id: NDk4MDA1NSA3

reference: 4980055

documentId: 4980055

connectionPointId: 7

lastModificationDate: 1556541031996

stillingsbetegnelse: Upstream Process Scientist / Process Transfer

jobbeskrivelse:

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.

SUMMARY:

Maternity/temporary position - Upstream Process Scientist / Process Transfer

A challenging and varied job in our Process Transfer Department in Copenhagen as a 12-month temporary position is open for a quality-minded new colleague with mammalian upstream 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 mammalian upstream processing experience.

Principal Responsibilities:

Depending on your level of qualification, you will from a position in Process Transfer take part in key activities for upstream development in mainly in mammalian processes and to a minor extend microbial processes and be responsible for:

• Process transfers from customers and development into our manufacturing area

• Support to GMP upstream 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 upstream 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 abstractJV_description will depend on the profile of our new colleague.

The Department

In our Process Transfer department, we are currently 11 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.

KNOWLEDGE, SKILLS & ABILITIES

In our new colleague we’re looking for a person with:

• Knowledge of process development and bioreactor design/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 in working with people from various cultures and background

EDUCATION/EXPERIENCE:

• A minimum of 2 years’ experience with biopharmaceutical development and/or manufacturing

• Experience with biopharmaceutical upstream mammalian bioproduction

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, hnaested (at) agcbio.com

We will process the applications in the order they arrive. Therefore please submit your application and CV as soon as possible.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C3212

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: AGC Biologics A/S

source: DK-STAR