*Operational Scientist, Mammalian Downstream

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We are seeking a dedicated scientist with solid experience within API production. AGC Biologics is a Contract Manufacturing Organization (CDMO) with facilities in Denmark, Germany, Italy, Japan and USA and with customers from all over the world. We have more than 30 nationalities employed and the daily language is English.

The Downstream Team

The team is part of the Mammalian Manufacturing Department responsible for the production of Drug Bulk Intermediate (DBI) / Active Pharmaceutical Ingredient (API) for pre-clinical, clinical and commercial use.

The Downstream production is using state of the art equipment units, such as UF/DF/TFF, Äkta systems, and different chromatography columns, and virus inactivation units. This is mainly done in a set-up in single use equipment.

The department is responsible for production activities on 3 different production lines working 24/7.  

The team consist of 50 technicians and 3 operational scientist, all headed up by one Manager referring to the head of Department and 5 Team Leads referring to the Manager. The whole department consists of two Upstream team, and two Downstream teams.

Organizational wise the Mammalian Manufacturing Department is currently under development due to an increased demand from our customers and also the construction of a new facility.

The position
AGC is currently expanding it's production capacity, with the onboarding of a new manufacturing facility. As Operational Scientist, your primary focus will be on the preparatory activities for the start-up of the facility. Your tasks in this phase of this role will include:

Development of tools and systems for production activities in the new facility, amongst other activities

Writing of TEQ's, SOP's, WOI's, Deviations, CC's CAPA's etc

Participating in qualification and onboarding of new equipment

Specializing in the new equipment and procedures and providing training to technicians.

After the facility is online, the role will transition to provision of support to Downstream technicians in all kind of production activities related to the individually project or batch.

It is important that you have solid experience with the equipment we use in order to provide the right support. The support will be in both technical matters when needed, and in process related subjects. This means, you can master numerous tasks and coordinate these in respect to both the technicians and leaders. In this position, you will have a broad influence and will corporate with many stakeholder in the entire organization.

As the production takes place 24/7 all year, it is important that you are able to work in a 3-shift plan with an equal amount of day, evening and night shifts.

In phase II of the role, your primary tasks will include:

Manage production activities for the technicians according to the production plan and if needed participate in the daily execution.

Coordination and preparation of activities for individual projects.(right equipment in the right place)

Perform unit operation training

Secure short term planning of individual activities

Secure and participate in daily shift handover

Support TL in all aspects

Maintenance of equipment

There is constant collaboration across the organization, and all employees have a professional and flexible attitude towards their work and to each other. In Mammalian downstream we value good corporation with a positive attitude.

Experience and competencies
The ideal candidate holds an MSc in Engeneering/downstream purification or Biochemistry or similar and experience within the production area in the pharmaceutical industry.

The ideal candidate for the position has several of the below competencies/experiences

+3 years of experience in the pharmaceutical industry working in an GMP environment

Solid knowledge in working with resins and columns such as Axichrom, BPG,RTP and Quick scale

Cleaning, packing and maintenance of columns

Can program methods in Unicorn

Knowledge of Labware7

Scientific downstream/purification understanding is a must

Strong communication skills (English)

Strong collaboration skills

LEAN oriented

Can cope with a high work pace in a dynamic environment

Structured and analytical oriented

Flexible

As a person you are highly motivated with a strong sense of urgency, a positive “can do” attitude and not afraid of taking responsibility for your tasks or together with stakeholders.

AGC Biologics offers
AGC Biologics offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. This opens many doors for personal development and for you to make a real difference towards both patients and customer. At AGC Biologics, the work

environment is informal and humor is part of the work day. We respect each other and our differences, and we help each other to reach deadlines together as one team.

For further information, please contact Diego Beronio, Team lead for Mammalian downstream Manufacturing Department, phone +45 6025 3363.

We will process the applications as they arrive. Therefore, please submit your resume and application as soon as possible.

Want to keep posted about our growth and to learn more about our company?

We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !

AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.


Information og data

Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i København

Jobbet er oprettet på vores service den 8.3.2024, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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