Manufacturing Associates for the Adjuvant Manufacturing Team

Do you want to join AGC Biologics on a journey to produce a product that hopefully can help the world out of its current health situation? Curios? Follow the link in the bottom of the job ad. 

Do you have experience with downstream processing and thrive in a dynamic work environment?  Would you like to be part of a company helping our customers bring new advanced biological products to market? Then join an international company where everyone is responsible for delivering right on time as one team!

With AGC Biologics increasing activities, we are looking for operators with experience preferably within API production or other areas within the pharmaceutical industry.

AGC Biologics is a Contract Manufacturing Organization (CDMO) with facilities in Denmark, Germany, Japan and USA and with customers from all over the world. We have more than 30 nationalities employed at our site in Copenhagen and the daily language is English.

The Adjuvant Manufacturing Team
The Adjuvant Manufacturing team is part of the larger Manufacturing function, which are responsible for the production of Drug Bulk Intermediate (DBI) and Active Pharmaceutical Ingredient (API) for pre-clinical, clinical and commercial use.

The team is under establishment and the manufacturing line is currently under construction. When fully staffed the department will consist of approx. 40 full time employees, covering shift supervisors, manufacturing specialist and manufacturing associates (operators).

The team will operate under cGMP and be responsible for running our dedicated adjuvant manufacturing line, executing unit operations as buffer preparation, homogenization, filtration, tangential flow filtrations and filling operations. As well as securing the compliance framework around the department, covering daily documentation of the operations, establishment and maintenance of SOPs, training documentation, deviation and CAPA management.

The position
As a Manufacturing Associate you will be part of a team that will be leading in manufacturing excellence, operating a very important part of our business. You will be responsible for:

• Perform the daily manufacturing activities, operate manufacturing equipment and perform individual unit operations according to SOPs and Batch production records
• Document all daily work and use of equipment according to cGMP
• Secure that daily production targets are meet and that next shift are setup for success
• Perform work according to all AGC’s procedures and policies to secure that all work is performed safe, compliant and reliable
• Support and perform troubleshooting on process and equipment challenges
• Support equipment maintenance and calibration activities 
• Support optimization and standardization of work processes
• If interested, author and update procedures and create logbooks

Experience and competencies
The ideal candidate holds an Technical degree, has downstream processing experience and has previously worked in a manufacturing team operating under cGMP preferably within the pharmaceutical industry. The ideal candidate for the position has several of the below competencies/experiences:

• A few years of experience from the pharmaceutical industry working in an cGMP environment
• Technical understanding of, tangential flow filtrations, solution preparation and lipid technologies is an advantage
• Experience with automated filtration systems and electronic batch records
• Experience with disposable manufacturing equipment
• Good communication skills (English)
• Structured and punctual
• Experience with Lean and a genuine interest in continues improvements

AGC offers
AGC Biologics offers a dynamic working place with good opportunities for 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.

Application

We cooperate with Adecco on recruitments. Accordingly Adecco will be responsible for the recruitment process. For more information about the position, please contact Adecco's recruitment team:


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