The Job
AGC Biologics continues to enjoy great success, with a steadily increasing number of projects – many of which are late stage development projects preparing for commercial launch. More specifically, we have several projects active in the process validation stages from initial process risk assessment to execution of PPQ runs. At the same time, we are still handling many new and exciting customer projects and give support to processes already running in our GMP facility for clinical and commercial supply. With AGC Biologics increasing activities, we are looking for new colleagues with downstream processing experience and preferably with experience within process validation.
Depending on your level of qualification, you will from a position in Process Transfer take part in key activities for downstream development in both microbial and mammalian processes. You will be responsible for:
The position offer interaction with a large number of stakeholders, and is unique in having contact with both our customers and all internal departments involved in process development, manufacturing and validation of downstream processes. You will be introduced to biopharmaceutical companies from all over the world and be an active player in their projects. The daily challenges will vary a lot, and two days will never be the same.
The final job description will depend on the profile of our new colleague.
The Department
In our Process Transfer department, we are currently 15 highly skilled scientists, 3 student assistants, and 1 Director. We have an open communication and strong support and flexibility within the team.
The team is responsible for transfer of processes from customers to CMC Biologics and between development and manufacturing internally, as well as between CMC manufacturing sites globally (Denmark, United States, Germany, and Japan). Furthermore, the team is responsible for, and coordinates, process risk assessment and process validation activities. The team is recognized as a group of process subject matter experts and very often provides input in meetings with potential new customers and audits with authorities and costumers as SME’s.
Your profile
In our new colleague we’re looking for a person with:
AGC Biologics Copenhagen
AGC Biologics offers a dynamic working place and an excellent opportunity for working and growing with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a biologics contract development and manufacturing organization interact in order to achieve success. Exciting and challenging assignments will keep coming your way, but you will to a large extent be able to plan your daily work on your own. AGC Biologics offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC employees have a flexible attitude and we help each other to reach deadlines together as one team, complaint with our slogan - Right. On Time.
For further information please contact Henrik Næsted, Director of Process Transfer, [email protected]
Please submit your application and CV as soon as possible and no later than August 2nd, 2019.
Kilde: Jobnet.dk
A challenging and varied job in our Process Transfer Department in Copenhagen is open for a quality-minded new colleague with downstream processing experience and a strong ability to drive interdepartmental collaboration.
The Job
AGC Biologics continues to enjoy great success, with a steadily increasing number of projects – many of which are late stage development projects preparing for commercial launch. More specifically, we have several projects active in the process validation stages from initial process risk assessment to execution of PPQ runs. At the same time, we are still handling many new and exciting customer projects and give support to processes already running in our GMP facility for clinical and commercial supply. With AGC Biologics increasing activities, we are looking for new colleagues with downstream processing experience and preferably with experience within process validation.
Depending on your level of qualification, you will from a position in Process Transfer take part in key activities for downstream development in both microbial and mammalian processes. You will be responsible for:
- Process transfers from customers and development into our manufacturing area
- Process validation activities of downstream bioproduction preparing for marketing authorization
- Support to GMP downstream manufacturing processes
The position offer interaction with a large number of stakeholders, and is unique in having contact with both our customers and all internal departments involved in process development, manufacturing and validation of downstream processes. You will be introduced to biopharmaceutical companies from all over the world and be an active player in their projects. The daily challenges will vary a lot, and two days will never be the same.
The final job description will depend on the profile of our new colleague.
The Department
In our Process Transfer department, we are currently 15 highly skilled scientists, 3 student assistants, and 1 Director. We have an open communication and strong support and flexibility within the team.
The team is responsible for transfer of processes from customers to CMC Biologics and between development and manufacturing internally, as well as between CMC manufacturing sites globally (Denmark, United States, Germany, and Japan). Furthermore, the team is responsible for, and coordinates, process risk assessment and process validation activities. The team is recognized as a group of process subject matter experts and very often provides input in meetings with potential new customers and audits with authorities and costumers as SME’s.
Your profile
In our new colleague we’re looking for a person with:
- A minimum of 4 years’ experience with biopharmaceutical development and/or manufacturing
- Experience with biopharmaceutical downstream bioproduction
- Knowledge of process development and process technology
- cGMP experience
- Good English communication and collaborative people skills engaging with costumers and colleges of various cultural background, with an ability to obtain buy-in from all key stakeholders
- A flexible approach and desire to take on and drive new tasks and responsibilities
- Strong driver of interdepartmental tasks with the ability to keep the end goal in mind and prioritize between many different tasks
- Preferable - experience with process validation of biopharmaceutical would be an advantage
AGC Biologics Copenhagen
AGC Biologics offers a dynamic working place and an excellent opportunity for working and growing with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a biologics contract development and manufacturing organization interact in order to achieve success. Exciting and challenging assignments will keep coming your way, but you will to a large extent be able to plan your daily work on your own. AGC Biologics offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC employees have a flexible attitude and we help each other to reach deadlines together as one team, complaint with our slogan - Right. On Time.
For further information please contact Henrik Næsted, Director of Process Transfer, [email protected]
Please submit your application and CV as soon as possible and no later than August 2nd, 2019.
Kilde: Jobnet.dk
Information og data
Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 10.7.2019, 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
- Søborg
- Fredag den 02. august 2019
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